<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02232074</url>
  </required_header>
  <id_info>
    <org_study_id>H-32599</org_study_id>
    <secondary_id>RSG-13-368-01-CPPB</secondary_id>
    <secondary_id>AD-1304-6272</secondary_id>
    <nct_id>NCT02232074</nct_id>
  </id_info>
  <brief_title>Socio-legal Services for Underserved Populations Through Patient Navigation to Optimize Resources During Treatment</brief_title>
  <acronym>SUPPORT</acronym>
  <official_title>Project SUPPORT (Socio-legal Services for Underserved Populations Through Patient Navigation to Optimize Resources During Treatment)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Cancer Society, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators plan to compare standard patient navigation with an enhanced navigation&#xD;
      partnered with the Medical Legal Partnership | Boston (MLP) to determine if assessing legal&#xD;
      needs of newly diagnosed cancer patients in addition to other barriers to care leads to&#xD;
      better clinical outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Differences and delays in the delivery of cancer care lead to more advanced cancer at the&#xD;
      time of diagnosis and ultimately to more deaths for low-income and minority communities. Our&#xD;
      group helped develop a patient-navigation model using lay health workers to address patient&#xD;
      barriers and coordinated cancer-care services, leading to more timely care. Despite the fact&#xD;
      that patient navigation is now a standard required by the Commission on Cancer, the&#xD;
      investigators' research shows that delays in care persist for our low-income patients with&#xD;
      socio-legal barriers. Socio-legal barriers are defined as social problems related to meeting&#xD;
      life's most basic needs that are supported by public policy or programming and thus&#xD;
      potentially remedied through legal advocacy/action (e.g., unsafe/unstable housing, unlawful&#xD;
      utility shutoffs, or job termination). Direct feedback from cancer patients suggests a&#xD;
      critical need to address socio-legal barriers in order to achieve quality care for all. To&#xD;
      expand the current impact of patient navigation on quality care for low-income patients, the&#xD;
      investigators will partner with patients, key community stakeholders, and the Medical-Legal&#xD;
      Partnership (MLP)|Boston, the founding site of a nationwide program assisting healthcare&#xD;
      teams in addressing socio-legal barriers to health. Under direction from a Patient Advisory&#xD;
      Group and a Community Advisory Board, the investigators will conduct a study to compare&#xD;
      standard navigation with an MLP navigation intervention enhanced by legal support for&#xD;
      low-income cancer patients.&#xD;
&#xD;
      The investigators will enroll 374 low-income, racially diverse, newly diagnosed cancer&#xD;
      patients. Half will receive standard navigation, i.e., a lay navigator integrated into the&#xD;
      healthcare team who provides one-on-one patient contact to address traditional system&#xD;
      barriers to care. The other half will receive MLP navigation, i.e., standard navigation&#xD;
      enhanced by legal support including:&#xD;
&#xD;
        1. a full socio-legal needs assessment and care plan in consultation with MLP; and&#xD;
&#xD;
        2. legal assistance for eligible urgent legal needs. We will compare each group on all&#xD;
           outcomes.&#xD;
&#xD;
      Compared to standard navigation, we expect that addressing socio-legal barriers to care with&#xD;
      MLP navigation will improve patient-reported outcomes and lead to more timely care delivery.&#xD;
      Because of widespread national availability of patient navigation and MLP programs at&#xD;
      hospitals serving vulnerable patients, this intervention can be quickly replicated to improve&#xD;
      patient experience and survival.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2014</start_date>
  <completion_date type="Actual">October 1, 2018</completion_date>
  <primary_completion_date type="Actual">April 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among BREAST Cancer Participants</measure>
    <time_frame>Receipt of 1st treatment within 90 days from diagnosis</time_frame>
    <description>The receipt of timely care will be defined as initiation of care within 90 days, as this the shortest delay that has been shown to consistently affect mortality The time element was calculated from date of diagnosis (Time0) to date of treatment initiation (Time1) .The date chosen for the Time1 variable depends on the recommended care plan for each patient, as derived from the chart abstraction and based on patient presentation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among LUNG Cancer Participants</measure>
    <time_frame>Receipt of 1st treatment within 90 days from diagnosis</time_frame>
    <description>The receipt of timely care will be defined as initiation of care within 90 days, as this the shortest delay that has been shown to consistently affect mortality The time element was calculated from date of diagnosis (Time0) to date of treatment initiation (Time1) .The date chosen for the Time1 variable depends on the recommended care plan for each patient, as derived from the chart abstraction and based on patient presentation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Distress Thermometer at 3 Months for BREAST Cancer Patients</measure>
    <time_frame>3 months after enrollment</time_frame>
    <description>Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower values are more favorable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distress Thermometer at 3 Months for LUNG Cancer Patients</measure>
    <time_frame>3 months after enrollment</time_frame>
    <description>Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower values are more favorable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distress Thermometer at 6 Months for BREAST Cancer Patients</measure>
    <time_frame>6 months after enrollment</time_frame>
    <description>Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower values are more favorable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distress Thermometer at 6 Months for LUNG Cancer Patients</measure>
    <time_frame>6 months after enrollment</time_frame>
    <description>Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress).Lower values are more favorable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer Needs and Distress Inventory at 6 Months for BREAST Cancer Patients</measure>
    <time_frame>6 months post-enrollment</time_frame>
    <description>Patient needs were assessed through patient interviews utilizing the Cancer Needs Distress Inventory (CaNDI) instrument. The CaNDI is a 38-item self-report instrument that rates need and distress level in the past two weeks using a 5 -point Likert scale where 1=not a problem to 5=very severe problem. For this analysis, the mean total score is reported with the minimum value=1 and the maximum value=4.10. Lower values are more favorable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer Needs and Distress Inventory at 6 Months for LUNG Cancer Patients</measure>
    <time_frame>6 months post-enrollment</time_frame>
    <description>Patient needs were assessed through patient interviews utilizing the Cancer Needs Distress Inventory (CaNDI) instrument. The CaNDI is a 38-item self-report instrument that rates need and distress level in the past two weeks using a 5 -point Likert scale where 1=not a problem to 5=very severe problem. For this analysis, the mean total score is reported with the minimum value=1 and the maximum value=2.3. Lower values are more favorable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction With Navigation at 6 Months Among BREAST Cancer Patients</measure>
    <time_frame>6 months post-enrollment</time_frame>
    <description>Patient's satisfaction assessed through the Patient Satisfaction with Interpersonal Relationship with Navigator Measure (PSN-1) questionnaire. Each question of the 9-item instrument has a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Responses are summed for a total score. The higher the score, the higher patient's satisfaction with navigation. The minimum value=9 and the maximum value=45. Higher values are more favorable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction With Navigation at 6 Months Among LUNG Cancer Patients</measure>
    <time_frame>6 months post-enrollment</time_frame>
    <description>Patient's satisfaction assessed through the Patient Satisfaction with Interpersonal Relationship with Navigator Measure (PSN-1) questionnaire. Each question of the 9-item instrument has a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Responses are summed for a total score. The higher the score, the higher patient's satisfaction with navigation. The minimum value=9 and the maximum value=45. Higher values are more favorable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy for BREAST Cancer Patients at 6 Months</measure>
    <time_frame>6 months post-enrollment</time_frame>
    <description>Self-Efficacy will be assessed through patient interviews utilizing the Communication and Attitudinal Self-Efficacy (CASE). The CASE is a 12-item instrument that rates self-efficacy in three domains: (1) seeking and obtaining information, (2) understanding and participating in care, and (3) maintaining a positive attitude. Total scores range from 12 to 48. A higher score is more favorable, indicating a positive attitude and strong self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy for LUNG Cancer Patients at 6 Months</measure>
    <time_frame>6 months post-enrollment</time_frame>
    <description>Self-Efficacy will be assessed through patient interviews utilizing the Communication and Attitudinal Self-Efficacy (CASE). The CASE is a 12-item instrument that rates self-efficacy in three domains: (1) seeking and obtaining information, (2) understanding and participating in care, and (3) maintaining a positive attitude. Total scores range from 12 to 48. A higher score is more favorable, indicating a positive attitude and strong self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Receiving Radiation Within 365 Days of Cancer Diagnosis</measure>
    <time_frame>Measured at 12 months</time_frame>
    <description>The receipt of quality care is defined as receiving radiation to the breast within one year of a breast cancer diagnosis if: under the age of 70, estrogen or progesterone tumor positive and had breast conserving surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distress Thermometer at 12 Months for BREAST Cancer Patients</measure>
    <time_frame>12 months after enrollment</time_frame>
    <description>Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower values are more favorable</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distress Thermometer at 12 Months for LUNG Cancer Patients</measure>
    <time_frame>12 months after enrollment</time_frame>
