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Trial record 1 of 1 for:    06002828
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Evaluating the Impact of Social and Genetic Factors on Outcomes in Adolescent and Young Adult Cancer Survivors

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ClinicalTrials.gov Identifier: NCT06002828
Recruitment Status : Recruiting
First Posted : August 21, 2023
Last Update Posted : April 5, 2024
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Hodgkin Lymphoma Non-Hodgkin Lymphoma Procedure: Biospecimen Collection Other: Quality-of-Life Assessment Other: Questionnaire Administration

Detailed Description:

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Social Genomic Mechanisms of Health Disparities Among Adolescent and Young Adult (AYA) Survivors of Hodgkin and Non-Hodgkin Lymphoma
Actual Study Start Date : October 13, 2023
Estimated Primary Completion Date : April 9, 2028
Estimated Study Completion Date : April 9, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Groups and Cohorts
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Group/Cohort Intervention/treatment
Observational (questionnaires, biospecimen collection)
Participants complete questionnaires about health-related quality of life and undergo collection of blood samples at baseline and 6, 12, 18, and 24 months.
 Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection

Other: Quality-of-Life Assessment
Complete questionnaires
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Complete questionnaires


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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.

  3. Comorbidities (including symptoms, late effects) [ Time Frame: Up to 2 years ]
    Will be assessed using Charlson Comorbidity Index (Patient version) National Cancer Institute Common Toxicity Criteria for Adverse Events.


Secondary Outcome Measures :
  1. Quality of life collected via PROMIS-29 v2 [ Time Frame: Up to 2 years ]
    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.


Biospecimen Retention:   Samples With DNA
Blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with treated Hodgkin lymphoma or Non-Hodgkin lymphoma across the United States
Criteria

Inclusion Criteria:

  • Patient must be >= 18 years of age at the time of registration
  • Patient must have been between the ages of 15-39 at the time of their first primary cancer diagnosis of Hodgkin lymphoma or non-Hodgkin lymphoma (NHL)
  • Patient must have completed therapy (with a complete response, per clinician determination) at the time of registration

  • Patients last date of prior systemic therapy for first primary diagnosis for Hodgkin lymphoma or non-Hodgkin lymphoma must have been within one year prior to registration

    • NOTE: Systemic therapy refers to all anti-cancer therapy, including but not limited to chemotherapy, intravenous (IV) or oral targeted medications, or radiation, and administered via a clinical trial or standard approach
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-3

  • Patient must be English speaking in order to be able to complete the required QOL forms on this study

    • NOTE: Sites cannot translate the associated QOL forms
  • Patient must not be receiving active therapy for Hodgkin lymphoma or non-Hodgkin lymphoma
  • Patient must have internet access through computer, tablet, or smartphone
  • Patient must have email address
  • Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06002828


Locations
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Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Bradley J Zebrack ECOG-ACRIN Cancer Research Group
More Information
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Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT06002828    
Other Study ID Numbers: EAQ211
NCI-2022-05526 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
EAQ211 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
ECOG-ACRIN-EAQ211 ( Other Identifier: DCP )
ECOG-ACRIN-EAQ211 ( Other Identifier: CTEP )
UG1CA189828 ( U.S. NIH Grant/Contract )
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: April 5, 2024
Last Verified: February 2024
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases