Influencing Referral of Adolescents and Young Adults With Cancer to Sites With Higher Rates of Trial Enrollment

Abstract

Adolescents and young adults (AYAs) have lower rates of clinical trial enrollment than younger or older patients with cancer. Multiple approaches to change policy and practice need to be used to improve this statistic. This article examines the option of increasing referral to 3 types of centers that are known to have relatively higher rates of enrollment of AYAs: pediatric cancer centers, AYA oncology programs, and National Cancer Institute-designated cancer centers. There are reasonable challenges to changing referral patterns, and more research, as well as education of those diagnosing AYAs, is required.

Clinical research participation among adolescent and young adults at an NCI-designated Comprehensive Cancer Center and affiliated pediatric hospital

“…Taken together, these results are supportive of prior suggestions that referral to NCI-designated and pediatric cancer centers may impact AYA clinical trial participation [9]. Given evidence that trial participation is associated with improvements in 5-year survival rates, such an approach may be paramount to accelerating treatment advances for this historically under-represented subset of cancer survivors [7].…”

“…Finally, strategies for fostering clinical trial availability and AYA enrollment in the USA have been published previously with in-depth discussions of both local and systemic approaches, including but not limited to AYA medical education, development of AYA programs, and addressing referral patterns and expansion of national cooperative group initiatives [9, 10, 17, 18]. The proposed strategy of influencing referrals to cancer centers with AYA programs, NCI-designated centers or pediatric cancer centers may be a necessary but not sufficient approach to meeting the greater needs of AYAs with cancer.…”

“…Greater emphasis must be placed on community engagement as a key component to adequately reach a population of patients that are largely treated in community oncology settings. Opportunity for such engagement is greater than it has been previously with the establishment of the National Clinical Trials Network and NCI Community Oncology Research Program which is designed to help increase access to clinical research for populations like AYAs [9, 10, 18]. Interestingly, a recent examination of AYA enrollment on COG trials within the Community Clinical Oncology Program (CCOP now named NCI Community Oncology Research Program) found proportional AYA enrollments at CCOP sites to be lower than non-CCOP sites [19].…”

“…The University of Pittsburgh Cancer Institute and Children’s Hospital of Pittsburgh demonstrated improvements in AYA clinical trial enrollments after initiating an AYA oncology program that fosters collaboration between pediatric and medical oncologists and the opening of new AYA-relevant clinical trials via a joint Institutional Review Board [8]. Others have suggested a strategy for improving enrollment statistics for AYAs via influencing referrals to centers known to have relatively higher proportions of AYA enrollment including pediatric cancer centers, AYA oncology programs, and NCI-designated Cancer Centers [9]. Freyer and Seibel recently published a review of the “clinical trial gap” for AYAs, including a conceptual framework for research and discussion of how recent developments in the NCI-funded enterprise (e.g., National Clinical Trials Network and NCI Community Oncology Research Program) provide opportunity for improvement with emphasis on greater opportunity for trial enrollment in community oncology settings [10].…”

The Clinical Trials Gap for Adolescents and Young Adults with Cancer: Recent Progress and Conceptual Framework for Continued Research

“…As an alternative to being an NCTN group member and receiving per-case reimbursement for enrolling patients, qualified institutions may apply for funding as an NCORP member and be able to enroll patients onto any NCTN trial [34]. A facilitator for AYA accrual might be referral of more patients by community-based oncologists to higher-volume NCTN or NCORP sites [39], but distance and other resource limitations may still make travel impractical. Linkages between NCTN sites and community-based oncologists may represent another alternative, though this may not be feasible without addressing current federal regulations limiting where treatment on NCI-supported trials can be administered [40].…”