八段锦锻炼对中国上海接受雄激素剥夺治疗的前列腺癌患者癌因性疲乏的影响：一项随机对照试验研究方案。
Effects of Baduanjin exercise on cancer-related fatigue in patients with prostate cancer treated with androgen deprivation therapy in Shanghai, China: a study protocol for a randomised controlled trial.
机构信息
School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.
出版信息
BMJ Open. 2024 Nov 13;14(11):e092363. doi: 10.1136/bmjopen-2024-092363.
INTRODUCTION
Cancer-related fatigue (CRF) is one of the most common and painful symptoms in patients with prostate cancer (PCa). Moreover, PCa patients who receive the androgen deprivation therapy (ADT) are more likely to develop CRF. Baduanjin exercise has been shown to improve CRF in some cancers. However, such effects have not been verified in patients with PCa treated with the ADT. So, this study was designed as a randomised controlled trial (RCT) to explore the effects of Baduanjin exercise on CRF in PCa patients treated with the ADT.
METHODS AND ANALYSIS
This study will be a single-centre, assessor and statistician blinded, RCT consisting of a 12 week intervention and 12 week follow-up. Patients with PCa who meet the inclusion criteria will be recruited from Shanghai Hudong Hospital. Participants will be randomly assigned to Baduanjin exercise group (n=42) and the control group (n=42), performing 12 weeks of Baduanjin exercise or reeiving the standard care. The primary outcome will be the clinical effect of Baduanjin exercise on CRF in PCa patients, which will be measured using the Piper Fatigue Self-Assessment (PFS) scale, a multidimensional measure of CRF using three different dimensions: somatic, emotional and cognitive. The secondary outcome will be the clinical effect of the Baduanjin exercise on the patient's level of fatigue, sleep, depression and life quality at the time, which will be assessed by the Brief Fatigue Inventory (BFI), the Pittsburgh Sleep Quality Index (PSQI), the Beck Depression Inventory (BDI) and the Functional Assessment of Cancer Therapy-Prostate (FACT-P).
ETHICS AND DISSEMINATION
This study has been approved by Shanghai Hudong Hospital Ethics Committee, Shanghai province (2022 SHHDKY08). The trial results will be submitted to conferences and peer-reviewed journals.
TRAIL REGISTRATION NUMBER
ChiCTR2300074293.
简介
癌症相关疲劳（CRF）是前列腺癌（PCa）患者最常见和最痛苦的症状之一。此外，接受雄激素剥夺治疗（ADT）的 PCa 患者更有可能出现 CRF。八段锦运动已被证明可改善某些癌症患者的 CRF。然而，这种效果尚未在接受 ADT 治疗的 PCa 患者中得到验证。因此，本研究设计为一项随机对照试验（RCT），旨在探讨八段锦运动对接受 ADT 治疗的 PCa 患者 CRF 的影响。
方法与分析
本研究将是一项单中心、评估者和统计师盲法、RCT，包括 12 周干预和 12 周随访。符合纳入标准的 PCa 患者将从上海沪东医院招募。参与者将被随机分配到八段锦运动组（n=42）和对照组（n=42），分别进行 12 周的八段锦运动或接受标准护理。主要结局将是八段锦运动对 PCa 患者 CRF 的临床疗效，使用 Piper 疲劳自评量表（PFS）进行测量，这是一种使用三个不同维度：躯体、情绪和认知来衡量 CRF 的多维测量方法。次要结局将是八段锦运动对患者疲劳、睡眠、抑郁和生活质量的临床疗效，将通过简短疲劳量表（BFI）、匹兹堡睡眠质量指数（PSQI）、贝克抑郁量表（BDI）和癌症治疗功能评估-前列腺（FACT-P）进行评估。
伦理和传播
本研究已获得上海沪东医院伦理委员会、上海省批准（2022 SHHDKY08）。试验结果将提交给会议和同行评议期刊。
试验注册号
ChiCTR2300074293。
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