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

Overview

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.

Interventions

• Procedure Biospecimen Collection
  Undergo collection of blood samples
• Other Quality-of-Life Assessment
  Complete questionnaires
• Other Questionnaire Administration
  Complete questionnaires

Primary outcome measures

• 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]
• 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]
• Comorbidities (including symptoms, late effects) [Time frame: Up to 2 years]

Secondary outcome measures (1)

• Quality of life collected via PROMIS-29 v2 [Time frame: Up to 2 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 428 centers

• Anchorage Associates in Radiation Medicine — Anchorage
• Anchorage Radiation Therapy Center — Anchorage
• Alaska Breast Care and Surgery LLC — Anchorage
• Alaska Oncology and Hematology LLC — Anchorage
• Alaska Women's Cancer Care — Anchorage
• Anchorage Oncology Centre — Anchorage
• Katmai Oncology Group — Anchorage
• Providence Alaska Medical Center — Anchorage
• … and 420 more centers

Identifiers

NCT: NCT06002828 · EAQ211 · NCI-2022-05526 · EAQ211 · ECOG-ACRIN-EAQ211 · ECOG-ACRIN-EAQ211 · UG1CA189828

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