Baduanjin Mind-Body Exercise for Cancer-Related Fatigue: Protocol for a Remotely Delivered Randomized Wait-List Controlled Feasibility Study.

IF 2.9 3区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE
Sean Walsh, Kang Wang, Anderson Lam, Shihao Du, Yanbin Hu, Yu-Ting Sun, Elise Tcharkhedian, Evangeline Nikas, Gregory Webb, Eugene Moylan, Stephen Della-Fiorentina, Paul Fahey, Xin Shelley Wang, Ming Chen, Xiaoshu Zhu
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引用次数: 0

Abstract

Background: People living with a cancer diagnosis often experience cancer-related fatigue (CRF). Between 9% and 45% of people report CRF as moderate to severe, negatively impacting their quality-of-life (QOL). The evidence-base for managing CRF recommends exercise-related therapies over pharmaceutical interventions. One such exercise-like therapy is Baduanjin mind-body exercise (MBE), which has additional benefits. A remotely delivered program may further benefit people with CRF. The primary objective of this pilot will test study feasibility of a remotely delivered Baduanjin MBE exercise program for people living with CRF.

Methods: This is a randomized wait-list controlled pilot study and will take place in Sydney, Australia. Subject to informed consent, 40 adults with moderate CRF levels and receiving or previously received adjuvant chemotherapy, will undertake a home-based 8-week Baduanjin MBE program supported by online resources and instructors. The primary feasibility outcomes are recruitment, enrollment, retention, and adherence rates; and safety as measured by tolerance and adverse-event frequency. Clinical outcomes (eg, changes in CRF, QOL, and participant perceptions) are assessed at pre-intervention, week 1, week 4, week 8, and post-intervention. Analyses follows the Intent-to-Treat (all participants as per randomization) and per-protocol (participants adhering to the protocol). Missing data will be imputed from previous data entries and regression models may be tested to predict missing outcomes.

Discussion: To our knowledge, this is the first study evaluating the feasibility and effects of Baduanjin MBE on CRF using a remote delivery method. These feasibility data will inform a fully powered future trial investigating evidence of effect on CRF and QOL.Trial registration: Australian and New Zealand Clinical Trials Registry (ANZCTR 12623000177651).Ringgold ID: 651498 Chinese Medicine Centre.

八段锦身心锻炼法治疗癌症相关疲劳:远程交付随机候补名单对照可行性研究方案》。
背景:被诊断出患有癌症的人经常会感到与癌症相关的疲劳(CRF)。9%至 45% 的人报告中度至重度 CRF,这对他们的生活质量(QOL)产生了负面影响。控制 CRF 的证据基础建议采用运动疗法,而不是药物干预。八段锦身心锻炼疗法(MBE)就是一种类似运动的疗法,它还具有额外的益处。远程提供的计划可能会让 CRF 患者进一步受益。本试验的主要目的是测试为慢性阻塞性肺疾病患者远程提供八段锦身心锻炼计划的可行性:这是一项随机等待对照试验研究,将在澳大利亚悉尼进行。在获得知情同意的情况下,40 名患有中度 CRF 并正在接受或曾经接受过辅助化疗的成年人将在网上资源和指导员的支持下,参加为期 8 周的八段锦 MBE 居家锻炼计划。主要的可行性结果包括招募率、注册率、保留率和坚持率;以及通过耐受性和不良事件频率衡量的安全性。在干预前、第 1 周、第 4 周、第 8 周和干预后评估临床结果(如 CRF、QOL 和参与者看法的变化)。分析遵循意向治疗(所有参与者按随机分配)和按方案(参与者遵守方案)。缺失数据将从以前的数据条目中进行估算,并可能对回归模型进行测试,以预测缺失的结果:据我们所知,这是第一项使用远程交付方法评估巴端金 MBE 对 CRF 的可行性和效果的研究。这些可行性数据将为未来的全面试验提供信息,以调查对 CRF 和 QOL 的影响证据:试验注册:澳大利亚和新西兰临床试验注册中心(ANZCTR 12623000177651)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Integrative Cancer Therapies
Integrative Cancer Therapies 医学-全科医学与补充医学
CiteScore
4.80
自引率
3.40%
发文量
78
审稿时长
>12 weeks
期刊介绍: ICT is the first journal to spearhead and focus on a new and growing movement in cancer treatment. The journal emphasizes scientific understanding of alternative medicine and traditional medicine therapies, and their responsible integration with conventional health care. Integrative care includes therapeutic interventions in diet, lifestyle, exercise, stress care, and nutritional supplements, as well as experimental vaccines, chrono-chemotherapy, and other advanced treatments. Contributors are leading oncologists, researchers, nurses, and health-care professionals.
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