Barriers and Facilitators to Adolescent and Young Adult Cancer Trial Enrollment: NCORP Site Perspectives

Abstract

Background Although it is well documented that adolescents and young adults (AYAs) with cancer have low participation in cancer clinical trials (CCTs), the underlying reasons are not well understood. We utilized the NCI Community Oncology Research Program (NCORP) network to identify barriers and facilitators to AYA CCT enrollment, and strategies to improve enrollment at community-based and minority/underserved sites. Methods We performed one-on-one semi-structured qualitative interviews with stakeholders (NCORP Site Principle Investigators, NCORP Administrators, Physicians involved in enrollment, Lead Clinical Research Associates or Clinical Research Nurses, Nurse Navigators, Regulatory Research Associates, Patient Advocates) in the AYA CCT enrollment process. NCORP sites that included high- and low-AYA enrolling affiliate sites and were diverse in geography and department representation (eg, pediatrics, medical oncology) were invited to participate. All interviews were recorded and transcribed. Themes related to barriers and facilitators and strategies to improve enrollment were identified. Results We conducted 43 interviews across 10 NCORP sites. Eleven barriers and 13 facilitators to AYA enrollment were identified. Main barriers included perceived limited trial availability and eligibility, physician gatekeeping, lack of provider and research staff time, and financial constraints. Main facilitators and strategies to improve AYA enrollment included having a patient screening process, physician endorsement of trials, an “AYA champion” on site, and strong communication between medical and pediatric oncology. Conclusions Stakeholders identified several opportunities to address barriers contributing to low AYA CCT enrollment at community-based and minority/underserved sites. Results of this study will inform development and implementation of targeted interventions to increase AYA CCT enrollment.

A qualitative study of barriers and facilitators to adolescents and young adults’ participation in cancer clinical trials: Oncologist and patient perspectives

“…Additionally, patient navigators and psychologists can be particularly helpful to AYAs who are primary caregivers and may be less compliant with cancer treatment or even refuse to participate in a CT 40 . A study from the National Cancer Institute Community Oncology Research Program identified an “AYA champion” who prioritizes opening of AYA CTs, involves AYAs in the CT process, and integrates pediatric and adult oncologists as main facilitator for AYA participation in CTs 7,27,32,41 …”

“…Research Program identified an "AYA champion" who prioritizes opening of AYA CTs, involves AYAs in the CT process, and integrates pediatric and adult oncologists as main facilitator for AYA participation in CTs. 7,27,32,41 Finally, fertility concerns were described by several oncologists (but not AYAs) as a potential deterrent to CT enrollment, particularly among female AYAs. Until recently there were no standard guidelines for fertility preservation, an expensive procedure often not covered by health insurance.…”

“…In the United States, while 40%–60% of children (≤14 years) participate in CTs, approximately 15% of AYAs are enrolled 2 . Physician and institutional factors along with patient's educational, psychological, and socioeconomic barriers have been suggested to explain the lower AYA participation in CTs 3,5–8 . In addition, many AYAs are excluded from pediatric or adult trials due to strict age‐related eligibility criteria (e.g., pharmaceutical trials with 18 years old as the minimum age limit) 9 .…”

“…2 Physician and institutional factors along with patient's educational, psychological, and socioeconomic barriers have been suggested to explain the lower AYA participation in CTs. 3,[5][6][7][8] In addition, many AYAs are excluded from pediatric or adult trials due to strict age-related eligibility criteria (e.g., pharmaceutical trials with 18 years old as the minimum age limit). 9 Furthermore, AYAs with cancer have particular lifestyle behaviors, educational and work factors that influence their ability to participate in CTs.…”

Comparing Barriers and Facilitators to Adolescent and Young Adult Clinical Trial Enrollment Across High- and Low-Enrolling Community-Based Clinics

“…We recently conducted a multi-site, qualitative study to overcome the limitations of these previous studies, and identified barriers and facilitators to AYA CCT enrollment at 5 NCI Community Oncology Research Program (NCORP) sites. 16 The NCORP currently comprises 46 sites (32 community sites, 14 minority/underserved sites). Each NCORP site is a network of multiple community-based clinics, referred to as affiliate sites.…”