<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/NCT03016403</url>
  </required_header>
  <id_info>
    <org_study_id>16-2621.cc</org_study_id>
    <secondary_id>AD-1511-33395</secondary_id>
    <nct_id>NCT03016403</nct_id>
  </id_info>
  <brief_title>A Stepped Care Intervention to Reduce Disparities in Mental Health Services Among Cancer Patients and Caregivers</brief_title>
  <official_title>A Stepped-Care Intervention to Reduce Disparities in Mental Health Services Among Underserved Lung and Head and Neck Cancer Patients and Their Caregivers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Medically under-served (i.e., low-income, uninsured, underinsured) cancer patients generally&#xD;
      encounter significant disparities in accessing care for their mental health needs while&#xD;
      undergoing toxic treatments that provide considerable physical and emotional stress. Thus,&#xD;
      the investigators propose to adapt evidence-based strategies to a stepped-care intervention&#xD;
      model to address the mental health needs of under-served lung cancer (LC) and head and neck&#xD;
      cancer (HNC) patients and their caregivers across several levels of symptom severity (e.g.,&#xD;
      mild, moderate, or severe symptoms of depression and anxiety).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 3, 2017</start_date>
  <completion_date type="Actual">July 17, 2020</completion_date>
  <primary_completion_date type="Actual">July 17, 2020</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Symptoms of Depression-Patients</measure>
    <time_frame>6-months</time_frame>
    <description>Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer (CA) Form v1.0 - Depression (30 items). The range is from 8 to 40. Higher score indicates worse outcome (higher depression). Raw scores were used in analyses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptoms of Anxiety-Patients</measure>
    <time_frame>6-months</time_frame>
    <description>Patient-Reported Outcomes Measurement Information System, Anxiety (PROMIS-Ca) Form v1.0- Anxiety (22 items). The range of scores is between 8 and 40. The raw scores were used. Higher score corresponds to worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Coping-Patients</measure>
    <time_frame>6-months</time_frame>
    <description>Coping Self-Efficacy (26 items). Scores can rage from 0 to 260. Higher score corresponds to better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Coping-Caregivers</measure>
    <time_frame>6-months</time_frame>
    <description>Coping Self-Efficacy (26 items). Higher score corresponds to better outcome. Scores can rage from 0 to 260.&#xD;
The number of caregivers randomized and analyzed was 118 and 131 in the enhanced usual care and intervention groups, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms of Anxiety-Caregivers</measure>
    <time_frame>6-months</time_frame>
    <description>PROMIS Form v1.0 - Anxiety (29 items). The range of scores is from 8 to 40. Higher score indicates worse outcome (higher anxiety). Raw scores were used in analyses.&#xD;
The number of caregivers randomized and analyzed was 118 and 131 in the enhanced usual care and intervention groups, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms of Depression-Caregivers</measure>
    <time_frame>6-months</time_frame>
    <description>PROMIS Form v1.0 - Depression (28 items). The range is from 8 to 40. Higher score indicates worse outcome (higher depression). Raw scores were used in analyses.&#xD;
The number of caregivers randomized and analyzed was 118 and 131 in the enhanced usual care and intervention groups, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-Related Quality of Life-Patients</measure>
    <time_frame>6-months</time_frame>
    <description>FACT-G version 4 (27 items). The range is 0-108. Higher values indicate better QOL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress-Patients</measure>
    <time_frame>6-months</time_frame>
    <description>Perceived Stress Scale (PSS) (14 items). The range of scores is 0-40. Higher values indicate higher stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress-Caregivers</measure>
    <time_frame>6-months</time_frame>
    <description>Perceived Stress Scale (PSS) (14 items). The range is from 0 to 40. Higher values indicate higher stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiving Burden-Caregivers</measure>
    <time_frame>6-months</time_frame>
    <description>Zarit Burden Interview (ZBI) (12 items). The range of scores is 0-48. Higher scores represent higher burden.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">535</enrollment>
  <condition>Cancer, Lung</condition>
  <condition>Cancer, Head and Neck</condition>
  <arm_group>
    <arm_group_label>Stepped-Care Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention strategies are grounded in evidence-based Cognitive Behavioral Therapy (CBT), that includes stress management and relaxation treatment strategies and coping skills training. Treatment strategies have been adapted from the Transactional Model of Stress and Coping (TMSC), a theoretical model that predicts that individuals who are able to cope and adapt to the stress related to cancer treatment or caregiving will report less psychological distress than those unable to cope.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Denver Health, St. Mary's and St. Joseph's hospitals provide supportive mental health care for patients such as printed materials, support groups, crisis counseling, and specialized care (e.g., psychiatric medication). Because the amount of usual mental health care that each patient receives varies at each site, the investigators will standardize and monitor the usual care arm across the three sites with an enhanced usual care condition.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Stepped-Care Intervention</intervention_name>
    <description>The intervention delivered evidence-based CBT and stress management across eight counseling sessions.</description>
    <arm_group_label>Stepped-Care Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced Usual Care</intervention_name>
    <description>Consists of a list of standard mental health resources offered at the participating hospital, local community, or national non-profit organizations.</description>
    <arm_group_label>Enhanced Usual Care</arm_group_label>
    <other_name>Standard of Care</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        1. LC and HNC patients:&#xD;
&#xD;
             Inclusion Criteria:&#xD;
&#xD;
               -  Newly diagnosed LC and/or HNC (within a month of recruitment date from the date&#xD;
