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

Recruiting

• Conditions: Hodgkin Lymphoma; Non-Hodgkin Lymphoma

• Registration Number: NCT06002828
• Lead Sponsor: ECOG-ACRIN Cancer Research Group

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 Timeline

• Study First Submitted: 2023-08-14
• Study First Submitted QC: 2023-08-18
• Study First Posted: 2023-08-21
• Study Start: 2023-10-13
• Status Verified: 2024-06
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-22
• Primary Completion: 2030-02-01
• Study Completion: 2030-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease free survival (DFS)	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.
Comorbidities (including symptoms, late effects)	Up to 2 years	Will be assessed using Charlson Comorbidity Index (Patient version) National Cancer Institute Common Toxicity Criteria for Adverse Events.
Overall survival (OS)	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.

Secondary Outcome Measures

Name	Time	Method
Quality of life collected via PROMIS-29 v2	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.

Trial Locations

Locations (427)

Kingman Regional Medical Center; 🇺🇸 Kingman, Arizona, United States

PCR Oncology; 🇺🇸 Arroyo Grande, California, United States

Advocate Outpatient Center - Aurora; 🇺🇸 Aurora, Illinois, United States

Mercy Health - Paducah Cancer Center; 🇺🇸 Paducah, Kentucky, United States

Henry Ford Health Saint John Hospital; 🇺🇸 Detroit, Michigan, United States

Henry Ford Saint John Hospital - Academic; 🇺🇸 Grosse Pointe Woods, Michigan, United States

MyMichigan Medical Center Saginaw; 🇺🇸 Saginaw, Michigan, United States

MyMichigan Medical Center Tawas; 🇺🇸 Tawas City, Michigan, United States

Henry Ford Madison Heights Hospital - Breast; 🇺🇸 Warren, Michigan, United States

Carson Tahoe Regional Medical Center; 🇺🇸 Carson City, Nevada, United States

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