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The conduct of adequately powered trials comparing multiple complex interventions (such as exercise) faces challenges regarding time and resources. Laurien Buffart and colleagues showed that a novel adaptive trial design substantially reduced the sample size required to identify which exercise intervention was most effective to reduce chemotherapy treatment modifications in patients with breast cancer.
Multiple studies have shown that exercise during cancer treatment helps to maintain physical fitness and function, limit fatigue and enhance quality of life. However, the effects of exercise on clinical outcomes and the optimal exercise prescriptions are unclear. Conducting multi-arm trials in which different exercise programs are compared directly is often difficult as this generally requires large sample sizes. Adaptive trials can facilitate timely stopping of studies or early dropping of ineffective treatments. Using a Bayesian adaptive trial design, the researchers re-analysed data from the previously conducted PACES trial that was coordinated by the Netherlands Cancer Institute. Results from this trial showed that combined aerobic and resistance exercise during chemotherapy treatment was effective in prevent chemotherapy treatment modifications. The researchers now showed that decisions on the best exercise program could have been made much earlier, than after the 230 patients that were originally included in the trial. Buffart now uses this adaptive study design to examine which exercise program is most effective to prevent treatment modifications in patients with metastatic colorectal cancer.
Laurien Buffart, department of Medical BioSciences, in collaboration with biostatisticians Peter van de Ven (UMC Utrecht) and Hans Berkhof (Amsterdam UMC) and researchers from the Netherlands Cancer Institute published the results in the Journal of Clinical Epidemiology on 26 May 2023.
Read the publication here
Buffart LM, Bassi A, Stuiver MM, Aaronson NK, Sonke GS, Berkhof J, van de Ven PM. A Bayesian adaptive decision-theoretic approach can reduce the sample sizes for multi-arm exercise oncology trials. J Clin Epidemiol 2023 May 26;S0895-4356(23)00132-4.
