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

Social Genomic Mechanisms of Health Disparities Among Adolescent and Young Adult (AYA) Cancer Survivors

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06002828
Enrollment
2000
Registered
2023-08-21
Start date
2023-10-13
Completion date
2027-03-31
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia, Hodgkin Lymphoma, 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 or leukemia. 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 and health and treatment information from cancer survivors of Hodgkin or non-Hodgkin lymphoma or leukemia 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 evaluate the impact of social-environmental risk factors on changes in Charlson Comorbidity Index over time for adolescent and young adult cancer survivors. OUTLINE: This is an observational study. Patients complete questionnaires and undergo collection of blood samples on study.

Interventions

OTHERNon-Interventional Study

Non-interventional study

Sponsors

ECOG-ACRIN Cancer Research Group
Lead SponsorNETWORK
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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) or leukemia (acute lymphoblastic leukemia \[ALL\] only) * 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 or leukemia (ALL) must have been within 3 years 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 or leukemia * 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

Design outcomes

Primary

MeasureTime frameDescription
Impact of social-environmental risk factors on changes in Charlson Comorbidity Index (CCI)Through Study Completion, up to 2 years.Will fit Conway-Maxwell-Poisson mixed effects models with a log link to evaluate the impact of social-environmental risk factors on changes in CCI over time. Estimates will be reported as rate ratios (and 95% confidence intervals) on the link scale, with model-based marginal means by visit to aid interpretation on the count scale. Models will be fit by maximum likelihood using all observed visits; targeted diagnostics will assess dispersion, fit, and influence.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORBradley J Zebrack

ECOG-ACRIN Cancer Research Group

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026