xml: <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/NCT06002828</url>
    </required_header>
    <id_info>
      <org_study_id>EAQ211</org_study_id>
      <secondary_id>NCI-2022-05526</secondary_id>
      <secondary_id>EAQ211</secondary_id>
      <secondary_id>ECOG-ACRIN-EAQ211</secondary_id>
      <secondary_id>ECOG-ACRIN-EAQ211</secondary_id>
      <secondary_id>UG1CA189828</secondary_id>
      <nct_id>NCT06002828</nct_id>
    </id_info>
    <brief_title>Evaluating the Impact of Social and Genetic Factors on Outcomes in Adolescent and Young Adult Cancer Survivors</brief_title>
    <official_title>Social Genomic Mechanisms of Health Disparities Among Adolescent and Young Adult (AYA) Survivors of Hodgkin and Non-Hodgkin Lymphoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>ECOG-ACRIN Cancer Research Group</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Cancer Institute (NCI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Eastern Cooperative Oncology Group</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study examines the impact of social and genetic factors on outcomes in adolescent and&#xD;
        young adult (AYA) cancer survivors of Hodgkin or non-Hodgkin lymphoma. Compared to both older&#xD;
        adult and childhood cancer patients, AYAs with cancer experience different diagnoses and&#xD;
        specific biological, clinical, psychological and social factors that affect their risks for&#xD;
        post-treatment morbidity and premature death. Collecting samples of blood samples and health&#xD;
        and treatment information from cancer survivors of Hodgkin or non-Hodgkin lymphoma may help&#xD;
        doctors identify conditions that increase the likelihood of AYAs getting sick and dying after&#xD;
        treatment of cancer and better understand how to address the needs of adolescent and young&#xD;
        adult cancer survivors.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        PRIMARY OBJECTIVE:&#xD;
  &#xD;
        I. To establish the association of social-environmental risk factors on both disease-free&#xD;
        survival (DFS) and overall survival (OS) for adolescent and young adult cancer survivors.&#xD;
  &#xD;
        SECONDARY OBJECTIVES:&#xD;
  &#xD;
        I. To establish the associations of individual resilience factors on DFS and OS for&#xD;
        adolescent and young adult cancer survivors.&#xD;
  &#xD;
        II. To establish the associations of social-environmental risk factors and individual&#xD;
        resilience factors on quality of life (QOL) for adolescent and young adult cancer survivors.&#xD;
  &#xD;
        III. To quantify the extent to which alterations in human gene expression could potentially&#xD;
        mediate the effects of social-environmental risk factors and individual resilience factors on&#xD;
        DFS, and OS for adolescent and young adult cancer survivors.&#xD;
  &#xD;
        EXPLORATORY OBJECTIVE:&#xD;
  &#xD;
        I. To determine whether the relationship between social-environmental risk factors or&#xD;
        individual resilience factors and distal outcomes may be moderated by race/ethnicity, sex and&#xD;
        gender identity, and geography for adolescent and young adult cancer survivors.&#xD;
  &#xD;
        OUTLINE: This is an observational study.&#xD;
  &#xD;
        Participants complete questionnaires about health-related quality of life and undergo&#xD;
        collection of blood samples at baseline and 6, 12, 18, and 24 months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 23, 2024</start_date>
    <completion_date type="Anticipated">April 9, 2028</completion_date>
    <primary_completion_date type="Anticipated">April 9, 2028</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Disease free survival (DFS)</measure>
      <time_frame>Time interval after primary treatment for a cancer ends that the patient survives without any signs or symptoms of thatcancer, assessed up to 2 years</time_frame>
      <description>A gated hypothesis testing procedure will be used to ensure control of the family-wise error rate at 0.05 (two-sided). Cox regression will be used to assess the association of the social-environmental risk factors with the hazard of DFS.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>From participant registration to the date of death or censored at the date of data collection, assessed up to 2 years</time_frame>
      <description>A gated hypothesis testing procedure will be used to ensure control of the familywise error rate at 0.05 (two- sided). OS will be tested only if statistical significance is achieved for DFS. Cox regression will be used to assess the association of the social-environmental risk factors with the hazard of OS.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Comorbidities (including symptoms, late effects)</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Will be assessed using Charlson Comorbidity Index (Patient version) National Cancer Institute Common Toxicity Criteria for Adverse Events.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Quality of life collected via PROMIS-29 v2</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Will use linear mixed models to model the quality of life measure with individual resilience. Individual Resilience Factors will be assessed as follows: Social support will be evaluated using the Duke-UNC Functional Social Support Questionnaire (DUFSS), the sense of purpose and meaning, will be assessed by the Mental Health Continuum Short Form, Behavioral Self-efficacy will be assessed using the PROMIS Short Forms (SF) for managing symptoms, daily activities, social interactions, emotions, and medications and treatment. Indicators of socioeconomic status, assets, and employment/school status will be collected via survey. Other specific demographic indicators to be examined include sexual orientation and gender identity. These metrics will be tested as possible modifiers (&quot;moderators&quot;) of the effects of social-environmental risk factors and resilience factors on gene expression and morbidity, mortality, and HRQOL endpoints.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">2000</enrollment>
