Grant Number:	5R01CA274484-03 Interpret this number
Primary Investigator:	Mack, Jennifer
Organization:	Dana-Farber Cancer Inst
Project Title:	Clinical Trial Enrollment Among Adolescents and Young Adults with Cancer
Fiscal Year:	2025

More than 70,000 adolescents and young adults (AYAs) are diagnosed with cancer in the United States (US) each year, and fewer than 10% enroll in clinical trials, reflecting far lower rates than seen in children and older adults. Yet AYAs with cancer who enroll in therapeutic clinical trials have improved survival and better adherence to long-term follow-up care during survivorship. In addition, clinical trial enrollment is essential to address inferior survival gains seen in recent decades for the AYA age group as a whole. Work in older adults has identified variation in clinical trial enrollment across the population. For example, select patient populations have limited geographic access to clinical trials, whereas others have concerns about whether trials are fairly designed to serve all patients. Previous work to examine clinical trial participation among AYAs has failed to examine trial perspectives across a broad population or the key barriers that stand in the way of enrollment to therapeutic trials. The proposed study will evaluate variation in enrollment to clinical trials among AYAs with cancer aged 12-29 years in 3 states: Louisiana, New Mexico, and Tennessee. We will focus on three key barriers to clinical trial enrollment among AYAs: structural barriers of trial availability and access, individual barriers such as financial concerns and beliefs about trials, and interpersonal barriers related to communication about trials between patients, family members, and oncologists. These areas have been identified in previous work in adults as remediable barriers to clinical trial enrollment with relevance to a broad population. Our aims are: Aim 1: To assess AYA trial availability and access in 3 states, including sources of variation in each across the AYA population. Using state cancer registry data and clinical trial availability data from ClinicalTrials.gov, we will identify available trials and AYA populations with limited trial access. Aim 2: To identify individual and interpersonal barriers to trial enrollment among AYAs with cancer. We will survey AYAs with cancer, caregivers, and oncologists to examine willingness to enroll in trials; interview AYAs to identify trial perspectives; and audiotape AYA-family-oncologist discussions to examine trial communication. Impact: At the end of this study, we will have identified key structural, individual, and interpersonal barriers to enrollment in clinical trials for AYAs in 3 states and prioritized areas for intervention. Our next step will be the development of targeted interventions to address identified barriers.





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