Evaluating the Impact of Social and Genetic Factors on Outcomes in Adolescent and Young Adult Cancer Survivors

• ClinicalTrials.gov Identifier: NCT06002828
• Recruitment Status: Recruiting
• First Posted: August 21, 2023
• Last Update Posted: May 3, 2024
• Sponsor: ECOG-ACRIN Cancer Research Group
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

Tracking Information

• First Submitted Date: August 14, 2023
• First Posted Date: August 21, 2023
• Last Update Posted Date: May 3, 2024
• Actual Study Start Date: October 13, 2023
• Estimated Primary Completion Date: April 9, 2028 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 18, 2023)

• 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.
• 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.
• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 18, 2023)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluating the Impact of Social and Genetic Factors on Outcomes in Adolescent and Young Adult Cancer Survivors
• Official Title: Social Genomic Mechanisms of Health Disparities Among Adolescent and Young Adult (AYA) Survivors of Hodgkin and Non-Hodgkin Lymphoma
• 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.

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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Blood

• Sampling Method: Non-Probability Sample
• Study Population: Patients with treated Hodgkin lymphoma or Non-Hodgkin lymphoma across the United States

Condition

• Hodgkin Lymphoma
• Non-Hodgkin Lymphoma

Intervention

• 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

Study Groups/Cohorts

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.

Interventions:

• Procedure: Biospecimen Collection
• Other: Quality-of-Life Assessment
• Other: Questionnaire Administration

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 18, 2023): 2000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 9, 2028
• Estimated Primary Completion Date: April 9, 2028 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: United States

Administrative Information

• NCT Number: 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 )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
• Original Responsible Party: Same as current
• Current Study Sponsor: ECOG-ACRIN Cancer Research Group
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Bradley J Zebrack; ECOG-ACRIN Cancer Research Group

• PRS Account: Eastern Cooperative Oncology Group
• Verification Date: February 2024