<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/NCT02222337</url>
  </required_header>
  <id_info>
    <org_study_id>AD-13-5635</org_study_id>
    <nct_id>NCT02222337</nct_id>
  </id_info>
  <brief_title>Nueva Vida Intervention for Latina Breast Cancer Survivors and Caregivers</brief_title>
  <official_title>Nueva Vida Intervention: Improving QOL in Latina Breast Cancer Survivors and Their Caregivers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Georgetown University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nueva Vida, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Latinas Contra Cancer</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gilda's Club NYC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>SHARE</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Georgetown University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Latina breast cancer survivors report lower quality of life (QOL) than non-Latina survivors.&#xD;
      Lower QOL can lead to poorer functional and cancer-related survival outcomes. The friends and&#xD;
      family of Latina cancer patients are also impacted by a loved one's diagnosis of breast&#xD;
      cancer. Through strong community-academic partnerships, the investigators seek to improve the&#xD;
      QOL of Latina survivors and their caregivers with a culturally-relevant intervention. In this&#xD;
      project, the investigators plan to further develop and refine the intervention and then test&#xD;
      it through a randomized controlled trial. First, the investigators will conduct in-depth&#xD;
      qualitative interviews with 10 survivor-caregiver dyads (pairs) to see if the intervention&#xD;
      fits for survivors and caregivers in different parts of the country. Then, the investigators&#xD;
      will revise the intervention. Finally, the investigators will test the intervention in a&#xD;
      randomized controlled trial. The investigators will invite 125 survivor-caregiver dyads to be&#xD;
      a part of our study. Half will be asked to complete the intervention and half will be offered&#xD;
      the usual services, such as support groups. The information learned from this study could&#xD;
      help improve the quality of life in Latina breast cancer survivors and their caregivers.&#xD;
      Physicians, survivors, and community groups can also benefit from this study because they&#xD;
      will have more information about the needs of Latina breast cancer survivors. The&#xD;
      investigators hope to use the information to help other types of survivors and caregivers in&#xD;
      the future.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      What is the Nueva Vida Intervention? The &quot;Nueva Vida Intervention: Improving Quality of Life&#xD;
      in Latina Breast Cancer Survivors and Their Caregivers&quot; is a randomized controlled trial&#xD;
      (RCT) that was co-developed by a Latina breast cancer survivor who is trained as a mental&#xD;
      health professional. The program was developed for Nueva Vida, a community-based organization&#xD;
      (CBO) in the Washington, DC metropolitan area that serves Latina breast cancer survivors and&#xD;
      their families. We are comparing the intervention to the usual services provided at our four&#xD;
      partner community-based organizations.&#xD;
&#xD;
      How is the Nueva Vida Intervention Structured? The 8-session psycho-educational quality of&#xD;
      life intervention includes group-based skill-building workshops in which Latina survivors and&#xD;
      their caregivers are part of concurrently-held but separate groups (survivors in one room;&#xD;
      caregivers in another). This separation meets the needs of Latino participants by encouraging&#xD;
      them to freely share their experiences and feelings without worrying about upsetting the&#xD;
      other person. Five of the eight sessions address core topics: Introduction and The Impact of&#xD;
      Cancer on the Family, Stress Management, Improving Communication: Family, Friends, and&#xD;
      Providers, Spirituality and Cancer, and Balancing Physical and Emotional Needs.&#xD;
&#xD;
      The remaining three sessions are selected by the intervention participants based on their own&#xD;
      needs and interests from the following options: Anger Management, Intimacy after Cancer:&#xD;
      Emotional and Sexual, Trauma and Cancer, Role Changes, Understanding Distress and Depression,&#xD;
      Myths and Cancer, Including Others in Helping Caregivers, and Putting Our Lives in Order. At&#xD;
      the end of the intervention everyone participates in a graduation ceremony.&#xD;
&#xD;
      How does the Nueva Vida Intervention Reflect Latino Values? The Nueva Vida intervention&#xD;
      reflects Latino values, including personalismo (warm, personal relationships), familismo&#xD;
      (emphasizing the family unit in managing a cancer diagnosis) and framing the sessions as&#xD;
      workshops to avoid stigma associated with mental health care.&#xD;
&#xD;
      Where will the Nueva Vida Intervention Study take place? We will evaluate the Nueva Vida&#xD;
      Intervention within a multi-site RCT at four community-based organizations in Washington, DC&#xD;
      (Nueva Vida), New York, New York (SHARE, Gilda's Club New York City), and San Jose,&#xD;
      California (Latinas Contra Cancer).&#xD;
&#xD;
      What is Involved in Study Participation? Latina survivors and their caregivers will be&#xD;
      assigned by chance (randomized) to either the Nueva Vida Intervention or to usual care.&#xD;
      Survivors and caregivers assigned to usual care can take part in any and all of the services&#xD;
      provided at one of the four community-based organizations who are study partners. Both&#xD;
      survivors and caregivers will complete informed consent forms and telephone surveys at the&#xD;
      beginning of the study, about 4 months later, and again 6 months later. Survivors and&#xD;
      caregivers receive gift cards in appreciation of their time for completing the surveys.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">January 24, 2017</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>PROMIS Physical Functioning</measure>
    <time_frame>6 months</time_frame>
    <description>Measure Quality of Life physical functioning; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 6-28; A higher score = higher physical functioning</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PROMIS Satisfaction With Social Roles</measure>
    <time_frame>6 months</time_frame>
    <description>Measure Quality of Life satisfaction with social roles domain; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10; Range of the raw score = 6-30; A higher score = higher satisfaction with social roles</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PROMIS Anxiety</measure>
    <time_frame>6 months</time_frame>
    <description>Quality of life: Anxiety; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 6 to 30. A higher score = higher anxiety</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PROMIS Depression</measure>
    <time_frame>6 months</time_frame>
    <description>Quality of life: depression; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 6-30; A higher score = higher depression</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PROMIS Fatigue</measure>
    <time_frame>6 months</time_frame>