                  of 1st visit oncology, Ear Nose and Throat (ENT), or radiation clinic&#xD;
                  visit/consultation upon pathologic tissue diagnosis;&#xD;
&#xD;
               -  LC and/or HNC patients at any stage of diagnosis (Stages 0-IV);&#xD;
&#xD;
               -  Over 18 years old;&#xD;
&#xD;
               -  English and/or Spanish speaking;&#xD;
&#xD;
               -  Medically underserved, as defined by at least one or several of the following:&#xD;
&#xD;
                    1. Low-income: Below 400% of the 2016 Federal poverty levels;&#xD;
&#xD;
                    2. Uninsured: No health insurance (public or private insurance);&#xD;
&#xD;
                    3. Underinsured: e.g.: Public insurance (Medicaid, Medicare exclusive, VA);&#xD;
                       and/or 10% of annual income on out-of-pocket medical expenses for&#xD;
                       individuals below 200% of the 2016 Federal poverty levels.&#xD;
&#xD;
             Exclusion Criteria:&#xD;
&#xD;
               -  Individuals who do not meet eligibility criteria, including individuals who do&#xD;
                  not speak English or Spanish;&#xD;
&#xD;
               -  Those who refuse treatment at one of three hospital sites;&#xD;
&#xD;
               -  Decisionally-challenged adults with cognitive or personality impairment;&#xD;
&#xD;
               -  Suicidal ideation, or&#xD;
&#xD;
               -  Intoxication (alcohol or drugs) that might interfere with their ability to&#xD;
                  consent or participate in the study;&#xD;
&#xD;
               -  Individuals from vulnerable populations (e.g., inmates or individuals on&#xD;
                  probation,&#xD;
&#xD;
               -  homeless,&#xD;
&#xD;
               -  pregnant women, and&#xD;
&#xD;
               -  those with auditory impairment.&#xD;
&#xD;
             Note: Individuals who become pregnant or develop auditory impairments after they have&#xD;
             been randomized to study condition may remain in the study until completion.&#xD;
&#xD;
          2. Caregivers of LC and/or HNC patients&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary caregiver of a newly diagnosed LC and/or HNC patient (per criteria for&#xD;
             patients);&#xD;
&#xD;
          -  Over 18 years old;&#xD;
&#xD;
          -  English and/or Spanish speaking;&#xD;
&#xD;
          -  Medically underserved, as defined by at least one or several of the following:&#xD;
&#xD;
               1. Low-income: Below 400% of the 2016 Federal poverty levels;&#xD;
&#xD;
               2. Uninsured: No health insurance (public or private insurance);&#xD;
&#xD;
               3. Underinsured:&#xD;
&#xD;
          -  (c.1) Public insurance (i.e., Medicaid, Medicare exclusive, VA);&#xD;
&#xD;
          -  (c.2) 10% of annual income spent on out-of-pocket medical expenses for individuals&#xD;
             below 200% of the 2016 Federal poverty level.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Individuals who do not meet eligibility criteria, including individuals who do not&#xD;
             speak English or Spanish [at the discretion of the Site Coordinators upon&#xD;
             recruitment];&#xD;
&#xD;
          -  Caregivers of patients who refuse treatment at one of three hospital sites.&#xD;
&#xD;
          -  Decisionally challenged adults with:&#xD;
&#xD;
               1. cognitive or personality impairment,&#xD;
&#xD;
               2. suicidal ideation, or&#xD;
&#xD;
               3. intoxication (alcohol or drugs) that might interfere with their ability to&#xD;
                  consent or participate in the study [at the discretion of the Site Coordinators&#xD;
                  upon recruitment or the Counselor during the intervention];&#xD;
&#xD;
          -  Individuals from:&#xD;
&#xD;
               1. vulnerable populations (e.g., inmates or individuals on probation, homeless,&#xD;
&#xD;
               2. pregnant women, and&#xD;
&#xD;
               3. those with auditory impairment [at the discretion of the Site Coordinators upon&#xD;
                  recruitment]).&#xD;
&#xD;
               4. Individuals who become pregnant or develop auditory impairments after they have&#xD;
                  been randomized to study condition may remain in the study until completion.&#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>Evelinn A Borrayo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Denver Health Medical Center</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Denver</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Jewish Health</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Hospital</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Mary's Hospital and Regional Medical Center</name>
      <address>
        <city>Grand Junction</city>
        <state>Colorado</state>
        <zip>81502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <results_first_submitted>November 2, 2020</results_first_submitted>
  <results_first_submitted_qc>February 24, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 19, 2021</results_first_posted>
  <last_update_submitted>February 24, 2021</last_update_submitted>
  <last_update_submitted_qc>February 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Head and Neck Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 30, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT03016403/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 30, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT03016403/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Both patients and caregivers were recruited for this study. Primary outcomes data were focused on patients. Caregiver data were included as secondary analyses.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Patients in Enhanced Usual Care</title>
          <description>Patients who were randomized to Enhanced Usual Care</description>
        </group>
        <group group_id="P2">
          <title>Patients in Stepped Care Intervention</title>
          <description>Patients who were randomized to the Stepped Care Intervention</description>
        </group>
        <group group_id="P3">
          <title>Caregivers in Enhanced Usual Care</title>
          <description>Caregivers who were randomized into Enhanced Usual Care</description>
        </group>
        <group group_id="P4">
          <title>Caregivers in Stepped Care Intervention</title>
          <description>Caregivers who were randomized to the Stepped Care Intervention</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Baseline</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="139"/>
                <participants group_id="P2" count="147"/>
