Western Sydney University, Penrith South, NSW, Australia.
University Malaya Medical Centre, Kuala Lumpur, Wilayah Persekutuan, Malaysia.
Integr Cancer Ther. 2024 Jan-Dec;23:15347354241252698. doi: 10.1177/15347354241252698.
Cancer-related fatigue and its associated symptoms of sleep disorder and depression are prevalent in cancer survivors especially among breast, lung, and colorectal cancer survivors. While there is no gold standard for treating cancer-related fatigue currently, studies of mind-body exercises such as Qigong have reported promise in reducing symptoms. This study was designed to evaluate the feasibility and effect of Guolin Qigong on cancer-related fatigue and other symptoms in breast, lung and colorectal cancer survivors while exploring their perceptions and experiences of Guolin Qigong intervention.
This is an open-label randomized controlled trial with 60 participants divided into 2 study groups in a 1:1 ratio. The intervention group will receive 12 weeks of Guolin Qigong intervention with a 4-week follow-up while control will receive usual care under waitlist. The primary outcome will be feasibility measured based on recruitment and retention rates, class attendance, home practice adherence, nature, and quantum of missing data as well as safety. The secondary subjective outcomes of fatigue, sleep quality and depression will be measured at Week-1 (baseline), Week-6 (mid-intervention), Week-12 (post-intervention), and Week-16 (4 weeks post-intervention) while an objective 24-hour urine cortisol will be measured at Week-1 (baseline) and Week-12 (post-intervention). We will conduct a semi-structured interview individually with participants within 3 months after Week-16 (4 weeks post-intervention) to obtain a more comprehensive view of practice adherence.
This is the first mixed-method study to investigate the feasibility and effect of Guolin Qigong on breast, lung, and colorectal cancer survivors to provide a comprehensive understanding of Guolin Qigong's intervention impact and participants' perspectives. The interdisciplinary collaboration between Western Medicine and Chinese Medicine expertise of this study ensures robust study design, enhanced participant care, rigorous data analysis, and meaningful interpretation of results. This innovative research contributes to the field of oncology and may guide future evidence-based mind-body interventions to improve cancer survivorship.
This study has been registered with ANZCTR (ACTRN12622000688785p), was approved by Medical Research Ethic Committee of University Malaya Medical Centre (MREC ID NO: 2022323-11092) and recognized by Western Sydney University Human Research Ethics Committee (RH15124).
癌症相关疲劳及其相关的睡眠障碍和抑郁症状在癌症幸存者中很常见，尤其是在乳腺癌、肺癌和结直肠癌幸存者中。虽然目前还没有治疗癌症相关疲劳的金标准，但气功等身心锻炼的研究报告称，这些锻炼在减轻症状方面有一定的效果。本研究旨在评估固林气功对乳腺癌、肺癌和结直肠癌幸存者的癌症相关疲劳及其他症状的可行性和效果，同时探讨他们对固林气功干预的看法和体验。
这是一项开放标签的随机对照试验，共有 60 名参与者按 1:1 的比例分为两组。干预组将接受 12 周的固林气功干预，同时进行 4 周的随访，而对照组将在候补名单下接受常规护理。主要结果将根据招募和保留率、课程出勤率、家庭练习依从性、缺失数据的性质和数量以及安全性来衡量可行性。次要主观结果，包括疲劳、睡眠质量和抑郁，将在第 1 周（基线）、第 6 周（干预中期）、第 12 周（干预后）和第 16 周（干预后 4 周）进行测量，而 24 小时尿液皮质醇将在第 1 周（基线）和第 12 周（干预后）进行测量。我们将在第 16 周（干预后 4 周）后 3 个月内对参与者进行单独的半结构化访谈，以更全面地了解实践依从性。
这是第一项关于固林气功对乳腺癌、肺癌和结直肠癌幸存者的可行性和效果的混合方法研究，为全面了解固林气功的干预效果和参与者的观点提供了依据。本研究中西医学专家的跨学科合作，确保了研究设计的稳健性、参与者护理的加强、数据的严格分析以及结果的有意义解读。这项创新性研究为肿瘤学领域做出了贡献，并可能为未来基于证据的身心干预措施提供指导，以改善癌症患者的生存状况。
本研究已在澳大利亚新西兰临床试验注册中心（ACTRN12622000688785p）注册，并获得了马来亚大学医学中心医学研究伦理委员会（MREC ID NO：2022323-11092）和西悉尼大学人类研究伦理委员会（RH15124）的批准。