    <description>Quality of life: fatigue; 4 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 4-20; A higher score = higher fatigue</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Communication - Survivors Only - Patient Satisfaction With Care (PSQ-18 Communication Subscale)</measure>
    <time_frame>6-months</time_frame>
    <description>Communication with providers in terms of overall satisfaction with communication. Range for subscale is 1-5; higher scores indicate higher communication satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy - Survivors Only - Cancer Behavior Inventory (CBI)</measure>
    <time_frame>6 Months</time_frame>
    <description>Self-efficacy; cancer survivors' confidence in coping with cancer and its treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction With Care - Survivors Only - Experience of Care and Health Outcomes (ECHOS-NHL)</measure>
    <time_frame>6-months</time_frame>
    <description>Satisfaction with health care received by the breast cancer survivor from her oncology health care providers or general health care providers</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">272</enrollment>
  <condition>Quality of Life</condition>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Nueva Vida Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nueva Vida Intervention consists of 8 sessions of a skills-building group held twice a month for 4 months. Latina survivors and their caregivers arrive at the group together, separate into different rooms to learn the coping and communication skills, and then join together for discussion of the topic.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nueva Vida Intervention</intervention_name>
    <description>The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic. This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond. The specific topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication.</description>
    <arm_group_label>Nueva Vida Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Survivors: Latina, has been diagnosed with breast cancer, speaks English or Spanish,&#xD;
             has a Caregiver who is willing to participate.&#xD;
&#xD;
          -  Caregivers: a primary caregiver for a Latina breast cancer survivor, speak English or&#xD;
             Spanish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to understand spoken English and/or Spanish and/or&#xD;
&#xD;
          2. Cognitive impairment that precludes informed consent (determined by the PIs or&#xD;
             Co-Investigators who are mental health professionals).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristi D Graves, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Georgetown University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Latinas Contra Cancer</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nueva Vida</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gilda's Club New York City</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SHARE</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>95110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.pcori.org/research-in-action/improving-quality-life-latinas-breast-cancer</url>
    <description>Description of the project on the Patient Centered Outcomes Research Institute (PCORI) website</description>
  </link>
  <reference>
    <citation>Rush CL, Darling M, Elliott MG, Febus-Sampayo I, Kuo C, Munoz J, Duron Y, Torres M, Galvan CC, Gonzalez F, Caicedo L, Napoles A, Jensen RE, Anderson E, Graves KD. Engaging Latina cancer survivors, their caregivers, and community partners in a randomized controlled trial: Nueva Vida intervention. Qual Life Res. 2015 May;24(5):1107-18. doi: 10.1007/s11136-014-0847-9. Epub 2014 Nov 8.</citation>
    <PMID>25377349</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <results_first_submitted>July 7, 2017</results_first_submitted>
  <results_first_submitted_qc>February 20, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 3, 2019</results_first_posted>
  <last_update_submitted>February 20, 2019</last_update_submitted>
  <last_update_submitted_qc>February 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Georgetown University</investigator_affiliation>
    <investigator_full_name>Kristi Graves, PhD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>behavioral intervention</keyword>
  <keyword>quality of life</keyword>
  <keyword>breast cancer</keyword>
  <keyword>Latina</keyword>
  <keyword>caregiver</keyword>
  <keyword>PCORI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <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>July 8, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT02222337/ICF_000.pdf</document_url>
    </provided_document>
    <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>December 17, 2012</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT02222337/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>We reconciled the prior enrollment number in the Protocol Section (i.e., &quot;272&quot;) that had conflicted with the number of participants started in the Participant Flow module (i.e., &quot;270&quot;). The discrepancy was because two participants enrolled but withdrew prior to the baseline interview. We thus did not have any data on these 2 participants.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Nueva Vida Intervention</title>
          <description>Nueva Vida Intervention consists of 8 sessions of a skills-building group held twice a month for 4 months. Latina survivors and their caregivers arrive at the group together, separate into different rooms to learn the coping and communication skills, and then join together for discussion of the topic.&#xD;
Nueva Vida Intervention: The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic. This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond. The topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication.</description>
        </group>
        <group group_id="P2">
          <title>Usual Care</title>
          <description>Usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="140"/>
                <participants group_id="P2" count="132">132 participants were enrolled but 2 withdrew and never provided any data.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="114"/>
                <participants group_id="P2" count="108"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Two participants enrolled in the study but withdrew prior to the baseline interview (thus, N = 130). Baseline analysis was conducted by 1) randomization, and 2) participant type. Data was missing for certain measures; numbers analyzed are adjusted accordingly.</population>
      <group_list>
        <group group_id="B1">
          <title>Nueva Vida Intervention</title>
          <description>Nueva Vida Intervention consists of 8 sessions of a skills-building group held twice a month for 4 months. Latina survivors and their caregivers arrive at the group together, separate into different rooms to learn the coping and communication skills, and then join together for discussion of the topic.&#xD;
Nueva Vida Intervention: The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic. This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond. The topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication.</description>
        </group>
        <group group_id="B2">
          <title>Usual Care</title>
          <description>Usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="140"/>
            <count group_id="B2" value="130"/>