    <condition>Hodgkin Lymphoma</condition>
    <condition>Non-Hodgkin Lymphoma</condition>
    <arm_group>
      <arm_group_label>Observational (questionnaires, biospecimen collection)</arm_group_label>
      <description>Participants complete questionnaires about health-related quality of life and undergo collection of blood samples at baseline and 6, 12, 18, and 24 months.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Biospecimen Collection</intervention_name>
      <description>Undergo collection of blood samples</description>
      <arm_group_label>Observational (questionnaires, biospecimen collection)</arm_group_label>
      <other_name>Biological Sample Collection</other_name>
      <other_name>Biospecimen Collected</other_name>
      <other_name>Specimen Collection</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Quality-of-Life Assessment</intervention_name>
      <description>Complete questionnaires</description>
      <arm_group_label>Observational (questionnaires, biospecimen collection)</arm_group_label>
      <other_name>Quality of Life Assessment</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaire Administration</intervention_name>
      <description>Complete questionnaires</description>
      <arm_group_label>Observational (questionnaires, biospecimen collection)</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with treated Hodgkin lymphoma or Non-Hodgkin lymphoma across the United States&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient must be &gt;= 18 years of age at the time of registration&#xD;
  &#xD;
            -  Patient must have been between the ages of 15-39 at the time of their first primary&#xD;
               cancer diagnosis of Hodgkin lymphoma or non-Hodgkin lymphoma (NHL)&#xD;
  &#xD;
            -  Patient must have completed therapy (with a complete response, per clinician&#xD;
               determination) at the time of registration&#xD;
  &#xD;
            -  Patients last date of prior systemic therapy for first primary diagnosis for Hodgkin&#xD;
               lymphoma or non-Hodgkin lymphoma must have been within one year prior to registration&#xD;
  &#xD;
                 -  NOTE: Systemic therapy refers to all anti-cancer therapy, including but not&#xD;
                    limited to chemotherapy, intravenous (IV) or oral targeted medications, or&#xD;
                    radiation, and administered via a clinical trial or standard approach&#xD;
  &#xD;
            -  Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of&#xD;
               0-3&#xD;
  &#xD;
            -  Patient must be English speaking in order to be able to complete the required QOL&#xD;
               forms on this study&#xD;
  &#xD;
                 -  NOTE: Sites cannot translate the associated QOL forms&#xD;
  &#xD;
            -  Patient must not be receiving active therapy for Hodgkin lymphoma or non-Hodgkin&#xD;
               lymphoma&#xD;
  &#xD;
            -  Patient must have internet access through computer, tablet, or smartphone&#xD;
  &#xD;
            -  Patient must have email address&#xD;
  &#xD;
            -  Patient must have the ability to understand and the willingness to sign a written&#xD;
               informed consent document. Patients with impaired decision-making capacity (IDMC) who&#xD;
               have a legally authorized representative (LAR) or caregiver and/or family member&#xD;
               available will also be considered eligible&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Bradley J Zebrack</last_name>
      <role>Principal Investigator</role>
      <affiliation>ECOG-ACRIN Cancer Research Group</affiliation>
    </overall_official>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lymphoma</mesh_term>
      <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06002828
  org study id: EAQ211
  secondary id: NCI-2022-05526
  secondary id: EAQ211
  secondary id: ECOG-ACRIN-EAQ211
  secondary id: ECOG-ACRIN-EAQ211
  secondary id: UG1CA189828
  nct id: NCT06002828
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  This study examines the impact of social and genetic factors on outcomes in adolescent and
        young adult (AYA) cancer survivors of Hodgkin or non-Hodgkin lymphoma. Compared to both older
        adult and childhood cancer patients, AYAs with cancer experience different diagnoses and
        specific biological, clinical, psychological and social factors that affect their risks for
        post-treatment morbidity and premature death. Collecting samples of blood samples and health
        and treatment information from cancer survivors of Hodgkin or non-Hodgkin lymphoma may help
        doctors identify conditions that increase the likelihood of AYAs getting sick and dying after
        treatment of cancer and better understand how to address the needs of adolescent and young
        adult cancer survivors.
  PRIMARY OBJECTIVE:
  