                <participants group_id="P3" count="118"/>
                <participants group_id="P4" count="131"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="123"/>
                <participants group_id="P2" count="120"/>
                <participants group_id="P3" count="107"/>
                <participants group_id="P4" count="97"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="27"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="34"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="24"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>6-week Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="123">Anyone who had at least 1 follow-up after baseline.</participants>
                <participants group_id="P2" count="120"/>
                <participants group_id="P3" count="107"/>
                <participants group_id="P4" count="97"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="120"/>
                <participants group_id="P2" count="107"/>
                <participants group_id="P3" count="103"/>
                <participants group_id="P4" count="88"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>3-month Follow-up and 6-month Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="120"/>
                <participants group_id="P2" count="107"/>
                <participants group_id="P3" count="103"/>
                <participants group_id="P4" count="88"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="108"/>
                <participants group_id="P2" count="96"/>
                <participants group_id="P3" count="95"/>
                <participants group_id="P4" count="81"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Patients in Enhanced Usual Care</title>
          <description>Patients who were randomized to Enhanced Usual Care</description>
        </group>
        <group group_id="B2">
          <title>Patients in Stepped Care Intervention</title>
          <description>Patients who were randomized to the Stepped Care Intervention</description>
        </group>
        <group group_id="B3">
          <title>Caregivers in Enhanced Usual Care</title>
          <description>Caregivers who were randomized to Enhanced Usual Care</description>
        </group>
        <group group_id="B4">
          <title>Caregivers in Stepped Care Intervention</title>
          <description>Caregivers who were randomized to the Stepped Care Intervention</description>
        </group>
        <group group_id="B5">
          <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="139"/>
            <count group_id="B2" value="147"/>
            <count group_id="B3" value="118"/>
            <count group_id="B4" value="131"/>
            <count group_id="B5" value="535"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="139"/>
                    <count group_id="B2" value="147"/>
                    <count group_id="B3" value="118"/>
                    <count group_id="B4" value="131"/>
                    <count group_id="B5" value="535"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Under 18</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>18 to 65</title>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="64"/>
                    <measurement group_id="B4" value="69"/>
                    <measurement group_id="B5" value="267"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Above 65</title>
                  <measurement_list>
                    <measurement group_id="B1" value="74"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="36"/>
                    <measurement group_id="B5" value="221"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Report</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="26"/>
                    <measurement group_id="B5" value="47"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="139"/>
                    <count group_id="B2" value="147"/>
                    <count group_id="B3" value="118"/>
                    <count group_id="B4" value="131"/>
                    <count group_id="B5" value="535"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="92"/>
                    <measurement group_id="B4" value="99"/>
                    <measurement group_id="B5" value="310"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="82"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="32"/>
                    <measurement group_id="B5" value="225"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="139"/>
                    <count group_id="B2" value="147"/>
                    <count group_id="B3" value="118"/>
                    <count group_id="B4" value="131"/>
                    <count group_id="B5" value="535"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="37"/>
                    <measurement group_id="B5" value="126"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="112"/>
                    <measurement group_id="B2" value="113"/>
                    <measurement group_id="B3" value="89"/>
                    <measurement group_id="B4" value="94"/>
                    <measurement group_id="B5" value="408"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="139"/>
                    <count group_id="B2" value="147"/>
                    <count group_id="B3" value="118"/>
                    <count group_id="B4" value="131"/>
                    <count group_id="B5" value="535"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="123"/>
                    <measurement group_id="B2" value="122"/>
                    <measurement group_id="B3" value="99"/>
                    <measurement group_id="B4" value="107"/>
                    <measurement group_id="B5" value="451"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="139"/>
                    <count group_id="B2" value="147"/>
                    <count group_id="B3" value="118"/>
                    <count group_id="B4" value="131"/>
                    <count group_id="B5" value="535"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="139"/>
                    <measurement group_id="B2" value="147"/>
                    <measurement group_id="B3" value="118"/>
                    <measurement group_id="B4" value="131"/>
                    <measurement group_id="B5" value="286"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Language Preference</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="139"/>
                    <count group_id="B2" value="147"/>
                    <count group_id="B3" value="118"/>
                    <count group_id="B4" value="131"/>
                    <count group_id="B5" value="535"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>English</title>
                  <measurement_list>