            <count group_id="B3" value="270"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Baseline analysis was conducted by 1) randomization, and 2) participant type. Thus, although there were 140 intervention participants and 130 usual care participants, these groups were separated further to be analyzed by survivor and caregiver status. Further, data was missing for certain measures; numbers analyzed are adjusted accordingly.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Survivors</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="69"/>
                    <count group_id="B2" value="65"/>
                    <count group_id="B3" value="134"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="115"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caregivers</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="67"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="118"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Baseline analysis was conducted by 1) randomization, and 2) participant type. Thus, although there were 140 intervention participants and 130 usual care participants, these groups were separated further to be analyzed by survivor and caregiver status. Further, data was missing for certain measures; numbers analyzed are adjusted accordingly.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Survivors</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="70"/>
                    <count group_id="B2" value="65"/>
                    <count group_id="B3" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="135"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caregivers</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="70"/>
                    <count group_id="B2" value="65"/>
                    <count group_id="B3" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <population>Baseline analysis was conducted by 1) randomization, and 2) participant type. Thus, although there were 140 intervention participants and 130 usual care participants, these groups were separated further to be analyzed by survivor and caregiver status. Further, data was missing for certain measures; numbers analyzed are adjusted accordingly.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Survivors</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="70"/>
                    <count group_id="B2" value="65"/>
                    <count group_id="B3" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="135"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caregivers</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="70"/>
                    <count group_id="B2" value="65"/>
                    <count group_id="B3" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="133"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <population>Baseline analysis was conducted by 1) randomization, and 2) participant type. Thus, although there were 140 intervention participants and 130 usual care participants, these groups were separated further to be analyzed by survivor and caregiver status. Further, data was missing for certain measures; numbers analyzed are adjusted accordingly.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Survivors</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="70"/>
                    <count group_id="B2" value="64"/>
                    <count group_id="B3" value="134"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caregivers</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="70"/>
                    <count group_id="B2" value="65"/>
                    <count group_id="B3" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Satisfaction with Care Experience of Care and Health Outcomes (ECHOS-NHL)</title>
          <description>This measure was administered to Survivors only. 11 items; Range: 10-44; Higher scores = better communication</description>
          <population>Baseline analysis was conducted by 1) randomization, and 2) participant type. Thus, although there were 140 intervention participants and 130 usual care participants, these groups were separated further to be analyzed by survivor and caregiver status. Further, data was missing for certain measures; numbers analyzed are adjusted accordingly.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="69"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="132"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.68" spread="5.87"/>
                    <measurement group_id="B2" value="34.35" spread="4.88"/>
                    <measurement group_id="B3" value="34" spread="5.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Self-Efficacy - Survivors Only - Cancer Behavior Inventory (CBI)</title>
          <description>12 items. The CBI-B score is calculated as the sum of all 12 items, range = 12-108. A higher score = higher confidence.</description>
          <population>Baseline analysis was conducted by 1) randomization, and 2) participant type. Thus, although there were 140 intervention participants and 130 usual care participants, these groups were separated further to be analyzed by survivor and caregiver status. Further, data was missing for certain measures; numbers analyzed are adjusted accordingly.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="70"/>
                    <count group_id="B2" value="65"/>
                    <count group_id="B3" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="100.07" spread="21.28"/>
                    <measurement group_id="B2" value="101.60" spread="19.11"/>
                    <measurement group_id="B3" value="100.81" spread="20.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Communication - Patient Satisfaction with Care (PSQ-18 Communication Subscale)</title>
          <description>This scale was administered to Survivors only. 6 items; Range: 1-5; Higher scores = higher general satisfaction with care.</description>
          <population>Baseline analysis was conducted by 1) randomization, and 2) participant type. Thus, although there were 140 intervention participants and 130 usual care participants, these groups were separated further to be analyzed by survivor and caregiver status. Further, data was missing for certain measures; numbers analyzed are adjusted accordingly.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="69"/>
                    <count group_id="B2" value="64"/>
                    <count group_id="B3" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.28" spread="0.91"/>
                    <measurement group_id="B2" value="2.28" spread="0.93"/>
                    <measurement group_id="B3" value="2.28" spread="0.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>PROMIS Anxiety</title>
          <description>6 items; Sum and then use IRT to standardize the score. Standardized Mean of 50; SD of 10. Range of the raw score = 6 to 30. Reference value for breast cancer survivors T-score is 49.6. A higher score = higher anxiety.</description>
          <population>Baseline analysis was conducted by 1) randomization, and 2) participant type. Thus, although there were 140 intervention participants and 130 usual care participants, these groups were separated further to be analyzed by survivor and caregiver status. Further, data was missing for certain measures; numbers analyzed are adjusted accordingly.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Survivors</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="70"/>
                    <count group_id="B2" value="65"/>
