Department of Nursing, First Affiliated Hospital of Dalian Medical University, Dalian, China.
Qiqihar Medical College, Qiqihar, Heilongjiang, China.
BMJ Open. 2023 Mar 30;13(3):e064850. doi: 10.1136/bmjopen-2022-064850.
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.
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.
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.
ChiCTR2200055793.
癌症相关疲劳（CRF）是乳腺癌（BC）患者在术后化疗期间最常见和最具衰弱性的副作用之一。家庭参与的结合有氧和抗阻运动已被引入作为缓解 CRF 症状的一种有前途的非药物干预措施，可以提高患者的肌肉力量、运动完成率、家庭亲密性和适应性以及生活质量。然而，缺乏关于家庭参与结合有氧和抗阻运动来管理 BC 患者 CRF 的实践证据。
我们提出了一项包含 8 周干预的半随机对照试验方案。将从中国一家三级护理中心招募 70 名 BC 患者。第一肿瘤科的参与者将被分配到家庭参与的结合有氧和抗阻运动组（n=28），而第二肿瘤科的参与者将被分配到对照组，对照组将接受标准运动指导（n=28）。主要结局将是 Piper 疲劳量表修订版（R-PFS）评分。次要结局将包括肌肉力量、运动完成率、家庭亲密性和适应性以及生活质量，将通过站立和坐下椅子测试、握力测试、运动完成率、家庭适应性和凝聚力量表第二版-中文版（FACESⅡ-CV）和癌症治疗功能评估-乳房（FACT-B）量表进行评估。组间比较将应用协方差分析，组内比较将应用配对 t 检验。
本研究已获得大连医科大学附属第一医院伦理委员会的批准（PJ-KS-KY-2021-288）。本研究的结果将通过同行评议的出版物和会议上的演讲发表。
ChiCTR2200055793。