                    <measurement group_id="B1" value="133"/>
                    <measurement group_id="B2" value="132"/>
                    <measurement group_id="B3" value="111"/>
                    <measurement group_id="B4" value="118"/>
                    <measurement group_id="B5" value="494"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Spanish</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diagnosis</title>
          <population>Diagnosis data were not collected from caregivers.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="139"/>
                    <count group_id="B2" value="147"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Head and neck cancer</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="120"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Lung cancer</title>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                    <measurement group_id="B2" value="87"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="166"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cancer Stage</title>
          <description>Cancer Stage were clinically diagnosed by medical oncologists at each site and were self-reported by patients in the baseline survey. The cancer stages varied between stage 0, I, II, III, and IV with IV being the most advanced.</description>
          <population>No cancer stage was collected from the caregivers.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="139"/>
                    <count group_id="B2" value="147"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Stage 0, I, &amp; II</title>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="132"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Stage III &amp; IV</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="151"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Step at Baseline</title>
          <description>The treatment steps that participants were assigned to, based on their personal level of distress included:&#xD;
Step 1: Watchful Waiting Step 2: Self-Help Guide Step 3: Coping Skills Training Step 4: Cognitive-Behavioral Therapy</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="139"/>
                    <count group_id="B2" value="147"/>
                    <count group_id="B3" value="118"/>
                    <count group_id="B4" value="131"/>
                    <count group_id="B5" value="535"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Step 1 &amp; 2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="106"/>
                    <measurement group_id="B2" value="114"/>
                    <measurement group_id="B3" value="89"/>
                    <measurement group_id="B4" value="106"/>
                    <measurement group_id="B5" value="415"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Step 3 &amp; 4</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="29"/>
                    <measurement group_id="B4" value="25"/>
                    <measurement group_id="B5" value="119"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Symptoms of Depression-Patients</title>
        <description>Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer (CA) Form v1.0 - Depression (30 items). The range is from 8 to 40. Higher score indicates worse outcome (higher depression). Raw scores were used in analyses.</description>
        <time_frame>6-months</time_frame>
        <population>Intention to treat population- all participants who were randomized were included in this analysis. The reported means correspond to the observed means at 6 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Patients in Enhanced Usual Care</title>
            <description>Patients who were randomized to Enhanced Usual Care</description>
          </group>
          <group group_id="O2">
            <title>Patients in Stepped Care Intervention</title>
            <description>Patients who were randomized to the Stepped Care Intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Symptoms of Depression-Patients</title>
          <description>Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer (CA) Form v1.0 - Depression (30 items). The range is from 8 to 40. Higher score indicates worse outcome (higher depression). Raw scores were used in analyses.</description>
          <population>Intention to treat population- all participants who were randomized were included in this analysis. The reported means correspond to the observed means at 6 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="139"/>
                <count group_id="O2" value="147"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.3" spread="7.0"/>
                    <measurement group_id="O2" value="13.2" spread="5.7"/>
                  </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>A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0057</p_value>
            <p_value_desc>Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.52</ci_lower_limit>
            <ci_upper_limit>2.98</ci_upper_limit>
            <estimate_desc>The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Symptoms of Anxiety-Patients</title>
        <description>Patient-Reported Outcomes Measurement Information System, Anxiety (PROMIS-Ca) Form v1.0- Anxiety (22 items). The range of scores is between 8 and 40. The raw scores were used. Higher score corresponds to worse outcome.</description>
        <time_frame>6-months</time_frame>
        <population>Intention to treat population.</population>
        <group_list>
          <group group_id="O1">
            <title>Enhanced Usual Care</title>
            <description>Enhanced Usual Care: Consists of a list of standard mental health resources offered at the participating hospital, local community, or national non-profit organizations.</description>
          </group>
          <group group_id="O2">
            <title>Stepped-Care Intervention</title>
            <description>Intervention strategies are grounded in evidence-based Cognitive Behavioral Therapy (CBT), that includes stress management and relaxation treatment strategies and coping skills training. Treatment strategies have been adapted from the Transactional Model of Stress and Coping (TMSC), a theoretical model that predicts that individuals who are able to cope and adapt to the stress related to cancer treatment or caregiving will report less psychological distress than those unable to cope.&#xD;
Stepped-Care Intervention: The intervention delivered evidence-based CBT and stress management across eight counseling sessions.</description>
          </group>
        </group_list>
        <measure>
          <title>Symptoms of Anxiety-Patients</title>