                    <count group_id="B3" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.3" spread="12.97"/>
                    <measurement group_id="B2" value="52.94" spread="9.95"/>
                    <measurement group_id="B3" value="53.65" spread="11.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caregivers</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="70"/>
                    <count group_id="B2" value="65"/>
                    <count group_id="B3" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.9" spread="9.76"/>
                    <measurement group_id="B2" value="50.35" spread="9.26"/>
                    <measurement group_id="B3" value="51.15" spread="9.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>PROMIS Depression</title>
          <description>6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 6-30; Reference value for breast cancer survivors T-Score in Depression is 48.5. A higher score = higher depression</description>
          <population>Baseline analysis was conducted by 1) randomization, and 2) participant type. Thus, although there were 140 intervention participants and 130 usual care participants, these groups were separated further to be analyzed by survivor and caregiver status. Further, data was missing for certain measures; numbers analyzed are adjusted accordingly.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Survivors</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="70"/>
                    <count group_id="B2" value="65"/>
                    <count group_id="B3" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.35" spread="12.11"/>
                    <measurement group_id="B2" value="48.22" spread="9.52"/>
                    <measurement group_id="B3" value="49.84" spread="11.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caregivers</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="70"/>
                    <count group_id="B2" value="65"/>
                    <count group_id="B3" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46.72" spread="9.32"/>
                    <measurement group_id="B2" value="45.10" spread="8.24"/>
                    <measurement group_id="B3" value="45.94" spread="8.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>PROMIS Fatigue</title>
          <description>4 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 4-20; Reference value for breast cancer survivors T-Score for Fatigue is 52.5. A higher score = higher fatigue</description>
          <population>Baseline analysis was conducted by 1) randomization, and 2) participant type. Thus, although there were 140 intervention participants and 130 usual care participants, these groups were separated further to be analyzed by survivor and caregiver status. Further, data was missing for certain measures; numbers analyzed are adjusted accordingly.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Survivors</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="68"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="131"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52.95" spread="13.03"/>
                    <measurement group_id="B2" value="49.57" spread="11.99"/>
                    <measurement group_id="B3" value="51.33" spread="12.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caregivers</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="69"/>
                    <count group_id="B2" value="65"/>
                    <count group_id="B3" value="134"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45.12" spread="11.24"/>
                    <measurement group_id="B2" value="44.14" spread="9.95"/>
                    <measurement group_id="B3" value="44.64" spread="10.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>PROMIS Physical Functioning</title>
          <description>6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 6-28; Reference value for breast cancer survivors T-Score for Physical Functioning is 44.9. A higher score = higher physical functioning</description>
          <population>Baseline analysis was conducted by 1) randomization, and 2) participant type. Thus, although there were 140 intervention participants and 130 usual care participants, these groups were separated further to be analyzed by survivor and caregiver status. Further, data was missing for certain measures; numbers analyzed are adjusted accordingly.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Survivors</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="70"/>
                    <count group_id="B2" value="65"/>
                    <count group_id="B3" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.14" spread="9.15"/>
                    <measurement group_id="B2" value="44.33" spread="9.64"/>
                    <measurement group_id="B3" value="44.23" spread="9.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caregivers</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="70"/>
                    <count group_id="B2" value="65"/>
                    <count group_id="B3" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.71" spread="7.54"/>
                    <measurement group_id="B2" value="53.72" spread="7.14"/>
                    <measurement group_id="B3" value="53.72" spread="7.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>PROMIS Satisfaction With Social Roles</title>
          <description>6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10; Range of the raw score = 6-30; Reference value for breast cancer survivors T-Score for Satisfaction with Social Roles is 50.7. A higher score = higher satisfaction with social roles</description>
          <population>Baseline analysis was conducted by 1) randomization, and 2) participant type. Thus, although there were 140 intervention participants and 130 usual care participants, these groups were separated further to be analyzed by survivor and caregiver status. Further, data was missing for certain measures; numbers analyzed are adjusted accordingly.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Survivors</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="69"/>
                    <count group_id="B2" value="63"/>
                    <count group_id="B3" value="132"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47.79" spread="7.67"/>
                    <measurement group_id="B2" value="48.99" spread="7.71"/>
                    <measurement group_id="B3" value="48.37" spread="7.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caregivers</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="70"/>
                    <count group_id="B2" value="65"/>
                    <count group_id="B3" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.18" spread="8.09"/>
                    <measurement group_id="B2" value="55.36" spread="7.88"/>
                    <measurement group_id="B3" value="55.27" spread="7.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>PROMIS Physical Functioning</title>
        <description>Measure Quality of Life physical functioning; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 6-28; A higher score = higher physical functioning</description>
        <time_frame>6 months</time_frame>
        <population>Cancer survivors</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care Survivors</title>
            <description>Survivors randomized to usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care Caregivers</title>
