Development and validation of a Tai chi intervention protocol for managing the fatigue-sleep disturbance-depression symptom cluster in female breast cancer patients

•The fatigue-sleep disturbance-depression symptom cluster (FSDSC) is commonly seen in breast cancer (BC) patients.•This study was conducted to develop and validate a tai chi intervention protocol for FSDSC management in BC patients.•The study design was guided by the Medical Research Council Framework for Developing and Evaluating Complex Interventions.•The tai chi protocol is supported by practice guidelines, systematic review evidence, theories, and experts’ agreement.•Feasibility of the tai chi intervention will be further examined in a pilot clinical trial. To develop an evidence-based tai chi intervention protocol for managing the fatigue-sleep disturbance-depression symptom cluster (FSDSC) in breast cancer (BC) patients. The Medical Research Council (MRC) Framework for Developing and Evaluating Complex Interventions (the MRC framework) was utilized to guide the study design. This study focused on Phase І of the MRC framework—the development of the intervention—to develop an evidence-based tai chi intervention protocol for managing the FSDSC in BC patients based on existing research evidence, theories, practice standards/guidelines, and experts’ consensus. An extensive literature search was performed to identify current systematic reviews, theories, and practice standards/guidelines that can be utilized to inform the intervention dosage and techniques of tai chi and practice instructions. Content validity assessment was also conducted to assess the content validity of the tai chi protocol through expert panel consensus. The content validity index (CVI) was calculated to identify whether the intervention required further refinement. The components of the tai chi protocol were identified by current research evidence and relevant practice standards/guidelines, including the selection of an appropriate tai chi modality and intensity and the duration of the intervention. The Easy 8 form Yang-style tai chi was selected based on the guidelines of the National Comprehensive Cancer Network, the American College of Sports Medicine, and China’s State Commission for Physical Culture and Sports. The intensity and duration of the tai chi intervention were scheduled, respectively, twice per week, with each session lasting about one hour, for eight weeks based on the current systematic review evidence on traditional Chinese exercise for the alleviation of cancer-related symptoms. The practise techniques of tai chi were identified from practise standards released by t