Accrual and retention of diverse patients in psychosocial cancer clinical trials

Grace Ann Hanvey; Adaixa Padron; Elizabeth L Kacel; Gabriel Cartagena; Kelsey C Bacharz; Christina S McCrae; Michael E Robinson; Lori B Waxenberg; Michael H Antoni; Richard B Berry; Gregory S Schultz; Jacqueline Castagno; Deidre B Pereira

doi:10.1017/cts.2022.380

Accrual and retention of diverse patients in psychosocial cancer clinical trials

J Clin Transl Sci. 2022 Apr 1;6(1):e45. doi: 10.1017/cts.2022.380. eCollection 2022.

Affiliations

¹ Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA.
² Department of Psychology, University of Miami, Coral Gables, FL, USA.
³ Division of Pulmonary, Critical Care, and Sleep Medicine, University of Florida, Gainesville, FL, USA.
⁴ Department of Obstetrics and Gynecology, University of Florida, Gainesville, FL, USA.

Abstract

Background: Minority and older adult patients remain underrepresented in cancer clinical trials (CCTs). The current study sought to examine sociodemographic inequities in CCT interest, eligibility, enrollment, decline motivation, and attrition across two psychosocial CCTs for gynecologic, gastrointestinal, and thoracic cancers.

Methods: Patients were approached for recruitment to one of two interventions: (1) a randomized control trial (RCT) examining effects of a cognitive-behavioral intervention targeting sleep, pain, mood, cytokines, and cortisol following surgery, or (2) a yoga intervention to determine its feasibility, acceptability, and effects on mitigating distress. Prospective RCT participants were queried about interest and screened for eligibility. All eligible patients across trials were offered enrollment. Patients who declined yoga intervention enrollment provided reasons for decline. Sociodemographic predictors of enrollment decisions and attrition were explored.

Results: No sociodemographic differences in RCT interest were observed, and older patients were more likely to be ineligible. Eligible Hispanic patients across trials were significantly more likely to enroll than non-Hispanic patients. Sociodemographic factors predicted differences in decline motivation. In one trial, individuals originating from more urban areas were more likely to prematurely discontinue participation.

Discussion: These results corroborate evidence of no significant differences in CCT interest across minority groups, with older adults less likely to fulfill eligibility criteria. While absolute Hispanic enrollment was modest, Hispanic patients were more likely to enroll relative to non-Hispanic patients. Additional sociodemographic trends were noted in decline motivation and geographical prediction of attrition. Further investigation is necessary to better understand inequities, barriers, and best recruitment practices for representative CCTs.

Keywords: Cancer; clinical trials; health disparities; recruitment; retention.