Effect of Baduanjin Exercise Intervention on Cognitive Function and Quality of Life in Women With Breast Cancer Receiving Chemotherapy: Study Protocol of A Randomized Controlled Trial

Abstract Background: Cancer-related cognitive impairments (CRCI) are frequently reported by cancer patients before and after medical treatment. However, there are no effective interventions to or manage cognitive problem for women with breast cancer. This pilot study was designed to evaluate the protective effect of Baduanjin exercise on cognitive function and cancer-related symptoms in women with early-stage breast cancerundergoing chemotherapy. Method/design: A single-blinded, randomized controlled trial was designed. The trail will recruit 70 patients with early-stage breast cancer scheduled to receive chemotherapy from Shanghai in China. All participants will be randomized(1:1) to receive either supervised Baduanjin exercise intervention (at least 5 times/week and 30min for each time) plus usual care or usual care alone for three months. The effect of Baduanjin exercise intervention will be evaluated by outcome measures such as subjective and objective cognitive function, symptoms (fatigue, depressive symptoms, anxiety) and health-related quality of life at baseline(T0), 8 weeks(T1) and 12 weeks(T3). Primary cognitive outcomes will be reported descriptively while effect sizes and 95% confidence intervals (CIs) will be calculated for cognitive measures. The collected data will be analysed using an intention-to-treat principle. Discussion: This study is the first-known randomized clinical trial to investigate whether Baduanjin exercise plus usual care superior to usual care alone on cognitive function in women with breast cancer receiving chemotherapy. If possible, Baduanjin exercise will be a potential non-pharmacological intervention to manage cognitive function and promote survivorship care among breast cancer survivors.Trial registration: Chinese Clinical Trial Registry(ChiCTR), ID: ChiCTR 2000033152. Registered on 22 May 2020.