            <description>Caregivers randomized to usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.</description>
          </group>
          <group group_id="O3">
            <title>Nueva Vida Intervetion Survivors</title>
            <description>Survivors randomized to the Nueva Vida Intervention: 8 sessions of a skills-building group held twice a month for 4 months. Latina survivors and their caregivers arrive at the group together, separate into different rooms to learn the coping and communication skills, and then join together for discussion of the topic.&#xD;
The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic. This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond. The topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication.</description>
          </group>
          <group group_id="O4">
            <title>Nueva Vida Intervention Caregivers</title>
            <description>Caregivers randomized to the Nueva Vida Intervention: 8 sessions of a skills-building group held twice a month for 4 months. Latina survivors and their caregivers arrive at the group together, separate into different rooms to learn the coping and communication skills, and then join together for discussion of the topic.&#xD;
The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic. This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond. The topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication.</description>
          </group>
        </group_list>
        <measure>
          <title>PROMIS Physical Functioning</title>
          <description>Measure Quality of Life physical functioning; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 6-28; A higher score = higher physical functioning</description>
          <population>Cancer survivors</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="51"/>
                <count group_id="O3" value="57"/>
                <count group_id="O4" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.61" spread="8.71"/>
                    <measurement group_id="O2" value="53.82" spread="7.34"/>
                    <measurement group_id="O3" value="45.07" spread="9.20"/>
                    <measurement group_id="O4" value="52.99" spread="7.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>PROMIS Satisfaction With Social Roles</title>
        <description>Measure Quality of Life satisfaction with social roles domain; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10; Range of the raw score = 6-30; A higher score = higher satisfaction with social roles</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care Survivors</title>
            <description>Survivors randomized to usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care Caregivers</title>
            <description>Caregivers randomized to usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.</description>
          </group>
          <group group_id="O3">
            <title>Nueva Vida Intervetion Survivors</title>
            <description>Survivors randomized to the Nueva Vida Intervention: 8 sessions of a skills-building group held twice a month for 4 months. Latina survivors and their caregivers arrive at the group together, separate into different rooms to learn the coping and communication skills, and then join together for discussion of the topic.&#xD;
The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic. This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond. The topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication.</description>
          </group>
          <group group_id="O4">
            <title>Nueva Vida Intervention Caregivers</title>
            <description>Caregivers randomized to the Nueva Vida Intervention: 8 sessions of a skills-building group held twice a month for 4 months. Latina survivors and their caregivers arrive at the group together, separate into different rooms to learn the coping and communication skills, and then join together for discussion of the topic.&#xD;
The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic. This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond. The topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication.</description>
          </group>
        </group_list>
        <measure>
          <title>PROMIS Satisfaction With Social Roles</title>
          <description>Measure Quality of Life satisfaction with social roles domain; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10; Range of the raw score = 6-30; A higher score = higher satisfaction with social roles</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="51"/>
                <count group_id="O3" value="57"/>
                <count group_id="O4" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.84" spread="10.11"/>
                    <measurement group_id="O2" value="58.64" spread="5.93"/>
                    <measurement group_id="O3" value="54.07" spread="9.87"/>
                    <measurement group_id="O4" value="59.45" spread="6.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>PROMIS Anxiety</title>
        <description>Quality of life: Anxiety; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 6 to 30. A higher score = higher anxiety</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care Survivors</title>
            <description>Survivors randomized to usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care Caregivers</title>
            <description>Caregivers randomized to usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.</description>
          </group>
          <group group_id="O3">
            <title>Nueva Vida Intervetion Survivors</title>
            <description>Survivors randomized to the Nueva Vida Intervention: 8 sessions of a skills-building group held twice a month for 4 months. Latina survivors and their caregivers arrive at the group together, separate into different rooms to learn the coping and communication skills, and then join together for discussion of the topic.&#xD;
The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic. This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond. The topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication.</description>
          </group>
          <group group_id="O4">
            <title>Nueva Vida Intervention Caregivers</title>
            <description>Caregivers randomized to the Nueva Vida Intervention: 8 sessions of a skills-building group held twice a month for 4 months. Latina survivors and their caregivers arrive at the group together, separate into different rooms to learn the coping and communication skills, and then join together for discussion of the topic.&#xD;
The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic. This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond. The topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication.</description>
          </group>
        </group_list>
        <measure>
          <title>PROMIS Anxiety</title>
          <description>Quality of life: Anxiety; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 6 to 30. A higher score = higher anxiety</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="51"/>
                <count group_id="O3" value="57"/>
                <count group_id="O4" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.93" spread="12.04"/>
                    <measurement group_id="O2" value="48.41" spread="8.61"/>
                    <measurement group_id="O3" value="50.90" spread="11.99"/>