        I. To establish the association of social-environmental risk factors on both disease-free
        survival (DFS) and overall survival (OS) for adolescent and young adult cancer survivors.
  
        SECONDARY OBJECTIVES:
  
        I. To establish the associations of individual resilience factors on DFS and OS for
        adolescent and young adult cancer survivors.
  
        II. To establish the associations of social-environmental risk factors and individual
        resilience factors on quality of life (QOL) for adolescent and young adult cancer survivors.
  
        III. To quantify the extent to which alterations in human gene expression could potentially
        mediate the effects of social-environmental risk factors and individual resilience factors on
        DFS, and OS for adolescent and young adult cancer survivors.
  
        EXPLORATORY OBJECTIVE:
  
        I. To determine whether the relationship between social-environmental risk factors or
        individual resilience factors and distal outcomes may be moderated by race/ethnicity, sex and
        gender identity, and geography for adolescent and young adult cancer survivors.
  
        OUTLINE: This is an observational study.
  
        Participants complete questionnaires about health-related quality of life and undergo
        collection of blood samples at baseline and 6, 12, 18, and 24 months.
  observational model: Cohort
  time perspective: Prospective
  measure: Disease free survival (DFS)
  time frame: Time interval after primary treatment for a cancer ends that the patient survives without any signs or symptoms of thatcancer, assessed up to 2 years
  description: A gated hypothesis testing procedure will be used to ensure control of the family-wise error rate at 0.05 (two-sided). Cox regression will be used to assess the association of the social-environmental risk factors with the hazard of DFS.
  measure: Overall survival (OS)
  time frame: From participant registration to the date of death or censored at the date of data collection, assessed up to 2 years
  description: A gated hypothesis testing procedure will be used to ensure control of the familywise error rate at 0.05 (two- sided). OS will be tested only if statistical significance is achieved for DFS. Cox regression will be used to assess the association of the social-environmental risk factors with the hazard of OS.
  measure: Comorbidities (including symptoms, late effects)
  time frame: Up to 2 years
  description: Will be assessed using Charlson Comorbidity Index (Patient version) National Cancer Institute Common Toxicity Criteria for Adverse Events.
  measure: Quality of life collected via PROMIS-29 v2
  time frame: Up to 2 years
  description: Will use linear mixed models to model the quality of life measure with individual resilience. Individual Resilience Factors will be assessed as follows: Social support will be evaluated using the Duke-UNC Functional Social Support Questionnaire (DUFSS), the sense of purpose and meaning, will be assessed by the Mental Health Continuum Short Form, Behavioral Self-efficacy will be assessed using the PROMIS Short Forms (SF) for managing symptoms, daily activities, social interactions, emotions, and medications and treatment. Indicators of socioeconomic status, assets, and employment/school status will be collected via survey. Other specific demographic indicators to be examined include sexual orientation and gender identity. These metrics will be tested as possible modifiers ("moderators") of the effects of social-environmental risk factors and resilience factors on gene expression and morbidity, mortality, and HRQOL endpoints.
  arm group label: Observational (questionnaires, biospecimen collection)
  description: Participants complete questionnaires about health-related quality of life and undergo collection of blood samples at baseline and 6, 12, 18, and 24 months.
  intervention type: Procedure
  intervention name: Biospecimen Collection
  description: Undergo collection of blood samples
  arm group label: Observational (questionnaires, biospecimen collection)
  other name: Biological Sample Collection
  other name: Biospecimen Collected
  other name: Specimen Collection
  intervention type: Other
  intervention name: Quality-of-Life Assessment
  description: Complete questionnaires
  arm group label: Observational (questionnaires, biospecimen collection)
  other name: Quality of Life Assessment
  intervention type: Other
  intervention name: Questionnaire Administration
  description: Complete questionnaires
  arm group label: Observational (questionnaires, biospecimen collection)
  Blood
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Bradley J Zebrack
  role: Principal Investigator
  affiliation: ECOG-ACRIN Cancer Research Group
  responsible party type: Sponsor
  mesh term: Lymphoma
  mesh term: Lymphoma, Non-Hodgkin