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Barriers to Enrollment of Elderly Adults in Early-Phase Cancer Clinical Trials

University of Colorado Cancer Center and Colorado Health Outcomes Program, Aurora, CO; Moffitt Cancer Center, Tampa, FL.

Corresponding author: John F. Steiner, MD, MPH, Director, Colorado Health Outcomes Program, University of Colorado at Denver and Health Sciences Center, P.O. Box 6508, Campus Box F-443, Aurora, CO 80045; john.steiner{at}uchsc.edu

Purpose: To describe patient/family and logistical barriers to participation in university-based, early-phase cancer clinical trials for adults age 65 years, and to identify influences on their decisions to participate.

Participants and Methods: In-person surveys were administered to subjects age 65 years with advanced tumors who had received prior chemotherapy. Subjects were recruited from private medical oncology practices collaborating with the University of Colorado and Moffitt Cancer Center research networks.

Results: Three hundred individuals (51% age 65 to 74 and 49% age 75 or older) responded. Overall, 60% reported one or more barriers to participation in an early-phase trial; logistical barriers such as driving or time demands (34%) or reluctance to be treated at a university center (21%) were most common. Seniors age 75 or older were more reluctant to be treated at a university center (27% v 14%; P = .005), or concerned about loss of continuity with their primary oncologist (24% v 15%, P = .05). Older seniors were also significantly more reluctant than younger seniors to consider treatments with substantial nausea, vomiting, or fatigue. Older and younger seniors differed little in their preferred sources of information; both age groups emphasized the importance of the primary oncologist (100%), a nurse who provides experimental treatment (93%), other patients (83%) or acquaintances who had received experimental treatment (83%).

Conclusion: Potential strategies to overcome barriers to enrollment of seniors into early-phase trials include providing more information about trials to community oncologists and prospective enrollees and assisting these individuals in navigating logistical barriers to enrollment.

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