          <description>Patient-Reported Outcomes Measurement Information System, Anxiety (PROMIS-Ca) Form v1.0- Anxiety (22 items). The range of scores is between 8 and 40. The raw scores were used. Higher score corresponds to worse outcome.</description>
          <population>Intention to treat population.</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="139"/>
                <count group_id="O2" value="147"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.0" spread="7.0"/>
                    <measurement group_id="O2" value="13.9" spread="6.6"/>
                  </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>Linear mixed models (LMM) have been used with time and the interaction between time and group as fixed effects. A structure of random effects that includes random intercepts for patients was used. The study was powered for testing the hypothesis of no group differences in change over the four time points. A significant group by time interaction was hypothesized.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0243</p_value>
            <p_value_desc>Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.46</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.19</ci_lower_limit>
            <ci_upper_limit>2.73</ci_upper_limit>
            <estimate_desc>The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Coping-Patients</title>
        <description>Coping Self-Efficacy (26 items). Scores can rage from 0 to 260. Higher score corresponds to better outcome.</description>
        <time_frame>6-months</time_frame>
        <population>Intention to treat population.</population>
        <group_list>
          <group group_id="O1">
            <title>Enhanced Usual Care</title>
            <description>Enhanced Usual Care: Consists of a list of standard mental health resources offered at the participating hospital, local community, or national non-profit organizations.</description>
          </group>
          <group group_id="O2">
            <title>Stepped-Care Intervention</title>
            <description>Intervention strategies are grounded in evidence-based Cognitive Behavioral Therapy (CBT), that includes stress management and relaxation treatment strategies and coping skills training. Treatment strategies have been adapted from the Transactional Model of Stress and Coping (TMSC), a theoretical model that predicts that individuals who are able to cope and adapt to the stress related to cancer treatment or caregiving will report less psychological distress than those unable to cope.&#xD;
Stepped-Care Intervention: The intervention delivered evidence-based CBT and stress management across eight counseling sessions.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Coping-Patients</title>
          <description>Coping Self-Efficacy (26 items). Scores can rage from 0 to 260. Higher score corresponds to better outcome.</description>
          <population>Intention to treat population.</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="139"/>
                <count group_id="O2" value="147"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="190" spread="55"/>
                    <measurement group_id="O2" value="207" spread="54"/>
                  </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>Linear mixed models (LMM) have been used with time and the interaction between time and group as fixed effects. A structure of random effects that includes random intercepts for patients was used. The study was powered for testing the hypothesis of no group differences in change over the four time points. A significant group by time interaction was hypothesized.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0061</p_value>
            <p_value_desc>Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>The pvalue corresponds to the hypothesis of an interaction between time and intervention arm.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-15.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-26.23</ci_lower_limit>
            <ci_upper_limit>-4.39</ci_upper_limit>
            <estimate_desc>The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Coping-Caregivers</title>
        <description>Coping Self-Efficacy (26 items). Higher score corresponds to better outcome. Scores can rage from 0 to 260.&#xD;
The number of caregivers randomized and analyzed was 118 and 131 in the enhanced usual care and intervention groups, respectively.</description>
        <time_frame>6-months</time_frame>
        <population>Intention to treat population.</population>
        <group_list>
          <group group_id="O1">
            <title>Enhanced Usual Care</title>
            <description>Enhanced Usual Care: Consists of a list of standard mental health resources offered at the participating hospital, local community, or national non-profit organizations.</description>
          </group>
          <group group_id="O2">
            <title>Stepped-Care Intervention</title>
            <description>Intervention strategies are grounded in evidence-based Cognitive Behavioral Therapy (CBT), that includes stress management and relaxation treatment strategies and coping skills training. Treatment strategies have been adapted from the Transactional Model of Stress and Coping (TMSC), a theoretical model that predicts that individuals who are able to cope and adapt to the stress related to cancer treatment or caregiving will report less psychological distress than those unable to cope.&#xD;
Stepped-Care Intervention: The intervention delivered evidence-based CBT and stress management across eight counseling sessions.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Coping-Caregivers</title>
          <description>Coping Self-Efficacy (26 items). Higher score corresponds to better outcome. Scores can rage from 0 to 260.&#xD;
The number of caregivers randomized and analyzed was 118 and 131 in the enhanced usual care and intervention groups, respectively.</description>
          <population>Intention to treat population.</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="118"/>
                <count group_id="O2" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="192" spread="52"/>
                    <measurement group_id="O2" value="211" spread="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>
            <groups_desc>A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.21</p_value>
            <p_value_desc>Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-7.73</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-19.73</ci_lower_limit>
            <ci_upper_limit>4.27</ci_upper_limit>
            <estimate_desc>The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Symptoms of Anxiety-Caregivers</title>