    <description>Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower scores are more favorable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer Needs and Distress Inventory at 12 Months for BREAST Cancer Patients</measure>
    <time_frame>12 months post-enrollment</time_frame>
    <description>Patient needs were assessed through patient interviews utilizing the Cancer Needs Distress Inventory (CaNDI) instrument. The CaNDI is a 38-item self-report instrument that rates need and distress level in the past two weeks using a 5 -point Likert scale where 1=not a problem to 5=very severe problem. The mean total score is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer Needs and Distress Inventory at 12 Months for LUNG Cancer Patients</measure>
    <time_frame>12 months post-enrollment</time_frame>
    <description>Patient needs were assessed through patient interviews utilizing the Cancer Needs Distress Inventory (CaNDI) instrument. The CaNDI is a 38-item self-report instrument that rates need and distress level in the past two weeks using a 5 -point Likert scale where 1=not a problem to 5=very severe problem. The mean total score is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction With Navigation at 12 Months Among BREAST Cancer Patients</measure>
    <time_frame>12 months post-enrollment</time_frame>
    <description>Patient's satisfaction assessed through the Patient Satisfaction with Interpersonal Relationship with Navigator Measure (PSN-1) questionnaire. Each question of the 9-item instrument has a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Responses are summed for a total score. The higher the score, the higher patient's satisfaction with navigation. The minimum value=9 and the maximum value=45. Higher scores are more favorable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction With Navigation at 12 Months Among LUNG Cancer Patients</measure>
    <time_frame>12 months post-enrollment</time_frame>
    <description>Patient's satisfaction assessed through the Patient Satisfaction with Interpersonal Relationship with Navigator Measure (PSN-1) questionnaire. Each question of the 9-item instrument has a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Responses are summed for a total score. The higher the score, the higher patient's satisfaction with navigation. The minimum value=9 and the maximum value=45. Higher scores are more favorable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy for BREAST Cancer Patients at 12 Months</measure>
    <time_frame>12 months post-enrollment</time_frame>
    <description>Self-Efficacy will be assessed through patient interviews utilizing the Communication and Attitudinal Self-Efficacy (CASE). The CASE is a 12-item instrument that rates self-efficacy in three domains: (1) seeking and obtaining information, (2) understanding and participating in care, and (3) maintaining a positive attitude. A higher score indicates a positive attitude and strong self-efficacy. Total scores range from 12 to 48. A higher score is more favorable, indicating a positive attitude and strong self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy for LUNG Cancer Patients at 12 Months</measure>
    <time_frame>12 months post-enrollment</time_frame>
    <description>Self-Efficacy will be assessed through patient interviews utilizing the Communication and Attitudinal Self-Efficacy (CASE). The CASE is a 12-item instrument that rates self-efficacy in three domains: (1) seeking and obtaining information, (2) understanding and participating in care, and (3) maintaining a positive attitude. A higher score indicates a positive attitude and strong self-efficacy. Total scores range from 12 to 48. A higher score is more favorable, indicating a positive attitude and strong self-efficacy.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">306</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Patient navigation enhanced with legal support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to receiving standard navigation, patients will be connected with a Patient Navigator who is partnered with a lawyer from Medical-Legal Partnership to provide personalized assistance with regard to social-legal barriers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard patient navigation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>These patients will receive standard patient navigation which will work to ensure that services are coordinated amongst medical personnel, while also addressing patients' needs.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient navigation enhanced with legal support</intervention_name>
    <arm_group_label>Patient navigation enhanced with legal support</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosed breast and lung cancer patients&#xD;
&#xD;
          -  Within 30 days of patient being informed of diagnosis&#xD;
&#xD;
          -  Receiving cancer care at Boston Medical Center&#xD;
&#xD;
          -  No history of cancer treatment in past 5 years&#xD;
&#xD;
          -  No cognitive impairments&#xD;
&#xD;
          -  Over 18 years of age&#xD;
&#xD;
          -  Speak English, Spanish or Haitian Creole&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient informed of cancer diagnosis &gt;30 days&#xD;
&#xD;
          -  Patient under 18 yrs. of age&#xD;
&#xD;
          -  Primary language something other than English, Spanish or Haitian Creole&#xD;
&#xD;
          -  Undergoing treatment for concurrent cancer&#xD;
&#xD;
          -  Patient has history of cancer or has received cancer treatment within the last 5 years&#xD;
&#xD;
          -  Institutionalized/cognitive impairment (such as: dementia or metabolic, medication or&#xD;
             drug induced), given the unique challenges to their treatment decision&#xD;
             making/adherence and the fact that the intervention would not include the patient&#xD;
             directly, but rather the family.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tracy A Battaglia, M.D., M.P.H</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sharon Bak, M.P.H</last_name>
    <role>Study Director</role>
    <affiliation>Boston Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <results_first_submitted>December 26, 2018</results_first_submitted>
  <results_first_submitted_qc>April 22, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 11, 2019</results_first_posted>
  <last_update_submitted>October 2, 2019</last_update_submitted>
  <last_update_submitted_qc>October 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Medical Center</investigator_affiliation>
    <investigator_full_name>Battaglia, Tracy</investigator_full_name>
    <investigator_title>Associate Professor of Medicine and Epidemiology, Boston University School of Medicine, Chief of Women's Health Unit</investigator_title>
  </responsible_party>
  <keyword>Patient Navigation</keyword>
  <keyword>Medical Legal Partnership</keyword>
  <keyword>Healthcare Disparities</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 7, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT02232074/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 1, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT02232074/Prot_ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Patient Navigation With Legal Support</title>
          <description>For those with legal concerns at baseline identified by the IHELP screening tool, intervention participants received Patient Navigation enhance with legal support.</description>
        </group>
        <group group_id="P2">
          <title>Standard Patient Navigation</title>
          <description>For those with legal concerns at baseline identified by the IHELP screening tool, control participants received standard of care Patient Navigation</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="154"/>
                <participants group_id="P2" count="152"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="113"/>
                <participants group_id="P2" count="107"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="45"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No legal concerns at baseline</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="41"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>deemed ineligible</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Analysis includes those participants with at least 1 legal concern at baseline.</population>
      <group_list>
        <group group_id="B1">
          <title>Patient Navigation With Legal Support</title>
          <description>For those with legal concerns at baseline identified by the IHELP screening tool, intervention participants received Patient Navigation enhance with legal support.</description>
        </group>
        <group group_id="B2">
          <title>Standard Patient Navigation</title>
          <description>For those with legal concerns at baseline identified by the IHELP screening tool, control participants received standard of care Patient Navigation</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="113"/>
            <count group_id="B2" value="107"/>
            <count group_id="B3" value="220"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Analysis includes those participants with at least 1 legal concern at baseline.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.6" spread="11.0"/>
                    <measurement group_id="B2" value="54.7" spread="11.0"/>
                    <measurement group_id="B3" value="55.1" spread="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="109"/>
                    <measurement group_id="B2" value="102"/>
                    <measurement group_id="B3" value="211"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race / Ethnicity</title>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black \ African-American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="111"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Language</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>English</title>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="158"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Spanish</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Haitian Creole</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Insurance</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Public</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="162"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Private</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among BREAST Cancer Participants</title>
        <description>The receipt of timely care will be defined as initiation of care within 90 days, as this the shortest delay that has been shown to consistently affect mortality The time element was calculated from date of diagnosis (Time0) to date of treatment initiation (Time1) .The date chosen for the Time1 variable depends on the recommended care plan for each patient, as derived from the chart abstraction and based on patient presentation.</description>
        <time_frame>Receipt of 1st treatment within 90 days from diagnosis</time_frame>