                    <measurement group_id="O4" value="48.70" spread="8.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>PROMIS Depression</title>
        <description>Quality of life: depression; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 6-30; A higher score = higher depression</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care Survivors</title>
            <description>Survivors randomized to usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care Caregivers</title>
            <description>Caregivers randomized to usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.</description>
          </group>
          <group group_id="O3">
            <title>Nueva Vida Intervetion Survivors</title>
            <description>Survivors randomized to the Nueva Vida Intervention: 8 sessions of a skills-building group held twice a month for 4 months. Latina survivors and their caregivers arrive at the group together, separate into different rooms to learn the coping and communication skills, and then join together for discussion of the topic.&#xD;
The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic. This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond. The topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication.</description>
          </group>
          <group group_id="O4">
            <title>Nueva Vida Intervention Caregivers</title>
            <description>Caregivers randomized to the Nueva Vida Intervention: 8 sessions of a skills-building group held twice a month for 4 months. Latina survivors and their caregivers arrive at the group together, separate into different rooms to learn the coping and communication skills, and then join together for discussion of the topic.&#xD;
The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic. This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond. The topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication.</description>
          </group>
        </group_list>
        <measure>
          <title>PROMIS Depression</title>
          <description>Quality of life: depression; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 6-30; A higher score = higher depression</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="51"/>
                <count group_id="O3" value="57"/>
                <count group_id="O4" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.43" spread="9.46"/>
                    <measurement group_id="O2" value="43.95" spread="7.16"/>
                    <measurement group_id="O3" value="47.35" spread="11.13"/>
                    <measurement group_id="O4" value="44.49" spread="7.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>PROMIS Fatigue</title>
        <description>Quality of life: fatigue; 4 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 4-20; A higher score = higher fatigue</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care Survivors</title>
            <description>Survivors randomized to usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care Caregivers</title>
            <description>Caregivers randomized to usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.</description>
          </group>
          <group group_id="O3">
            <title>Nueva Vida Intervetion Survivors</title>
            <description>Survivors randomized to the Nueva Vida Intervention: 8 sessions of a skills-building group held twice a month for 4 months. Latina survivors and their caregivers arrive at the group together, separate into different rooms to learn the coping and communication skills, and then join together for discussion of the topic.&#xD;
The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic. This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond. The topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication.</description>
          </group>
          <group group_id="O4">
            <title>Nueva Vida Intervention Caregivers</title>
            <description>Caregivers randomized to the Nueva Vida Intervention: 8 sessions of a skills-building group held twice a month for 4 months. Latina survivors and their caregivers arrive at the group together, separate into different rooms to learn the coping and communication skills, and then join together for discussion of the topic.&#xD;
The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic. This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond. The topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication.</description>
          </group>
        </group_list>
        <measure>
          <title>PROMIS Fatigue</title>
          <description>Quality of life: fatigue; 4 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 4-20; A higher score = higher fatigue</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="51"/>
                <count group_id="O3" value="57"/>
                <count group_id="O4" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.07" spread="12.85"/>
                    <measurement group_id="O2" value="53.06" spread="12.38"/>
                    <measurement group_id="O3" value="47.83" spread="10.48"/>
                    <measurement group_id="O4" value="46.68" spread="10.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Communication - Survivors Only - Patient Satisfaction With Care (PSQ-18 Communication Subscale)</title>
        <description>Communication with providers in terms of overall satisfaction with communication. Range for subscale is 1-5; higher scores indicate higher communication satisfaction.</description>
        <time_frame>6-months</time_frame>
        <population>Some participants passed away, withdrew, or were lost to follow up after baseline. Data was missing for certain measures; numbers analyzed are adjusted accordingly. Analysis was conducted by 1) randomization, and 2) participant type.</population>
        <group_list>
          <group group_id="O1">
            <title>Nueva Vida Intervention</title>
            <description>Nueva Vida Intervention consists of 8 sessions of a skills-building group held twice a month for 4 months. Latina survivors and their caregivers arrive at the group together, separate into different rooms to learn the coping and communication skills, and then join together for discussion of the topic.&#xD;
Nueva Vida Intervention: The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic. This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond. The topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Communication - Survivors Only - Patient Satisfaction With Care (PSQ-18 Communication Subscale)</title>
          <description>Communication with providers in terms of overall satisfaction with communication. Range for subscale is 1-5; higher scores indicate higher communication satisfaction.</description>
          <population>Some participants passed away, withdrew, or were lost to follow up after baseline. Data was missing for certain measures; numbers analyzed are adjusted accordingly. Analysis was conducted by 1) randomization, and 2) participant type.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.52" spread="1.94"/>
                    <measurement group_id="O2" value="3.23" spread="1.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Self-Efficacy - Survivors Only - Cancer Behavior Inventory (CBI)</title>
        <description>Self-efficacy; cancer survivors' confidence in coping with cancer and its treatment</description>
        <time_frame>6 Months</time_frame>
