(UroToday.com) In contrast to cancer pharmaceuticals, recruitment to exercise intervention randomized controlled trials (RCT) is commonly low, which undermines study power and delays study treatment. In fact, RCT recruitment rates in exercise oncology often are less than 40%, and adherence for patients who do enroll is poor. In this poster, Dr. Alibhai and colleagues explore whether a preference-based trial, which allows the patient to choose the arm they are allocated to, would address one critical barrier to RCT enrollment. Specifically, they ran a two-arm multicenter preference trial in parallel with a 2-arm multicenter RCT, the latter of which randomized patients on ADT for prostate cancer to exercise in a group class versus home setting (NCT03335631). The “group” arm included 3 classes per week in groups of 4-8 patients supervised by an exercise professional as well as two unsupervised sessions. The “home” arm consisted of 5 unsupervised workouts per week with complimentary provided equipment and access to a health coach once a week. Outcomes were measured by the FACT-F scale and the 6-minute walk test distance. The schema is shown below.
Of 260 patients who were considered for enrollment in either the PREF or RCT studies, 27.8% of patients elected for the PREF trial after declining the RCT, suggesting that randomization was a substantial barrier to enrollment in the intervention. Patient demographics were similar between the PREF and RCT studies, and no statistically significant difference in outcome by FACT-F or 6-minute walk test were detected between the two trial formats. Furthermore, in the PREF trial, no statistically significant difference in outcome was detected between the group and home workout formats.
The authors concluded that patient preference for treatment arm allocation may expand enrollment in exercise oncology studies, and that home training seemed to have similar benefits with regards to functional endurance and fatigue as group training for men with prostate cancer receiving ADT.
Presented by: Shabbir M.H. Alibhai, MD, MSc, FRCPC, Professor in the Department of Medicine, the Institute of Health Policy Management and Evaluation, and the Institute of Medical Sciences at the University of Toronto, Canada
Written by: Alok K. Tewari, MD, PhD, medical oncologist at Dana-Farber Cancer Institute, @aloktewar on Twitter during the 2022 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium, Thursday Feb 17 – Saturday Feb 19, 2022