        <description>PROMIS Form v1.0 - Anxiety (29 items). The range of scores is from 8 to 40. Higher score indicates worse outcome (higher anxiety). Raw scores were used in analyses.&#xD;
The number of caregivers randomized and analyzed was 118 and 131 in the enhanced usual care and intervention groups, respectively.</description>
        <time_frame>6-months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Caregivers in Enhanced Usual Care</title>
            <description>Caregivers who were randomized to Enhanced Usual Care</description>
          </group>
          <group group_id="O2">
            <title>Caregivers in Stepped Care Intervention</title>
            <description>Caregivers who were randomized to the Stepped Care Intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Symptoms of Anxiety-Caregivers</title>
          <description>PROMIS Form v1.0 - Anxiety (29 items). The range of scores is from 8 to 40. Higher score indicates worse outcome (higher anxiety). Raw scores were used in analyses.&#xD;
The number of caregivers randomized and analyzed was 118 and 131 in the enhanced usual care and intervention groups, respectively.</description>
          <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="118"/>
                <count group_id="O2" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17" spread="7"/>
                    <measurement group_id="O2" value="14" spread="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>A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.052</p_value>
            <p_value_desc>Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.52</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.01</ci_lower_limit>
            <ci_upper_limit>3.05</ci_upper_limit>
            <estimate_desc>The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Symptoms of Depression-Caregivers</title>
        <description>PROMIS Form v1.0 - Depression (28 items). The range is from 8 to 40. Higher score indicates worse outcome (higher depression). Raw scores were used in analyses.&#xD;
The number of caregivers randomized and analyzed was 118 and 131 in the enhanced usual care and intervention groups, respectively.</description>
        <time_frame>6-months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Caregivers in Enhanced Usual Care</title>
            <description>Caregivers who were randomized to Enhanced Usual Care</description>
          </group>
          <group group_id="O2">
            <title>Caregivers in Stepped Care Intervention</title>
            <description>Caregivers who were randomized to the Stepped Care Intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Symptoms of Depression-Caregivers</title>
          <description>PROMIS Form v1.0 - Depression (28 items). The range is from 8 to 40. Higher score indicates worse outcome (higher depression). Raw scores were used in analyses.&#xD;
The number of caregivers randomized and analyzed was 118 and 131 in the enhanced usual care and intervention groups, respectively.</description>
          <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="118"/>
                <count group_id="O2" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" spread="6.9"/>
                    <measurement group_id="O2" value="13.2" spread="5.7"/>
                  </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>A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.214</p_value>
            <p_value_desc>Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.91</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.52</ci_lower_limit>
            <ci_upper_limit>2.36</ci_upper_limit>
            <estimate_desc>The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Health-Related Quality of Life-Patients</title>
        <description>FACT-G version 4 (27 items). The range is 0-108. Higher values indicate better QOL.</description>
        <time_frame>6-months</time_frame>
        <population>Intention to treat population.</population>
        <group_list>
          <group group_id="O1">
            <title>Patients in Enhanced Usual Care</title>
            <description>Patients who were randomized to Enhanced Usual Care</description>
          </group>
          <group group_id="O2">
            <title>Patients in Stepped Care Intervention</title>
            <description>Patients who were randomized to the Stepped Care Intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Health-Related Quality of Life-Patients</title>
          <description>FACT-G version 4 (27 items). The range is 0-108. Higher values indicate better QOL.</description>
          <population>Intention to treat population.</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="139"/>
                <count group_id="O2" value="147"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73" spread="19"/>
                    <measurement group_id="O2" value="80" spread="19"/>
                  </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>A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0134</p_value>
            <p_value_desc>Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-4.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.45</ci_lower_limit>
            <ci_upper_limit>-0.87</ci_upper_limit>
            <estimate_desc>The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Perceived Stress-Patients</title>
        <description>Perceived Stress Scale (PSS) (14 items). The range of scores is 0-40. Higher values indicate higher stress.</description>
        <time_frame>6-months</time_frame>
        <population>intention to treat population</population>
        <group_list>
          <group group_id="O1">
            <title>Patients in Enhanced Usual Care</title>
            <description>Patients who were randomized to Enhanced Usual Care</description>
          </group>
          <group group_id="O2">
            <title>Patients in Stepped Care Intervention</title>
            <description>Patients who were randomized to the Stepped Care Intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Perceived Stress-Patients</title>
          <description>Perceived Stress Scale (PSS) (14 items). The range of scores is 0-40. Higher values indicate higher stress.</description>
          <population>intention to treat population</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="139"/>
                <count group_id="O2" value="147"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14" spread="7"/>
                    <measurement group_id="O2" value="13" spread="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>A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.42</p_value>