        <population>Some participants passed away, withdrew, or were lost to follow up after baseline. Data was missing for certain measures; numbers analyzed are adjusted accordingly. Analysis was conducted by 1) randomization, and 2) participant type.</population>
        <group_list>
          <group group_id="O1">
            <title>Nueva Vida Intervention</title>
            <description>Nueva Vida Intervention consists of 8 sessions of a skills-building group held twice a month for 4 months. Latina survivors and their caregivers arrive at the group together, separate into different rooms to learn the coping and communication skills, and then join together for discussion of the topic.&#xD;
Nueva Vida Intervention: The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic. This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond. The topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-Efficacy - Survivors Only - Cancer Behavior Inventory (CBI)</title>
          <description>Self-efficacy; cancer survivors' confidence in coping with cancer and its treatment</description>
          <population>Some participants passed away, withdrew, or were lost to follow up after baseline. Data was missing for certain measures; numbers analyzed are adjusted accordingly. Analysis was conducted by 1) randomization, and 2) participant type.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106.96" spread="19.59"/>
                    <measurement group_id="O2" value="107.96" spread="17.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satisfaction With Care - Survivors Only - Experience of Care and Health Outcomes (ECHOS-NHL)</title>
        <description>Satisfaction with health care received by the breast cancer survivor from her oncology health care providers or general health care providers</description>
        <time_frame>6-months</time_frame>
        <population>Some participants passed away, withdrew, or were lost to follow up after baseline. Data was missing for certain measures; numbers analyzed are adjusted accordingly. Analysis was conducted by 1) randomization, and 2) participant type.</population>
        <group_list>
          <group group_id="O1">
            <title>Nueva Vida Intervention</title>
            <description>Nueva Vida Intervention consists of 8 sessions of a skills-building group held twice a month for 4 months. Latina survivors and their caregivers arrive at the group together, separate into different rooms to learn the coping and communication skills, and then join together for discussion of the topic.&#xD;
Nueva Vida Intervention: The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic. This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond. The topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction With Care - Survivors Only - Experience of Care and Health Outcomes (ECHOS-NHL)</title>
          <description>Satisfaction with health care received by the breast cancer survivor from her oncology health care providers or general health care providers</description>
          <population>Some participants passed away, withdrew, or were lost to follow up after baseline. Data was missing for certain measures; numbers analyzed are adjusted accordingly. Analysis was conducted by 1) randomization, and 2) participant type.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.04" spread="4.48"/>
                    <measurement group_id="O2" value="34.63" spread="4.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected from time of enrollment through 6-month follow-up (3 years).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Nueva Vida Intervention</title>
          <description>Nueva Vida Intervention consists of 8 sessions of a skills-building group held twice a month for 4 months. Latina survivors and their caregivers arrive at the group together, separate into different rooms to learn the coping and communication skills, and then join together for discussion of the topic.&#xD;
Nueva Vida Intervention: The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic. This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond. The topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication.</description>
        </group>
        <group group_id="E2">
          <title>Usual Care</title>
          <description>Usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="130"/>
              </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="140"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="130"/>
              </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>
    <limitations_and_caveats>Difficulty tracking all approached and eligible participants in terms of number of individuals who declined the study due to recruitment at multiple community events and community sites.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Kristi Graves, PhD</name_or_title>
      <organization>Lombardi Comprehensive Cancer Center, Georgetown University</organization>
      <phone>202-687-1591</phone>
      <email>Kristi.Graves@georgetown.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/NCT02222337
org study id: AD-13-5635
nct id: NCT02222337
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Latina breast cancer survivors report lower quality of life (QOL) than non-Latina survivors.
      Lower QOL can lead to poorer functional and cancer-related survival outcomes. The friends and
      family of Latina cancer patients are also impacted by a loved one's diagnosis of breast
      cancer. Through strong community-academic partnerships, the investigators seek to improve the
      QOL of Latina survivors and their caregivers with a culturally-relevant intervention. In this
      project, the investigators plan to further develop and refine the intervention and then test
      it through a randomized controlled trial. First, the investigators will conduct in-depth
      qualitative interviews with 10 survivor-caregiver dyads (pairs) to see if the intervention
      fits for survivors and caregivers in different parts of the country. Then, the investigators
      will revise the intervention. Finally, the investigators will test the intervention in a
      randomized controlled trial. The investigators will invite 125 survivor-caregiver dyads to be
      a part of our study. Half will be asked to complete the intervention and half will be offered
      the usual services, such as support groups. The information learned from this study could
      help improve the quality of life in Latina breast cancer survivors and their caregivers.
      Physicians, survivors, and community groups can also benefit from this study because they
      will have more information about the needs of Latina breast cancer survivors. The
      investigators hope to use the information to help other types of survivors and caregivers in
      the future.
What is the Nueva Vida Intervention? The "Nueva Vida Intervention: Improving Quality of Life
      in Latina Breast Cancer Survivors and Their Caregivers" is a randomized controlled trial
      (RCT) that was co-developed by a Latina breast cancer survivor who is trained as a mental
      health professional. The program was developed for Nueva Vida, a community-based organization
      (CBO) in the Washington, DC metropolitan area that serves Latina breast cancer survivors and
      their families. We are comparing the intervention to the usual services provided at our four
      partner community-based organizations.

