Differences between health outcomes, participation/adoption, and cost-effectiveness of home-based (HOME) interventions and supervised group-based training (GROUP) in men with prostate cancer (PC) on androgen deprivation therapy (ADT) are currently unknown.
The objective of this study was to assess the clinical efficacy, adherence, and cost-effectiveness of HOME versus GROUP in men on ADT for PC.
This was a multicentre, 2-arm non-inferiority randomized controlled trial and companion cost-effectiveness analysis. Men with PC on ADT were recruited from August 2016 to March 2020 from four Canadian centres and randomized 1:1 to GROUP or HOME. All study participants engaged in aerobic and resistance training four to five days weekly for six months. Fatigue [Functional Assessment of Cancer Therapy-Fatigue (FACT-F)] and functional endurance [6-min walk test (6MWT)] at six months were the co-primary outcomes. Secondary outcomes included quality of life, physical fitness, body composition, blood markers, sedentary behaviour, and adherence. Between-group differences in primary outcomes were compared to margins of 3 points for FACT-F and 40 m for 6MWT using a Bayesian analysis of covariance (ANCOVA). Secondary outcomes were compared with ANCOVA, Costs included Ministry of Health costs, program costs, patient out-of-pocket, and time costs.
#NCT02834416.
Thirty-eight participants (mean [standard deviation (SD)] age, 70 [9.0] years) were enrolled (GROUP n = 20; HOME n = 18). There was an 89.8% probability that HOME was non-inferior to GROUP for both fatigue and functional endurance and a 9.5% probability that HOME reduced fatigue compared to GROUP (mean [SD] change, 12.1 [8.1] vs 3.6 [6.1]; p = 0.040) at six months. Adherence was similar among study arms. HOME was cost-saving (mean difference: -$4122) relative to GROUP.
A HOME exercise intervention appears non-inferior to GROUP for fatigue and functional endurance and requires fewer resources to implement. HOME appears to ameliorate fatigue more than GROUP, but has comparable effects on other clinically relevant outcomes. Although limited by sample size and attrition, these results support further assessment of home-based programs.
Journal of geriatric oncology. 2023 Nov 15 [Epub ahead of print]
Shabbir M H Alibhai, Efthymios Papadopoulos, Daniel Santa Mina, Paul Ritvo, George Tomlinson, Catherine M Sabiston, Sara Durbano, Karen E Bremner, James Chiarotto, Andrew Matthew, Padraig Warde, Meagan O'Neill, S Nicole Culos-Reed
Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada; Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada; Department of Medicine, University Health Network, Toronto, ON, Canada. Electronic address: ., School of Kinesiology, Louisiana State University, Baton Rouge, LA, USA., Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada., Department of Psychology, School of Kinesiology and Health Science, York University, Toronto, ON, Canada., Department of Medicine, University Health Network, Toronto, ON, Canada., Department of Medicine, Division of Hematology/Oncology, Scarborough Health Network, Scarborough, ON, Canada., Department of Surgical Oncology, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada., Faculty of Kinesiology, University of Calgary, Calgary, AB, Canada; Department of Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
PubMed http://www.ncbi.nlm.nih.gov/pubmed/37976654
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