            <p_value_desc>Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.61</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.9</ci_lower_limit>
            <ci_upper_limit>2.12</ci_upper_limit>
            <estimate_desc>The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Perceived Stress-Caregivers</title>
        <description>Perceived Stress Scale (PSS) (14 items). The range is from 0 to 40. Higher values indicate higher stress.</description>
        <time_frame>6-months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Caregivers in Enhanced Usual Care</title>
            <description>Caregivers who were randomized to Enhanced Usual Care</description>
          </group>
          <group group_id="O2">
            <title>Caregivers in Stepped Care Intervention</title>
            <description>Caregivers who were randomized to the Stepped Care Intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Perceived Stress-Caregivers</title>
          <description>Perceived Stress Scale (PSS) (14 items). The range is from 0 to 40. Higher values indicate higher stress.</description>
          <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="118"/>
                <count group_id="O2" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15" spread="7"/>
                    <measurement group_id="O2" value="11" spread="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>A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0269</p_value>
            <p_value_desc>Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.2</ci_lower_limit>
            <ci_upper_limit>3.34</ci_upper_limit>
            <estimate_desc>The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Caregiving Burden-Caregivers</title>
        <description>Zarit Burden Interview (ZBI) (12 items). The range of scores is 0-48. Higher scores represent higher burden.</description>
        <time_frame>6-months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Caregivers in Enhanced Usual Care</title>
            <description>Caregivers who were randomized to Enhanced Usual Care</description>
          </group>
          <group group_id="O2">
            <title>Caregivers in Stepped Care Intervention</title>
            <description>Caregivers who were randomized to the Stepped Care Intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Caregiving Burden-Caregivers</title>
          <description>Zarit Burden Interview (ZBI) (12 items). The range of scores is 0-48. Higher scores represent higher burden.</description>
          <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="118"/>
                <count group_id="O2" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13" spread="9"/>
                    <measurement group_id="O2" value="9" spread="8"/>
                  </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>A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0044</p_value>
            <p_value_desc>Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>2.56</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.8</ci_lower_limit>
            <ci_upper_limit>4.32</ci_upper_limit>
            <estimate_desc>The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Between baseline through the six month follow-up. Adverse events can be reported by the study coordinators at anytime from baseline through completion of the 6 month follow-up.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Patients in Enhanced Usual Care</title>
          <description>Patients who were randomized to Enhanced Usual Care</description>
        </group>
        <group group_id="E2">
          <title>Patients in Stepped Care Intervention</title>
          <description>Patients who were randomized to the Stepped Care Intervention</description>
        </group>
        <group group_id="E3">
          <title>Caregivers in Enhanced Usual Care</title>
          <description>Caregivers who were randomized to Enhanced Usual Care</description>
        </group>
        <group group_id="E4">
          <title>Caregivers in Stepped Care Intervention</title>
          <description>Caregivers who were randomized to the Stepped Care Intervention</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="139"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="147"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="118"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="131"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="139"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="147"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="118"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <description>Head-and-neck/lung cancer or complications related to the diagnoses</description>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="139"/>
                <counts group_id="E2" events="18" subjects_affected="18" subjects_at_risk="147"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="118"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory failure with hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="131"/>
              </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="139"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="131"/>
              </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>Evelinn Borrayo, Associate Director</name_or_title>
      <organization>Latino Research and Policy Center, University of Colorado Denver</organization>
      <phone>303-724-0884</phone>
      <email>Evelinn.Borrayo@cuanschutz.edu</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/NCT03016403
org study id: 16-2621.cc
secondary id: AD-1511-33395
nct id: NCT03016403
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Medically under-served (i.e., low-income, uninsured, underinsured) cancer patients generally
      encounter significant disparities in accessing care for their mental health needs while
      undergoing toxic treatments that provide considerable physical and emotional stress. Thus,
      the investigators propose to adapt evidence-based strategies to a stepped-care intervention
      model to address the mental health needs of under-served lung cancer (LC) and head and neck
      cancer (HNC) patients and their caregivers across several levels of symptom severity (e.g.,
      mild, moderate, or severe symptoms of depression and anxiety).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Symptoms of Depression-Patients
time frame: 6-months
description: Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer (CA) Form v1.0 - Depression (30 items). The range is from 8 to 40. Higher score indicates worse outcome (higher depression). Raw scores were used in analyses.
