Wei Ran, Cai Yingjie, Guo Yufei, Liu Yuzhu, Cheng Huiyan, Li Mi, Shi Tieying
Department of Nursing, First Affiliated Hospital of Dalian Medical University, Dalian, China.
Fourth Affiliated Hospital of China Medical University, Shenyang, China.
BMJ Open. 2025 Aug 12;15(8):e095118. doi: 10.1136/bmjopen-2024-095118.
Agents used in antitumour therapy have toxic effects on the cardiovascular system of breast cancer (BC) patients, increasing the risk of cardiovascular disease, which has become the most common non-cancer cause of death in BC patients. Exercise can effectively prevent or reduce the occurrence of cardiotoxicity, however, most BC patients have low levels of physical activity. The Health Action Process Approach (HAPA) model has been successfully applied to encourage patients to adhere to physical exercise. This study aims to explore the impact of exercise interventions based on the HAPA model on the monitoring indicators related to cardiotoxicity in BC patients during chemotherapy, aiming to prevent cardiotoxicity in BC patients and improve their physical activity level, exercise self-efficacy, exercise social support and exercise compliance.
In a protocol for a quasi-randomised controlled trial involving a 4-month intervention, 62 patients with BC will be recruited from a tertiary care centre in China. Participants from the first oncology department will be assigned to the HAPA model-based exercise intervention group (n=31), while participants from the second oncology department will be assigned to the control group that will receive standard exercise guidance (n=31). The primary outcome will be the incidence of cardiotoxicity assessed by Electrocardiogram (ECG). The secondary outcomes will include physical activity level, exercise self-efficacy, exercise social support and exercise compliance, which will be evaluated by the short form of the International Physical Activity Questionnaire (IPAQ-SF), Self-Efficacy for Exercise Scale (SEE), Social Support Scale for Exercise (SSSE), and percentage of achieving the recommended total time of exercise per week. The chi-square test or Mann-Whitney U tests will be applied to compare the differences in ECG results and exercise compliance between the two groups. To evaluate the effect of exercise intervention on IPAQ-SF, SSE and SSSE, repeated measures ANOVA will be employed to examine the group-by-time interactions and main effects.
This study has been approved by the Ethics Committee of the First Affiliated Hospital of Dalian Medical University (PJ-KS-KY-2024-267(X)). The results of this study will be published via peer-reviewed publications and presentations at conferences.
ChiCTR2400090672.
用于抗肿瘤治疗的药物对乳腺癌（BC）患者的心血管系统有毒性作用，增加了心血管疾病的风险，而心血管疾病已成为BC患者最常见的非癌症死亡原因。运动可以有效预防或减少心脏毒性的发生，然而，大多数BC患者的身体活动水平较低。健康行动过程方法（HAPA）模型已成功应用于鼓励患者坚持体育锻炼。本研究旨在探讨基于HAPA模型的运动干预对BC患者化疗期间心脏毒性相关监测指标的影响，旨在预防BC患者的心脏毒性，提高其身体活动水平、运动自我效能、运动社会支持和运动依从性。
在一项为期4个月干预的半随机对照试验方案中，将从中国一家三级护理中心招募62例BC患者。来自第一肿瘤科室的参与者将被分配到基于HAPA模型的运动干预组（n = 31），而来自第二肿瘤科室的参与者将被分配到接受标准运动指导的对照组（n = 31）。主要结局将是通过心电图（ECG）评估的心脏毒性发生率。次要结局将包括身体活动水平、运动自我效能、运动社会支持和运动依从性，将通过国际体力活动问卷简表（IPAQ-SF）、运动自我效能量表（SEE）、运动社会支持量表（SSSE）以及达到每周推荐运动总时间的百分比进行评估。将应用卡方检验或曼-惠特尼U检验来比较两组之间ECG结果和运动依从性的差异。为了评估运动干预对IPAQ-SF、SSE和SSSE的影响，将采用重复测量方差分析来检验组×时间交互作用和主效应。
本研究已获得大连医科大学附属第一医院伦理委员会批准（PJ-KS-KY-2024-267(X)）。本研究结果将通过同行评审出版物和在会议上发表演讲的方式公布。
ChiCTR2400090672。