        <population>breast cancer participants with 1 or more legal concern as screened at baseline using the IHELP survey.</population>
        <group_list>
          <group group_id="O1">
            <title>Breast Cancer Intervention</title>
            <description>For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.</description>
          </group>
          <group group_id="O2">
            <title>Breast Cancer Control</title>
            <description>For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among BREAST Cancer Participants</title>
          <description>The receipt of timely care will be defined as initiation of care within 90 days, as this the shortest delay that has been shown to consistently affect mortality The time element was calculated from date of diagnosis (Time0) to date of treatment initiation (Time1) .The date chosen for the Time1 variable depends on the recommended care plan for each patient, as derived from the chart abstraction and based on patient presentation.</description>
          <population>breast cancer participants with 1 or more legal concern as screened at baseline using the IHELP survey.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="96"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94"/>
                    <measurement group_id="O2" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Compared to the control group, the Breast cancer INTERVENTION group will be more likely to have timely first treatment (i.e. receipt of first treatment within 90 days of diagnosis).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.77</p_value>
            <p_value_desc>a priori threshold for statistical significance p&lt;0.05</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.21</ci_lower_limit>
            <ci_upper_limit>3.14</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among LUNG Cancer Participants</title>
        <description>The receipt of timely care will be defined as initiation of care within 90 days, as this the shortest delay that has been shown to consistently affect mortality The time element was calculated from date of diagnosis (Time0) to date of treatment initiation (Time1) .The date chosen for the Time1 variable depends on the recommended care plan for each patient, as derived from the chart abstraction and based on patient presentation.</description>
        <time_frame>Receipt of 1st treatment within 90 days from diagnosis</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lung Cancer Intervention</title>
            <description>For lung cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.</description>
          </group>
          <group group_id="O2">
            <title>Lung Cancer Control</title>
            <description>For lung cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among LUNG Cancer Participants</title>
          <description>The receipt of timely care will be defined as initiation of care within 90 days, as this the shortest delay that has been shown to consistently affect mortality The time element was calculated from date of diagnosis (Time0) to date of treatment initiation (Time1) .The date chosen for the Time1 variable depends on the recommended care plan for each patient, as derived from the chart abstraction and based on patient presentation.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Compared to the control group, the Lung cancer INTERVENTION group will be more likely to have timely first treatment (i.e. receipt of first treatment within 90 days of diagnosis).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.26</p_value>
            <p_value_desc>a priori threshold for statistical significance p&lt;0.05</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>4.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.35</ci_lower_limit>
            <ci_upper_limit>45.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distress Thermometer at 3 Months for BREAST Cancer Patients</title>
        <description>Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower values are more favorable.</description>
        <time_frame>3 months after enrollment</time_frame>
        <population>The number of Intervention participants decreased by 5 to 99 and Control participants decreased by 3 to 90 due to missing Distress Thermometer data at 3 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Breast Cancer Intervention</title>
            <description>For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.</description>
          </group>
          <group group_id="O2">
            <title>Breast Cancer Control</title>
            <description>For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.</description>
          </group>
        </group_list>
        <measure>
          <title>Distress Thermometer at 3 Months for BREAST Cancer Patients</title>
          <description>Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower values are more favorable.</description>
          <population>The number of Intervention participants decreased by 5 to 99 and Control participants decreased by 3 to 90 due to missing Distress Thermometer data at 3 months.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.60" spread="3.20"/>
                    <measurement group_id="O2" value="5.90" spread="3.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Compared to the control group, the Breast cancer INTERVENTION group will have less distress at 3 months post-enrollment</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.53</p_value>
            <p_value_desc>a priori threshold for statistical significance p&lt;0.05</p_value_desc>
            <method>Regression, Linear</method>
            <method_desc>Adjusting for baseline Distress Thermometer scores.</method_desc>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-0.27</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.42</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distress Thermometer at 3 Months for LUNG Cancer Patients</title>
        <description>Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower values are more favorable.</description>
        <time_frame>3 months after enrollment</time_frame>
        <population>The number of LUNG Control participants decreased by 3 for a total of 8 due to missing Distress Thermometer data at 3 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Lung Cancer Intervention</title>
            <description>For lung cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.</description>
          </group>
          <group group_id="O2">
            <title>Lung Cancer Control</title>
            <description>For lung cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.</description>
          </group>
        </group_list>
        <measure>
          <title>Distress Thermometer at 3 Months for LUNG Cancer Patients</title>
          <description>Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower values are more favorable.</description>
          <population>The number of LUNG Control participants decreased by 3 for a total of 8 due to missing Distress Thermometer data at 3 months.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.50" spread="3.20"/>
                    <measurement group_id="O2" value="6.10" spread="2.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Compared to the control group, the LUNG cancer INTERVENTION group will have less distress at 3 months post-enrollment</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.43</p_value>
            <p_value_desc>Adjusting for baseline Distress Thermometer scores.</p_value_desc>
            <method>Regression, Linear</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-1.32</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.62</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distress Thermometer at 6 Months for BREAST Cancer Patients</title>
        <description>Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower values are more favorable.</description>
        <time_frame>6 months after enrollment</time_frame>
        <population>The number of BREAST Intervention participants decreased by 13 for a total of 91 and Control participants decreased by 8 for a total of 58 due to missing Distress Thermometer data at 6 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Breast Cancer Intervention</title>
            <description>For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.</description>
          </group>
          <group group_id="O2">
            <title>Breast Cancer Control</title>
            <description>For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.</description>
          </group>
        </group_list>
        <measure>
          <title>Distress Thermometer at 6 Months for BREAST Cancer Patients</title>
          <description>Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower values are more favorable.</description>
          <population>The number of BREAST Intervention participants decreased by 13 for a total of 91 and Control participants decreased by 8 for a total of 58 due to missing Distress Thermometer data at 6 months.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="85"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.50" spread="3.30"/>
                    <measurement group_id="O2" value="5.20" spread="3.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Compared to the control group, the Breast cancer INTERVENTION group will have less distress at 6 months post-enrollment</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.18</p_value>
            <p_value_desc>a priori threshold for statistical significance p&lt;0.05</p_value_desc>
            <method>Regression, Linear</method>
            <method_desc>Adjusting for baseline Distress Thermometer scores.</method_desc>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-0.60</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.45</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distress Thermometer at 6 Months for LUNG Cancer Patients</title>
        <description>Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress).Lower values are more favorable.</description>
        <time_frame>6 months after enrollment</time_frame>
        <population>The number of LUNG Intervention participants decreased by 2 for a total of 6 and Control patients decreased by 4 due to missing Distress Thermometer data at 6 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Lung Cancer Intervention</title>
            <description>For lung cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.</description>
          </group>
          <group group_id="O2">
            <title>Lung Cancer Control</title>
            <description>For lung cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.</description>
          </group>
        </group_list>
        <measure>
          <title>Distress Thermometer at 6 Months for LUNG Cancer Patients</title>
          <description>Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress).Lower values are more favorable.</description>
