Evaluating the Impact of Social and Genetic Factors on Outcomes in Adolescent and Young Adult Cancer Survivors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorECOG-ACRIN Cancer Research Group
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
Patients with treated Hodgkin lymphoma or Non-Hodgkin lymphoma across the United States
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood samples
Quality-of-Life Assessment
Other interventionComplete questionnaires
Questionnaire Administration
Other interventionComplete questionnaires
Treatment groups
2,000 Participants
are divided into 1 treatment groupGroup A: Observational (questionnaires, biospecimen collection)3 interventions
Trial outcomes
Primary outcomes
1
Disease free survival (DFS)
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.
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 years2
Overall survival (OS)
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.
Time frame
From participant registration to the date of death or censored at the date of data collection, assessed up to 2 years3
Comorbidities (including symptoms, late effects)
Will be assessed using Charlson Comorbidity Index (Patient version) National Cancer Institute Common Toxicity Criteria for Adverse Events.
Time frame
Up to 2 yearsSecondary outcomes
1
Quality of life collected via PROMIS-29 v2
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.
Time frame
Up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
ECOG-ACRIN Cancer Research Group
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov