A semi-quantitative survey of older adults to assess barriers to participation in early phase clinical trials (EPCTs)

Abstract

8086 Background: The underrepresentation of older adults in EPCTs severely limits knowledge of drug pharmacology, treatment toxicity and efficacy in this population. We conducted a survey of adults aged 65+ years to describe the prevalence of patient-perceived barriers to participation in EPCTs and to identify factors important to older adults when deciding whether an experimental treatment option is acceptable. Methods: Subjects aged 65+ years with advanced solid tumors who had received prior chemotherapy were recruited from private medical oncology offices affiliated with the University of Colorado Comprehensive Cancer Center and Moffitt Cancer Center clinical research networks. Face-to-face interviews were conducted. Results: To date 219 subjects (median age 74 years (range, 65–89)) have been interviewed. One hundred thirty-six (62%, (95% C.I. 55–69)) subjects endorsed at least 1 barrier to participating in EPCTs. The most commonly reported barriers included difficulty getting to the university to participate in an EPCT (N=73, 33% (95% C.I., 27–40)), concern about being experimented on (N=43, 20% (95% C.I., 15–26)), loss of continuity with their oncologist (N=40, 18% (95% C.I., 13–24)) and adequacy of insurance coverage (N=22, 10% (95% C.I., 6–15)). When deciding whether to participate in an EPCT, 212 (97%) of subjects considered the endorsement of their oncologist to be very important, while only 24 (11%) considered information from the Internet to be very important. Possible benefits of experimental treatment reported to be very important included better symptoms (N=208, 95%) and living longer (N=201, 92%). When considering the possible impact of treatment side effects, subjects considered the following very important: being hospitalized (N=130, 59%), needing more care from family or friends (N=130, 59%), and not being able to care for a spouse or family member (N=112, 51%). Conclusion: The majority of older adults seen in private practices face barriers to participating in an EPCT at a local university. These results have been used to formulate a multifocal, targeted intervention to increase accrual of older adults on EPCTs. No significant financial relationships to disclose.