          <population>The number of LUNG Intervention participants decreased by 2 for a total of 6 and Control patients decreased by 4 due to missing Distress Thermometer data at 6 months.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.50" spread="1.90"/>
                    <measurement group_id="O2" value="4.00" spread="2.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Compared to the control group, the Lung cancer INTERVENTION group will have less distress at 6 months post-enrollment</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.33</p_value>
            <p_value_desc>a priori threshold for statistical significance p&lt;0.05</p_value_desc>
            <method>Regression, Linear</method>
            <method_desc>Adjusting for baseline Distress Thermometer scores.</method_desc>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-1.33</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.29</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cancer Needs and Distress Inventory at 6 Months for BREAST Cancer Patients</title>
        <description>Patient needs were assessed through patient interviews utilizing the Cancer Needs Distress Inventory (CaNDI) instrument. The CaNDI is a 38-item self-report instrument that rates need and distress level in the past two weeks using a 5 -point Likert scale where 1=not a problem to 5=very severe problem. For this analysis, the mean total score is reported with the minimum value=1 and the maximum value=4.10. Lower values are more favorable.</description>
        <time_frame>6 months post-enrollment</time_frame>
        <population>The number of Breast Intervention participants decreased by 13 to 91 and the Control participants decreased by 8 to 85 due to missing CaNDi data at 6 month follow up</population>
        <group_list>
          <group group_id="O1">
            <title>Breast Cancer Intervention</title>
            <description>For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.</description>
          </group>
          <group group_id="O2">
            <title>Breast Cancer Control</title>
            <description>For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.</description>
          </group>
        </group_list>
        <measure>
          <title>Cancer Needs and Distress Inventory at 6 Months for BREAST Cancer Patients</title>
          <description>Patient needs were assessed through patient interviews utilizing the Cancer Needs Distress Inventory (CaNDI) instrument. The CaNDI is a 38-item self-report instrument that rates need and distress level in the past two weeks using a 5 -point Likert scale where 1=not a problem to 5=very severe problem. For this analysis, the mean total score is reported with the minimum value=1 and the maximum value=4.10. Lower values are more favorable.</description>
          <population>The number of Breast Intervention participants decreased by 13 to 91 and the Control participants decreased by 8 to 85 due to missing CaNDi data at 6 month follow up</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="85"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.70" spread="0.70"/>
                    <measurement group_id="O2" value="1.70" spread="0.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.68</p_value>
            <p_value_desc>a priori threshold for statistical significance p&lt;0.05</p_value_desc>
            <method>Regression, Linear</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>0.03</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.07</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cancer Needs and Distress Inventory at 6 Months for LUNG Cancer Patients</title>
        <description>Patient needs were assessed through patient interviews utilizing the Cancer Needs Distress Inventory (CaNDI) instrument. The CaNDI is a 38-item self-report instrument that rates need and distress level in the past two weeks using a 5 -point Likert scale where 1=not a problem to 5=very severe problem. For this analysis, the mean total score is reported with the minimum value=1 and the maximum value=2.3. Lower values are more favorable.</description>
        <time_frame>6 months post-enrollment</time_frame>
        <population>The number of Lung Intervention participants decreased by 2 to 6 and the Control participants decreased by 4 to 7 due to missing CaNDi data at 6 month follow up</population>
        <group_list>
          <group group_id="O1">
            <title>Lung Cancer Intervention</title>
            <description>For Lung cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.</description>
          </group>
          <group group_id="O2">
            <title>Lung Cancer Control</title>
            <description>For Lung cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.</description>
          </group>
        </group_list>
        <measure>
          <title>Cancer Needs and Distress Inventory at 6 Months for LUNG Cancer Patients</title>
          <description>Patient needs were assessed through patient interviews utilizing the Cancer Needs Distress Inventory (CaNDI) instrument. The CaNDI is a 38-item self-report instrument that rates need and distress level in the past two weeks using a 5 -point Likert scale where 1=not a problem to 5=very severe problem. For this analysis, the mean total score is reported with the minimum value=1 and the maximum value=2.3. Lower values are more favorable.</description>
          <population>The number of Lung Intervention participants decreased by 2 to 6 and the Control participants decreased by 4 to 7 due to missing CaNDi data at 6 month follow up</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.40" spread="0.40"/>
                    <measurement group_id="O2" value="1.50" spread="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.26</p_value>
            <p_value_desc>a priori threshold for statistical significance p&lt;0.05</p_value_desc>
            <method>Regression, Linear</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-0.18</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.15</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction With Navigation at 6 Months Among BREAST Cancer Patients</title>
        <description>Patient's satisfaction assessed through the Patient Satisfaction with Interpersonal Relationship with Navigator Measure (PSN-1) questionnaire. Each question of the 9-item instrument has a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Responses are summed for a total score. The higher the score, the higher patient's satisfaction with navigation. The minimum value=9 and the maximum value=45. Higher values are more favorable.</description>
        <time_frame>6 months post-enrollment</time_frame>
        <population>Linear regression tested for an association between the intervention &amp; control groups in satisfaction with patient navigation at six months post-enrollment. The number of Breast Intervention participants decreased by 52 to 52 and the Control participants decreased by 41 to 52 due to missing Patient Satisfaction data at 6 month follow up</population>
        <group_list>
          <group group_id="O1">
            <title>Breast Cancer Intervention</title>
            <description>For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.</description>
          </group>
          <group group_id="O2">
            <title>Breast Cancer Control</title>
            <description>For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With Navigation at 6 Months Among BREAST Cancer Patients</title>
          <description>Patient's satisfaction assessed through the Patient Satisfaction with Interpersonal Relationship with Navigator Measure (PSN-1) questionnaire. Each question of the 9-item instrument has a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Responses are summed for a total score. The higher the score, the higher patient's satisfaction with navigation. The minimum value=9 and the maximum value=45. Higher values are more favorable.</description>
          <population>Linear regression tested for an association between the intervention &amp; control groups in satisfaction with patient navigation at six months post-enrollment. The number of Breast Intervention participants decreased by 52 to 52 and the Control participants decreased by 41 to 52 due to missing Patient Satisfaction data at 6 month follow up</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.4" spread="7.44"/>
                    <measurement group_id="O2" value="39.7" spread="7.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Compared to the control group, the Breast cancer INTERVENTION group will be more satisfied with patient navigation at 6 months post-enrollment</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.62</p_value>
            <p_value_desc>a priori threshold for statistical significance p&lt;0.05</p_value_desc>
            <method>Regression, Linear</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>0.71</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.43</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction With Navigation at 6 Months Among LUNG Cancer Patients</title>
        <description>Patient's satisfaction assessed through the Patient Satisfaction with Interpersonal Relationship with Navigator Measure (PSN-1) questionnaire. Each question of the 9-item instrument has a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Responses are summed for a total score. The higher the score, the higher patient's satisfaction with navigation. The minimum value=9 and the maximum value=45. Higher values are more favorable.</description>
        <time_frame>6 months post-enrollment</time_frame>
        <population>Linear regression tested for an association between the intervention &amp; control groups in satisfaction with patient navigation at six months post-enrollment. The number of LUNG Intervention participants decreased by 4 to 4 and the Control participants decreased by 8 to 3 due to missing Patient Satisfaction data at 6 month follow up</population>
        <group_list>
          <group group_id="O1">
            <title>Lung Cancer Intervention</title>
            <description>For lung cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.</description>
          </group>
          <group group_id="O2">
            <title>Lung Cancer Control</title>
            <description>For lung cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With Navigation at 6 Months Among LUNG Cancer Patients</title>
          <description>Patient's satisfaction assessed through the Patient Satisfaction with Interpersonal Relationship with Navigator Measure (PSN-1) questionnaire. Each question of the 9-item instrument has a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Responses are summed for a total score. The higher the score, the higher patient's satisfaction with navigation. The minimum value=9 and the maximum value=45. Higher values are more favorable.</description>
