癌症相关的疲劳及其相关的睡眠障碍和抑郁症状在癌症幸存者中普遍存在,尤其是在乳腺癌患者中,肺,和结直肠癌幸存者。虽然目前还没有治疗癌症相关性疲劳的黄金标准,对气功等身心锻炼的研究报告了减轻症状的希望。这项研究旨在评估国林气功对乳腺癌癌症相关性疲劳和其他症状的可行性和效果。肺癌和结直肠癌幸存者,同时探索他们对国林气功干预的看法和经验。
■这是一项开放标签的随机对照试验,有60名参与者以1:1的比例分为2个研究组。干预组将接受12周的国林气功干预,并进行4周的随访,而对照组将在等待名单下接受常规护理。主要结果将是根据招聘和保留率衡量可行性,上课出勤,坚持家庭实践,自然,以及缺失数据的数量和安全性。疲劳的次要主观结果,睡眠质量和抑郁将在第1周(基线)进行测量,第6周(干预中期),第12周(干预后),和第16周(干预后4周),而客观的24小时尿皮质醇将在第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半结构化访谈,以获得更全面的实践依从性。
■这是首次研究国林气功对乳房的可行性和效果的混合方法研究,肺,和结直肠癌幸存者全面了解国林气功的干预影响和参与者的观点。这项研究的西医和中医专业知识之间的跨学科合作确保了稳健的研究设计,加强参与者护理,严格的数据分析,对结果进行有意义的解释。这项创新研究为肿瘤学领域做出了贡献,并可能指导未来基于证据的身心干预以改善癌症生存率。
■本研究已在ANZCTR(ACTRN12622000688785p)注册,由马来亚大学医学中心医学研究伦理委员会(MRECIDNO:2022323-11092)批准,并获得西悉尼大学人类研究伦理委员会(RH15124)的认可。
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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).