measure: Symptoms of Anxiety-Patients
time frame: 6-months
description: Patient-Reported Outcomes Measurement Information System, Anxiety (PROMIS-Ca) Form v1.0- Anxiety (22 items). The range of scores is between 8 and 40. The raw scores were used. Higher score corresponds to worse outcome.
measure: Change in Coping-Patients
time frame: 6-months
description: Coping Self-Efficacy (26 items). Scores can rage from 0 to 260. Higher score corresponds to better outcome.
measure: Change in Coping-Caregivers
time frame: 6-months
description: Coping Self-Efficacy (26 items). Higher score corresponds to better outcome. Scores can rage from 0 to 260.
The number of caregivers randomized and analyzed was 118 and 131 in the enhanced usual care and intervention groups, respectively.
measure: Symptoms of Anxiety-Caregivers
time frame: 6-months
description: PROMIS Form v1.0 - Anxiety (29 items). The range of scores is from 8 to 40. Higher score indicates worse outcome (higher anxiety). Raw scores were used in analyses.
The number of caregivers randomized and analyzed was 118 and 131 in the enhanced usual care and intervention groups, respectively.
measure: Symptoms of Depression-Caregivers
time frame: 6-months
description: PROMIS Form v1.0 - Depression (28 items). The range is from 8 to 40. Higher score indicates worse outcome (higher depression). Raw scores were used in analyses.
The number of caregivers randomized and analyzed was 118 and 131 in the enhanced usual care and intervention groups, respectively.
measure: Health-Related Quality of Life-Patients
time frame: 6-months
description: FACT-G version 4 (27 items). The range is 0-108. Higher values indicate better QOL.
measure: Perceived Stress-Patients
time frame: 6-months
description: Perceived Stress Scale (PSS) (14 items). The range of scores is 0-40. Higher values indicate higher stress.
measure: Perceived Stress-Caregivers
time frame: 6-months
description: Perceived Stress Scale (PSS) (14 items). The range is from 0 to 40. Higher values indicate higher stress.
measure: Caregiving Burden-Caregivers
time frame: 6-months
description: Zarit Burden Interview (ZBI) (12 items). The range of scores is 0-48. Higher scores represent higher burden.
arm group label: Stepped-Care Intervention
arm group type: Experimental
description: Intervention strategies are grounded in evidence-based Cognitive Behavioral Therapy (CBT), that includes stress management and relaxation treatment strategies and coping skills training. Treatment strategies have been adapted from the Transactional Model of Stress and Coping (TMSC), a theoretical model that predicts that individuals who are able to cope and adapt to the stress related to cancer treatment or caregiving will report less psychological distress than those unable to cope.
arm group label: Enhanced Usual Care
arm group type: Active Comparator
description: Denver Health, St. Mary's and St. Joseph's hospitals provide supportive mental health care for patients such as printed materials, support groups, crisis counseling, and specialized care (e.g., psychiatric medication). Because the amount of usual mental health care that each patient receives varies at each site, the investigators will standardize and monitor the usual care arm across the three sites with an enhanced usual care condition.
intervention type: Behavioral
intervention name: Stepped-Care Intervention
description: The intervention delivered evidence-based CBT and stress management across eight counseling sessions.
arm group label: Stepped-Care Intervention
intervention type: Behavioral
intervention name: Enhanced Usual Care
description: Consists of a list of standard mental health resources offered at the participating hospital, local community, or national non-profit organizations.
arm group label: Enhanced Usual Care
other name: Standard of Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Evelinn A Borrayo, PhD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Head and Neck Neoplasms
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 