          <population>Linear regression tested for an association between the intervention &amp; control groups in satisfaction with patient navigation at six months post-enrollment. The number of LUNG Intervention participants decreased by 4 to 4 and the Control participants decreased by 8 to 3 due to missing Patient Satisfaction data at 6 month follow up</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.3" spread="4.43"/>
                    <measurement group_id="O2" value="39.0" spread="2.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Compared to the control group, the Lung cancer INTERVENTION group will be more satisfied with patient navigation at 6 months post-enrollment</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.69</p_value>
            <p_value_desc>a priori threshold for statistical significance p&lt;0.05</p_value_desc>
            <method>Regression, Linear</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>1.25</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.91</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Self-efficacy for BREAST Cancer Patients at 6 Months</title>
        <description>Self-Efficacy will be assessed through patient interviews utilizing the Communication and Attitudinal Self-Efficacy (CASE). The CASE is a 12-item instrument that rates self-efficacy in three domains: (1) seeking and obtaining information, (2) understanding and participating in care, and (3) maintaining a positive attitude. Total scores range from 12 to 48. A higher score is more favorable, indicating a positive attitude and strong self-efficacy.</description>
        <time_frame>6 months post-enrollment</time_frame>
        <population>Within each cancer group (breast &amp; lung cancers analyzed separately), a linear regression was used to test whether there was an association between the intervention &amp; control groups in self-efficacy at six months post-enrollment, adjusting for baseline CASE Cancer score.</population>
        <group_list>
          <group group_id="O1">
            <title>Breast Cancer Intervention</title>
            <description>For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.</description>
          </group>
          <group group_id="O2">
            <title>Breast Cancer Control</title>
            <description>For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-efficacy for BREAST Cancer Patients at 6 Months</title>
          <description>Self-Efficacy will be assessed through patient interviews utilizing the Communication and Attitudinal Self-Efficacy (CASE). The CASE is a 12-item instrument that rates self-efficacy in three domains: (1) seeking and obtaining information, (2) understanding and participating in care, and (3) maintaining a positive attitude. Total scores range from 12 to 48. A higher score is more favorable, indicating a positive attitude and strong self-efficacy.</description>
          <population>Within each cancer group (breast &amp; lung cancers analyzed separately), a linear regression was used to test whether there was an association between the intervention &amp; control groups in self-efficacy at six months post-enrollment, adjusting for baseline CASE Cancer score.</population>
          <units>total score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.0" spread="5.2"/>
                    <measurement group_id="O2" value="43.3" spread="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Compared to the control group, the breast cancer INTERVENTION group would have higher self-efficacy was adjusting for baseline self-efficacy scores.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.58</p_value>
            <p_value_desc>a priori threshold for statistical significance p&lt;0.05</p_value_desc>
            <method>Regression, Linear</method>
            <method_desc>adjusting for baseline Case scores.</method_desc>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>0.33</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.59</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Self-efficacy for LUNG Cancer Patients at 6 Months</title>
        <description>Self-Efficacy will be assessed through patient interviews utilizing the Communication and Attitudinal Self-Efficacy (CASE). The CASE is a 12-item instrument that rates self-efficacy in three domains: (1) seeking and obtaining information, (2) understanding and participating in care, and (3) maintaining a positive attitude. Total scores range from 12 to 48. A higher score is more favorable, indicating a positive attitude and strong self-efficacy.</description>
        <time_frame>6 months post-enrollment</time_frame>
        <population>Within each cancer group (breast &amp; lung cancers analyzed separately), a linear regression was used to test whether there was an association between the intervention &amp; control groups in self-efficacy at six months post-enrollment, adjusting for baseline CASE Cancer score.</population>
        <group_list>
          <group group_id="O1">
            <title>Lung Cancer Intervention</title>
            <description>For lung cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.</description>
          </group>
          <group group_id="O2">
            <title>Lung Cancer Control</title>
            <description>For Lung cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-efficacy for LUNG Cancer Patients at 6 Months</title>
          <description>Self-Efficacy will be assessed through patient interviews utilizing the Communication and Attitudinal Self-Efficacy (CASE). The CASE is a 12-item instrument that rates self-efficacy in three domains: (1) seeking and obtaining information, (2) understanding and participating in care, and (3) maintaining a positive attitude. Total scores range from 12 to 48. A higher score is more favorable, indicating a positive attitude and strong self-efficacy.</description>
          <population>Within each cancer group (breast &amp; lung cancers analyzed separately), a linear regression was used to test whether there was an association between the intervention &amp; control groups in self-efficacy at six months post-enrollment, adjusting for baseline CASE Cancer score.</population>
          <units>total score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.0" spread="0.90"/>
                    <measurement group_id="O2" value="43.0" spread="5.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Compared to the control group, the lung cancer INTERVENTION group would have higher self-efficacy was adjusting for baseline self-efficacy scores.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.09</p_value>
            <method>Regression, Linear</method>
            <method_desc>adjusting for baseline Case scores.</method_desc>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>4.20</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.21</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Receiving Radiation Within 365 Days of Cancer Diagnosis</title>
        <description>The receipt of quality care is defined as receiving radiation to the breast within one year of a breast cancer diagnosis if: under the age of 70, estrogen or progesterone tumor positive and had breast conserving surgery.</description>
        <time_frame>Measured at 12 months</time_frame>
        <population>Excluded those women who did not meet requirements for receipt of radiation: over 70 years of age, with tumor negative for estrogen or progesterone</population>
        <group_list>
          <group group_id="O1">
            <title>Breast Cancer Intervention</title>
            <description>For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.</description>
          </group>
          <group group_id="O2">
            <title>Breast Cancer Control</title>
            <description>For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Receiving Radiation Within 365 Days of Cancer Diagnosis</title>
          <description>The receipt of quality care is defined as receiving radiation to the breast within one year of a breast cancer diagnosis if: under the age of 70, estrogen or progesterone tumor positive and had breast conserving surgery.</description>
          <population>Excluded those women who did not meet requirements for receipt of radiation: over 70 years of age, with tumor negative for estrogen or progesterone</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>We hypothesize that compared to the control group, the Breast cancer INTERVENTION group will receive quality care (i.e. receipt of radiation within one year of diagnosis).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.79</p_value>
            <p_value_desc>a priori threshold for statistical significance p&lt;0.05</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.28</ci_lower_limit>
            <ci_upper_limit>2.79</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distress Thermometer at 12 Months for BREAST Cancer Patients</title>
        <description>Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower values are more favorable</description>
        <time_frame>12 months after enrollment</time_frame>
        <population>The number of BREAST Intervention participants decreased by 22 for a total of 82 and Control participants decreased by 18 for a total of 75 due to missing Distress Thermometer data at 12 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Breast Cancer Intervention</title>
            <description>For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.</description>
          </group>
          <group group_id="O2">
            <title>Breast Cancer Control</title>
            <description>For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.</description>
          </group>
        </group_list>
        <measure>
          <title>Distress Thermometer at 12 Months for BREAST Cancer Patients</title>
          <description>Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower values are more favorable</description>
          <population>The number of BREAST Intervention participants decreased by 22 for a total of 82 and Control participants decreased by 18 for a total of 75 due to missing Distress Thermometer data at 12 months.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3" spread="3.5"/>
                    <measurement group_id="O2" value="5.3" spread="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>We hypothesize that compared to the control group, the Breast cancer INTERVENTION group will have less distress at 12 months post-enrollment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.71</p_value>
            <p_value_desc>a priori threshold for statistical significance p&lt;0.05</p_value_desc>
            <method>Regression, Linear</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>0.19</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.50</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distress Thermometer at 12 Months for LUNG Cancer Patients</title>
        <description>Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower scores are more favorable.</description>
        <time_frame>12 months after enrollment</time_frame>
        <population>The number of LUNG Intervention participants decreased by 3 for a total of 5. Control participants decreased by 6 for a total of 5 due to missing data at 12 months follow up.</population>