      How is the Nueva Vida Intervention Structured? The 8-session psycho-educational quality of
      life intervention includes group-based skill-building workshops in which Latina survivors and
      their caregivers are part of concurrently-held but separate groups (survivors in one room;
      caregivers in another). This separation meets the needs of Latino participants by encouraging
      them to freely share their experiences and feelings without worrying about upsetting the
      other person. Five of the eight sessions address core topics: Introduction and The Impact of
      Cancer on the Family, Stress Management, Improving Communication: Family, Friends, and
      Providers, Spirituality and Cancer, and Balancing Physical and Emotional Needs.

      The remaining three sessions are selected by the intervention participants based on their own
      needs and interests from the following options: Anger Management, Intimacy after Cancer:
      Emotional and Sexual, Trauma and Cancer, Role Changes, Understanding Distress and Depression,
      Myths and Cancer, Including Others in Helping Caregivers, and Putting Our Lives in Order. At
      the end of the intervention everyone participates in a graduation ceremony.

      How does the Nueva Vida Intervention Reflect Latino Values? The Nueva Vida intervention
      reflects Latino values, including personalismo (warm, personal relationships), familismo
      (emphasizing the family unit in managing a cancer diagnosis) and framing the sessions as
      workshops to avoid stigma associated with mental health care.

      Where will the Nueva Vida Intervention Study take place? We will evaluate the Nueva Vida
      Intervention within a multi-site RCT at four community-based organizations in Washington, DC
      (Nueva Vida), New York, New York (SHARE, Gilda's Club New York City), and San Jose,
      California (Latinas Contra Cancer).

      What is Involved in Study Participation? Latina survivors and their caregivers will be
      assigned by chance (randomized) to either the Nueva Vida Intervention or to usual care.
      Survivors and caregivers assigned to usual care can take part in any and all of the services
      provided at one of the four community-based organizations who are study partners. Both
      survivors and caregivers will complete informed consent forms and telephone surveys at the
      beginning of the study, about 4 months later, and again 6 months later. Survivors and
      caregivers receive gift cards in appreciation of their time for completing the surveys.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: PROMIS Physical Functioning
time frame: 6 months
description: Measure Quality of Life physical functioning; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 6-28; A higher score = higher physical functioning
measure: PROMIS Satisfaction With Social Roles
time frame: 6 months
description: Measure Quality of Life satisfaction with social roles domain; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10; Range of the raw score = 6-30; A higher score = higher satisfaction with social roles
measure: PROMIS Anxiety
time frame: 6 months
description: Quality of life: Anxiety; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 6 to 30. A higher score = higher anxiety
measure: PROMIS Depression
time frame: 6 months
description: Quality of life: depression; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 6-30; A higher score = higher depression
measure: PROMIS Fatigue
time frame: 6 months
description: Quality of life: fatigue; 4 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 4-20; A higher score = higher fatigue
measure: Communication - Survivors Only - Patient Satisfaction With Care (PSQ-18 Communication Subscale)
time frame: 6-months
description: Communication with providers in terms of overall satisfaction with communication. Range for subscale is 1-5; higher scores indicate higher communication satisfaction.
measure: Self-Efficacy - Survivors Only - Cancer Behavior Inventory (CBI)
time frame: 6 Months
description: Self-efficacy; cancer survivors' confidence in coping with cancer and its treatment
measure: Satisfaction With Care - Survivors Only - Experience of Care and Health Outcomes (ECHOS-NHL)
time frame: 6-months
description: Satisfaction with health care received by the breast cancer survivor from her oncology health care providers or general health care providers
arm group label: Nueva Vida Intervention
arm group type: Active Comparator
description: Nueva Vida Intervention consists of 8 sessions of a skills-building group held twice a month for 4 months. Latina survivors and their caregivers arrive at the group together, separate into different rooms to learn the coping and communication skills, and then join together for discussion of the topic.
arm group label: Usual Care
arm group type: No Intervention
description: Usual care as provided by each of our 4 community-based organization partners. Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.
intervention type: Behavioral
intervention name: Nueva Vida Intervention
description: The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic. This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond. The specific topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication.
arm group label: Nueva Vida Intervention
criteria: 
gender: All
minimum age: N/A
maximum age: 85 Years
healthy volunteers: No
last name: Kristi D Graves, Ph.D.
role: Principal Investigator
affiliation: Georgetown University
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.pcori.org/research-in-action/improving-quality-life-latinas-breast-cancer
description: Description of the project on the Patient Centered Outcomes Research Institute (PCORI) website
citation: Rush CL, Darling M, Elliott MG, Febus-Sampayo I, Kuo C, Munoz J, Duron Y, Torres M, Galvan CC, Gonzalez F, Caicedo L, Napoles A, Jensen RE, Anderson E, Graves KD. Engaging Latina cancer survivors, their caregivers, and community partners in a randomized controlled trial: Nueva Vida intervention. Qual Life Res. 2015 May;24(5):1107-18. doi: 10.1007/s11136-014-0847-9. Epub 2014 Nov 8.
PMID: 25377349
responsible party type: Principal Investigator
investigator affiliation: Georgetown University
investigator full name: Kristi Graves, PhD
investigator title: Associate Professor
mesh term: Breast Neoplasms
sharing ipd: Undecided
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Difficulty tracking all approached and eligible participants in terms of number of individuals who declined the study due to recruitment at multiple community events and community sites.
point of contact: 