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A pilot feasibility randomized controlled trial adding behavioral counseling to supervised physical activity in prostate cancer survivors: behavior change in prostate cancer survivors trial (BOOST)
Trinh L, Kramer AF, Rowland K, Strom DA, Wong JN, McAuley E
Journal of Behavioral Medicine 2021 Apr;44(2):172-186
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: Yes; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

The purpose of this study was to evaluate the feasibility of delivering a supervised physical activity program plus standard exercise counseling (PA+EC) versus a supervised physical activity plus motivationally-enhanced behavioral counseling (PA+BC) in prostate cancer survivors. Secondary outcomes included objectively assessed PA, quality of life, body composition, cardiorespiratory fitness, cognitive functioning, and physical function. Twenty-six prostate cancer survivors were randomized to a 12-week supervised PA program plus standard exercise counseling or a 12-week supervised PA plus behavioral counseling based on the multi-process action control framework. Feasibility was determined through enrolment rate, measurement completion rate, loss-to-follow-up, adherence to the intervention, adverse events, and program evaluation items assessing burden and satisfaction. Of the 26 prostate cancer survivors enrolled (mean age 65.6 +/- 6.8), 96% completed the intervention. Measurement completion rates for the study measures were 88.5%. Adherence to the supervised PA sessions was 92% (completed 11/12 supervised PA sessions) and 100% (completed 12/12 supervised PA sessions) in the PA+EC and PA+BC group, respectively. Adherence to the home-based PA sessions was 70% (completed 7/10 home-based sessions) and 90% (completed 9/10 home-based sessions) in the PA+EC and PA+BC group, respectively. Overall, prostate cancer survivors were highly satisfied with the intervention components and found it rewarding, useful for research helping others, and useful for them personally. The patterns in the secondary outcomes were consistent with a positive impact of the intervention, favoring the PA+BC group. Preliminary evidence suggests that adding behavioral counseling to supervised PA in prostate cancer survivors may be feasible and result in better adherence to PA compared to exercise counseling alone, although additional refinement is needed. A combination of supervised and home-based PA may be feasible for behavior change in the self-management of prostate cancer. The study is registered with http://ClinicalTrials.gov (ID NCT03191968).

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