        <group_list>
          <group group_id="O1">
            <title>Lung Cancer Intervention</title>
            <description>For lung cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.</description>
          </group>
          <group group_id="O2">
            <title>Lung Cancer Control</title>
            <description>For lung cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.</description>
          </group>
        </group_list>
        <measure>
          <title>Distress Thermometer at 12 Months for LUNG Cancer Patients</title>
          <description>Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower scores are more favorable.</description>
          <population>The number of LUNG Intervention participants decreased by 3 for a total of 5. Control participants decreased by 6 for a total of 5 due to missing data at 12 months follow up.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="3.0"/>
                    <measurement group_id="O2" value="6.0" spread="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>We hypothesize that compared to the control group, the Lung cancer INTERVENTION group will have less distress at 12 months post-enrollment</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.61</p_value>
            <p_value_desc>a priori threshold for statistical significance p&lt;0.05</p_value_desc>
            <method>Regression, Linear</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-1.45</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>2.71</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cancer Needs and Distress Inventory at 12 Months for BREAST Cancer Patients</title>
        <description>Patient needs were assessed through patient interviews utilizing the Cancer Needs Distress Inventory (CaNDI) instrument. The CaNDI is a 38-item self-report instrument that rates need and distress level in the past two weeks using a 5 -point Likert scale where 1=not a problem to 5=very severe problem. The mean total score is reported.</description>
        <time_frame>12 months post-enrollment</time_frame>
        <population>The number of BREAST Intervention participants decreased by 23 for a total of 81. The Control participants decreased by 18 for a total of 75 due to missing CaNDI data at 12 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Breast Cancer Intervention</title>
            <description>For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.</description>
          </group>
          <group group_id="O2">
            <title>Breast Cancer Control</title>
            <description>For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.</description>
          </group>
        </group_list>
        <measure>
          <title>Cancer Needs and Distress Inventory at 12 Months for BREAST Cancer Patients</title>
          <description>Patient needs were assessed through patient interviews utilizing the Cancer Needs Distress Inventory (CaNDI) instrument. The CaNDI is a 38-item self-report instrument that rates need and distress level in the past two weeks using a 5 -point Likert scale where 1=not a problem to 5=very severe problem. The mean total score is reported.</description>
          <population>The number of BREAST Intervention participants decreased by 23 for a total of 81. The Control participants decreased by 18 for a total of 75 due to missing CaNDI data at 12 months.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.70" spread="0.70"/>
                    <measurement group_id="O2" value="1.70" spread="0.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.46</p_value>
            <p_value_desc>a priori threshold for statistical significance p&lt;0.05</p_value_desc>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.06</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.08</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cancer Needs and Distress Inventory at 12 Months for LUNG Cancer Patients</title>
        <description>Patient needs were assessed through patient interviews utilizing the Cancer Needs Distress Inventory (CaNDI) instrument. The CaNDI is a 38-item self-report instrument that rates need and distress level in the past two weeks using a 5 -point Likert scale where 1=not a problem to 5=very severe problem. The mean total score is reported.</description>
        <time_frame>12 months post-enrollment</time_frame>
        <population>The number of LUNG Intervention participants decreased by 3 for a total of 5. Control participants decreased by 6 for a total of 5 due to missing data at 12 months follow up.</population>
        <group_list>
          <group group_id="O1">
            <title>Lung Cancer Intervention</title>
            <description>Lung cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.</description>
          </group>
          <group group_id="O2">
            <title>Lung Cancer Control</title>
            <description>Lung cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.</description>
          </group>
        </group_list>
        <measure>
          <title>Cancer Needs and Distress Inventory at 12 Months for LUNG Cancer Patients</title>
          <description>Patient needs were assessed through patient interviews utilizing the Cancer Needs Distress Inventory (CaNDI) instrument. The CaNDI is a 38-item self-report instrument that rates need and distress level in the past two weeks using a 5 -point Likert scale where 1=not a problem to 5=very severe problem. The mean total score is reported.</description>
          <population>The number of LUNG Intervention participants decreased by 3 for a total of 5. Control participants decreased by 6 for a total of 5 due to missing data at 12 months follow up.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.50" spread="0.70"/>
                    <measurement group_id="O2" value="1.50" spread="0.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.89</p_value>
            <p_value_desc>a priori threshold for statistical significance p&lt;0.05</p_value_desc>
            <method>Regression, Linear</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-0.03</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.20</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction With Navigation at 12 Months Among BREAST Cancer Patients</title>
        <description>Patient's satisfaction assessed through the Patient Satisfaction with Interpersonal Relationship with Navigator Measure (PSN-1) questionnaire. Each question of the 9-item instrument has a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Responses are summed for a total score. The higher the score, the higher patient's satisfaction with navigation. The minimum value=9 and the maximum value=45. Higher scores are more favorable.</description>
        <time_frame>12 months post-enrollment</time_frame>
        <population>The number of BREAST Intervention participants decreased by 52 for a total of 52 and Control participants decreased by 55 for a total of 38 due to missing data at 12 months post-enrollment.</population>
        <group_list>
          <group group_id="O1">
            <title>Breast Cancer Intervention</title>
            <description>For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.</description>
          </group>
          <group group_id="O2">
            <title>Breast Cancer Control</title>
            <description>For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With Navigation at 12 Months Among BREAST Cancer Patients</title>
          <description>Patient's satisfaction assessed through the Patient Satisfaction with Interpersonal Relationship with Navigator Measure (PSN-1) questionnaire. Each question of the 9-item instrument has a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Responses are summed for a total score. The higher the score, the higher patient's satisfaction with navigation. The minimum value=9 and the maximum value=45. Higher scores are more favorable.</description>
          <population>The number of BREAST Intervention participants decreased by 52 for a total of 52 and Control participants decreased by 55 for a total of 38 due to missing data at 12 months post-enrollment.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.8" spread="6.9"/>
                    <measurement group_id="O2" value="38.4" spread="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.16</p_value>
            <p_value_desc>a priori threshold for statistical significance p&lt;0.05</p_value_desc>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>2.38</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.66</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction With Navigation at 12 Months Among LUNG Cancer Patients</title>
        <description>Patient's satisfaction assessed through the Patient Satisfaction with Interpersonal Relationship with Navigator Measure (PSN-1) questionnaire. Each question of the 9-item instrument has a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Responses are summed for a total score. The higher the score, the higher patient's satisfaction with navigation. The minimum value=9 and the maximum value=45. Higher scores are more favorable.</description>
        <time_frame>12 months post-enrollment</time_frame>
        <population>The number of Lung Intervention participants decrease by 5 for a total of 3 and the number of Lung Control participants decreased by 7 for a total of 4 due to missing data at 12 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Lung Cancer Intervention</title>
            <description>For lung cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.</description>
          </group>
          <group group_id="O2">
            <title>Lung Cancer Control</title>
            <description>For lung cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With Navigation at 12 Months Among LUNG Cancer Patients</title>
          <description>Patient's satisfaction assessed through the Patient Satisfaction with Interpersonal Relationship with Navigator Measure (PSN-1) questionnaire. Each question of the 9-item instrument has a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Responses are summed for a total score. The higher the score, the higher patient's satisfaction with navigation. The minimum value=9 and the maximum value=45. Higher scores are more favorable.</description>
          <population>The number of Lung Intervention participants decrease by 5 for a total of 3 and the number of Lung Control participants decreased by 7 for a total of 4 due to missing data at 12 months.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.7" spread="2.9"/>
                    <measurement group_id="O2" value="42.5" spread="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.16</p_value>
            <p_value_desc>a priori threshold for statistical significance p&lt;0.05</p_value_desc>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-4.83</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>2.93</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Self-efficacy for BREAST Cancer Patients at 12 Months</title>
