Effect of a family-involvement combined aerobic and resistance exercise protocol on cancer-related fatigue in patients with breast cancer during postoperative chemotherapy: study protocol for a quasi-randomised controlled trial.

Introduction: Cancer-related fatigue (CRF) is one of the most common and debilitating side effects experienced by patients with breast cancer (BC) during postoperative chemotherapy. Family-involvement combined aerobic and resistance exercise has been introduced as a promising non-pharmacological intervention for CRF symptom relief and improving patients' muscle strength, exercise completion, family intimacy and adaptability and quality of life. However, evidence for the practice of home participation in combined aerobic and resistance exercise for the management of CRF in patients with BC is lacking.

Methods And Analysis: We present a protocol for a quasi-randomised controlled trial involving an 8-week intervention. Seventy patients with BC will be recruited from a tertiary care centre in China. Participants from the first oncology department will be assigned to the family-involvement combined aerobic and resistance exercise group (n=28), while participants from the second oncology department will be assigned to the control group that will receive standard exercise guidance (n=28). The primary outcome will be the Piper Fatigue Scale-Revised (R-PFS) score. The secondary outcomes will include muscle strength, exercise completion, family intimacy and adaptability and quality of life, which will be evaluated by the stand-up and sit-down chair test, grip test, exercise completion rate, Family Adaptability and Cohesion Scale, Second Edition-Chinese Version (FACESⅡ-CV) and Functional Assessment of Cancer Therapy -Breast (FACT-B) scale. Analysis of covariance will be applied for comparisons between groups, and paired t-tests will be used for comparison of data before and after exercise within a group.

Ethics And Dissemination: This study has been approved by the Ethics Committee of the First Affiliated Hospital of Dalian Medical University (PJ-KS-KY-2021-288). The results of this study will be published via peer-reviewed publications and presentations at conferences.

Trail Registration Number: ChiCTR2200055793.