        <description>Self-Efficacy will be assessed through patient interviews utilizing the Communication and Attitudinal Self-Efficacy (CASE). The CASE is a 12-item instrument that rates self-efficacy in three domains: (1) seeking and obtaining information, (2) understanding and participating in care, and (3) maintaining a positive attitude. A higher score indicates a positive attitude and strong self-efficacy. Total scores range from 12 to 48. A higher score is more favorable, indicating a positive attitude and strong self-efficacy.</description>
        <time_frame>12 months post-enrollment</time_frame>
        <population>The number of BREAST Intervention participants decreased by 23 for a total of 81 and for control participants by 19 for a total of 74 due to missing values at 12 months post-enrollment.</population>
        <group_list>
          <group group_id="O1">
            <title>Breast Cancer Intervention</title>
            <description>For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.</description>
          </group>
          <group group_id="O2">
            <title>Breast Cancer Control</title>
            <description>For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-efficacy for BREAST Cancer Patients at 12 Months</title>
          <description>Self-Efficacy will be assessed through patient interviews utilizing the Communication and Attitudinal Self-Efficacy (CASE). The CASE is a 12-item instrument that rates self-efficacy in three domains: (1) seeking and obtaining information, (2) understanding and participating in care, and (3) maintaining a positive attitude. A higher score indicates a positive attitude and strong self-efficacy. Total scores range from 12 to 48. A higher score is more favorable, indicating a positive attitude and strong self-efficacy.</description>
          <population>The number of BREAST Intervention participants decreased by 23 for a total of 81 and for control participants by 19 for a total of 74 due to missing values at 12 months post-enrollment.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.2" spread="4.5"/>
                    <measurement group_id="O2" value="43.0" spread="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.13</p_value>
            <p_value_desc>a priori threshold for statistical significance p&lt;0.05</p_value_desc>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.14</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.75</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Self-efficacy for LUNG Cancer Patients at 12 Months</title>
        <description>Self-Efficacy will be assessed through patient interviews utilizing the Communication and Attitudinal Self-Efficacy (CASE). The CASE is a 12-item instrument that rates self-efficacy in three domains: (1) seeking and obtaining information, (2) understanding and participating in care, and (3) maintaining a positive attitude. A higher score indicates a positive attitude and strong self-efficacy. Total scores range from 12 to 48. A higher score is more favorable, indicating a positive attitude and strong self-efficacy.</description>
        <time_frame>12 months post-enrollment</time_frame>
        <population>The number of Lung Intervention participants decrease by 3 for a total of 5 and the number of Lung Control participants decreased by 6 for a total of 5 due to missing data at 12 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Lung Cancer Intervention</title>
            <description>For lung cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.</description>
          </group>
          <group group_id="O2">
            <title>Lung Cancer Control</title>
            <description>For lung cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-efficacy for LUNG Cancer Patients at 12 Months</title>
          <description>Self-Efficacy will be assessed through patient interviews utilizing the Communication and Attitudinal Self-Efficacy (CASE). The CASE is a 12-item instrument that rates self-efficacy in three domains: (1) seeking and obtaining information, (2) understanding and participating in care, and (3) maintaining a positive attitude. A higher score indicates a positive attitude and strong self-efficacy. Total scores range from 12 to 48. A higher score is more favorable, indicating a positive attitude and strong self-efficacy.</description>
          <population>The number of Lung Intervention participants decrease by 3 for a total of 5 and the number of Lung Control participants decreased by 6 for a total of 5 due to missing data at 12 months.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.2" spread="4.8"/>
                    <measurement group_id="O2" value="43.6" spread="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.80</p_value>
            <p_value_desc>a priori threshold for statistical significance p&lt;0.05</p_value_desc>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.97</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>3.70</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Study enrollment began 2/1/2014 and ended 9/30/2018. Participants were assessed throughout their study participation to 1 year after enrollment.</time_frame>
      <desc>Involvement in this study has minimal risks. The main potential risk of this study is loss of confidentiality. As multiple safeguards were in place, including keeping files in a locked cabinets and only conducting data analysis on a data set that is coded and does not contain any direct identifiers.</desc>
      <group_list>
        <group group_id="E1">
          <title>Patient Navigation With Legal Support</title>
          <description>For those with legal concerns at baseline identified by the IHELP screening tool, intervention participants received Patient Navigation enhance with legal support.</description>
        </group>
        <group group_id="E2">
          <title>Standard Patient Navigation</title>
          <description>For those with legal concerns at baseline identified by the IHELP screening tool, control participants received standard of care Patient Navigation</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="107"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Tracy Battaglia</name_or_title>
      <organization>Boston Medical Center</organization>
      <phone>617.638.8036</phone>
      <email>tracy.battaglia@bmc.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02232074
org study id: H-32599
secondary id: RSG-13-368-01-CPPB
secondary id: AD-1304-6272
nct id: NCT02232074
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators plan to compare standard patient navigation with an enhanced navigation
      partnered with the Medical Legal Partnership | Boston (MLP) to determine if assessing legal
      needs of newly diagnosed cancer patients in addition to other barriers to care leads to
      better clinical outcomes.
Differences and delays in the delivery of cancer care lead to more advanced cancer at the
      time of diagnosis and ultimately to more deaths for low-income and minority communities. Our
      group helped develop a patient-navigation model using lay health workers to address patient
      barriers and coordinated cancer-care services, leading to more timely care. Despite the fact
      that patient navigation is now a standard required by the Commission on Cancer, the
      investigators' research shows that delays in care persist for our low-income patients with
      socio-legal barriers. Socio-legal barriers are defined as social problems related to meeting
      life's most basic needs that are supported by public policy or programming and thus
      potentially remedied through legal advocacy/action (e.g., unsafe/unstable housing, unlawful
      utility shutoffs, or job termination). Direct feedback from cancer patients suggests a
      critical need to address socio-legal barriers in order to achieve quality care for all. To
      expand the current impact of patient navigation on quality care for low-income patients, the
      investigators will partner with patients, key community stakeholders, and the Medical-Legal
      Partnership (MLP)|Boston, the founding site of a nationwide program assisting healthcare
      teams in addressing socio-legal barriers to health. Under direction from a Patient Advisory
      Group and a Community Advisory Board, the investigators will conduct a study to compare
      standard navigation with an MLP navigation intervention enhanced by legal support for
      low-income cancer patients.

      The investigators will enroll 374 low-income, racially diverse, newly diagnosed cancer
      patients. Half will receive standard navigation, i.e., a lay navigator integrated into the
      healthcare team who provides one-on-one patient contact to address traditional system
      barriers to care. The other half will receive MLP navigation, i.e., standard navigation
      enhanced by legal support including:

        1. a full socio-legal needs assessment and care plan in consultation with MLP; and

        2. legal assistance for eligible urgent legal needs. We will compare each group on all
           outcomes.

      Compared to standard navigation, we expect that addressing socio-legal barriers to care with
      MLP navigation will improve patient-reported outcomes and lead to more timely care delivery.
      Because of widespread national availability of patient navigation and MLP programs at
      hospitals serving vulnerable patients, this intervention can be quickly replicated to improve
      patient experience and survival.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Investigator, Outcomes Assessor)
measure: Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among BREAST Cancer Participants
time frame: Receipt of 1st treatment within 90 days from diagnosis
description: The receipt of timely care will be defined as initiation of care within 90 days, as this the shortest delay that has been shown to consistently affect mortality The time element was calculated from date of diagnosis (Time0) to date of treatment initiation (Time1) .The date chosen for the Time1 variable depends on the recommended care plan for each patient, as derived from the chart abstraction and based on patient presentation.
measure: Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among LUNG Cancer Participants
time frame: Receipt of 1st treatment within 90 days from diagnosis
description: The receipt of timely care will be defined as initiation of care within 90 days, as this the shortest delay that has been shown to consistently affect mortality The time element was calculated from date of diagnosis (Time0) to date of treatment initiation (Time1) .The date chosen for the Time1 variable depends on the recommended care plan for each patient, as derived from the chart abstraction and based on patient presentation.
measure: Distress Thermometer at 3 Months for BREAST Cancer Patients
time frame: 3 months after enrollment
description: Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower values are more favorable.
measure: Distress Thermometer at 3 Months for LUNG Cancer Patients
time frame: 3 months after enrollment
description: Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower values are more favorable.
measure: Distress Thermometer at 6 Months for BREAST Cancer Patients
time frame: 6 months after enrollment
description: Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower values are more favorable.
measure: Distress Thermometer at 6 Months for LUNG Cancer Patients
time frame: 6 months after enrollment
description: Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress).Lower values are more favorable.
measure: Cancer Needs and Distress Inventory at 6 Months for BREAST Cancer Patients
time frame: 6 months post-enrollment
description: Patient needs were assessed through patient interviews utilizing the Cancer Needs Distress Inventory (CaNDI) instrument. The CaNDI is a 38-item self-report instrument that rates need and distress level in the past two weeks using a 5 -point Likert scale where 1=not a problem to 5=very severe problem. For this analysis, the mean total score is reported with the minimum value=1 and the maximum value=4.10. Lower values are more favorable.
measure: Cancer Needs and Distress Inventory at 6 Months for LUNG Cancer Patients
time frame: 6 months post-enrollment
description: Patient needs were assessed through patient interviews utilizing the Cancer Needs Distress Inventory (CaNDI) instrument. The CaNDI is a 38-item self-report instrument that rates need and distress level in the past two weeks using a 5 -point Likert scale where 1=not a problem to 5=very severe problem. For this analysis, the mean total score is reported with the minimum value=1 and the maximum value=2.3. Lower values are more favorable.
measure: Patient Satisfaction With Navigation at 6 Months Among BREAST Cancer Patients
time frame: 6 months post-enrollment
description: Patient's satisfaction assessed through the Patient Satisfaction with Interpersonal Relationship with Navigator Measure (PSN-1) questionnaire. Each question of the 9-item instrument has a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Responses are summed for a total score. The higher the score, the higher patient's satisfaction with navigation. The minimum value=9 and the maximum value=45. Higher values are more favorable.
measure: Patient Satisfaction With Navigation at 6 Months Among LUNG Cancer Patients
time frame: 6 months post-enrollment
description: Patient's satisfaction assessed through the Patient Satisfaction with Interpersonal Relationship with Navigator Measure (PSN-1) questionnaire. Each question of the 9-item instrument has a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Responses are summed for a total score. The higher the score, the higher patient's satisfaction with navigation. The minimum value=9 and the maximum value=45. Higher values are more favorable.
measure: Self-efficacy for BREAST Cancer Patients at 6 Months
time frame: 6 months post-enrollment
description: Self-Efficacy will be assessed through patient interviews utilizing the Communication and Attitudinal Self-Efficacy (CASE). The CASE is a 12-item instrument that rates self-efficacy in three domains: (1) seeking and obtaining information, (2) understanding and participating in care, and (3) maintaining a positive attitude. Total scores range from 12 to 48. A higher score is more favorable, indicating a positive attitude and strong self-efficacy.
measure: Self-efficacy for LUNG Cancer Patients at 6 Months
time frame: 6 months post-enrollment
description: Self-Efficacy will be assessed through patient interviews utilizing the Communication and Attitudinal Self-Efficacy (CASE). The CASE is a 12-item instrument that rates self-efficacy in three domains: (1) seeking and obtaining information, (2) understanding and participating in care, and (3) maintaining a positive attitude. Total scores range from 12 to 48. A higher score is more favorable, indicating a positive attitude and strong self-efficacy.
measure: Number of Participants Receiving Radiation Within 365 Days of Cancer Diagnosis
time frame: Measured at 12 months
description: The receipt of quality care is defined as receiving radiation to the breast within one year of a breast cancer diagnosis if: under the age of 70, estrogen or progesterone tumor positive and had breast conserving surgery.
measure: Distress Thermometer at 12 Months for BREAST Cancer Patients
time frame: 12 months after enrollment
description: Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower values are more favorable
measure: Distress Thermometer at 12 Months for LUNG Cancer Patients
time frame: 12 months after enrollment
description: Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower scores are more favorable.
measure: Cancer Needs and Distress Inventory at 12 Months for BREAST Cancer Patients
time frame: 12 months post-enrollment
description: Patient needs were assessed through patient interviews utilizing the Cancer Needs Distress Inventory (CaNDI) instrument. The CaNDI is a 38-item self-report instrument that rates need and distress level in the past two weeks using a 5 -point Likert scale where 1=not a problem to 5=very severe problem. The mean total score is reported.
measure: Cancer Needs and Distress Inventory at 12 Months for LUNG Cancer Patients
time frame: 12 months post-enrollment
description: Patient needs were assessed through patient interviews utilizing the Cancer Needs Distress Inventory (CaNDI) instrument. The CaNDI is a 38-item self-report instrument that rates need and distress level in the past two weeks using a 5 -point Likert scale where 1=not a problem to 5=very severe problem. The mean total score is reported.
measure: Patient Satisfaction With Navigation at 12 Months Among BREAST Cancer Patients
time frame: 12 months post-enrollment
description: Patient's satisfaction assessed through the Patient Satisfaction with Interpersonal Relationship with Navigator Measure (PSN-1) questionnaire. Each question of the 9-item instrument has a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Responses are summed for a total score. The higher the score, the higher patient's satisfaction with navigation. The minimum value=9 and the maximum value=45. Higher scores are more favorable.
measure: Patient Satisfaction With Navigation at 12 Months Among LUNG Cancer Patients
time frame: 12 months post-enrollment
description: Patient's satisfaction assessed through the Patient Satisfaction with Interpersonal Relationship with Navigator Measure (PSN-1) questionnaire. Each question of the 9-item instrument has a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Responses are summed for a total score. The higher the score, the higher patient's satisfaction with navigation. The minimum value=9 and the maximum value=45. Higher scores are more favorable.
measure: Self-efficacy for BREAST Cancer Patients at 12 Months
time frame: 12 months post-enrollment
description: Self-Efficacy will be assessed through patient interviews utilizing the Communication and Attitudinal Self-Efficacy (CASE). The CASE is a 12-item instrument that rates self-efficacy in three domains: (1) seeking and obtaining information, (2) understanding and participating in care, and (3) maintaining a positive attitude. A higher score indicates a positive attitude and strong self-efficacy. Total scores range from 12 to 48. A higher score is more favorable, indicating a positive attitude and strong self-efficacy.
measure: Self-efficacy for LUNG Cancer Patients at 12 Months
time frame: 12 months post-enrollment
description: Self-Efficacy will be assessed through patient interviews utilizing the Communication and Attitudinal Self-Efficacy (CASE). The CASE is a 12-item instrument that rates self-efficacy in three domains: (1) seeking and obtaining information, (2) understanding and participating in care, and (3) maintaining a positive attitude. A higher score indicates a positive attitude and strong self-efficacy. Total scores range from 12 to 48. A higher score is more favorable, indicating a positive attitude and strong self-efficacy.
arm group label: Patient navigation enhanced with legal support
arm group type: Experimental
description: In addition to receiving standard navigation, patients will be connected with a Patient Navigator who is partnered with a lawyer from Medical-Legal Partnership to provide personalized assistance with regard to social-legal barriers.
arm group label: Standard patient navigation
arm group type: No Intervention
description: These patients will receive standard patient navigation which will work to ensure that services are coordinated amongst medical personnel, while also addressing patients' needs.
intervention type: Other
intervention name: Patient navigation enhanced with legal support
arm group label: Patient navigation enhanced with legal support
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tracy A Battaglia, M.D., M.P.H
role: Principal Investigator
affiliation: Boston Medical Center
last name: Sharon Bak, M.P.H
role: Study Director
affiliation: Boston Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Medical Center
investigator full name: Battaglia, Tracy
investigator title: Associate Professor of Medicine and Epidemiology, Boston University School of Medicine, Chief of Women's Health Unit
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 