Centre for Health, Activity and Rehabilitation Research, School of Physiotherapy, University of Otago, Dunedin 9054, New Zealand.
Department of Surgical Sciences, Southern District Health Board, Dunedin 9016, New Zealand.
J Integr Med. 2018 Mar;16(2):99-105. doi: 10.1016/j.joim.2017.12.011. Epub 2018 Jan 31.
Breast cancer patients experience various side effects during cancer therapy, often resulting in reduced quality of life and poor adherence to treatment. A limited range of proven interventions has been developed to target such side effects. While Tai Chi offers benefits for the health and well-being of breast cancer survivors, the effectiveness of Tai Chi across the treatment continuum has not been evaluated. Improved patient education and support has been suggested as a priority for breast cancer care. This pilot study assesses the feasibility of a randomized controlled trial (RCT) to evaluate the effectiveness of "an integrative Tai Chi" (ANITA) program for breast cancer patients undergoing cancer therapy.
METHODS/DESIGN: This is a single-centre, two-arm feasibility RCT. Twenty-four patients with breast cancer who have undergone surgical treatment will be recruited from the Dunedin Hospital (New Zealand) over a 12-month period (from August 2017 to July 2018). Subject to informed consent, patients will be randomized to receive standard cancer treatment alone or standard cancer treatment plus the ANITA program, consisting of peer support, health education, and Tai Chi Ruler exercise. The program runs alongside the patient's adjuvant cancer therapy, which may include chemotherapy, radiation therapy, antibody treatment, and/or antihormonal therapy. Analysis in this study will focus on process evaluation of participant recruitment, retention, treatment fidelity, acceptability of the program, and occurrence of adverse events. Clinical outcomes (i.e., fatigue, sleep quality, anxiety and depression and quality of life) will be assessed at baseline, and at 12 weeks and 24 weeks post-randomization.
Outcomes from this study will inform the feasibility and methodology for a future fully-powered RCT.
Australian New Zealand Clinical Trials Registry with the identifier ACTRN12617000975392.
乳腺癌患者在癌症治疗过程中会经历各种副作用，常常导致生活质量下降和治疗依从性差。目前已经开发出有限数量的经过验证的干预措施来针对这些副作用。虽然太极拳对乳腺癌幸存者的健康和福祉有益，但太极拳在整个治疗过程中的有效性尚未得到评估。改善患者教育和支持已被提议作为乳腺癌护理的优先事项。这项初步研究评估了一项随机对照试验 (RCT) 的可行性，以评估针对正在接受癌症治疗的乳腺癌患者的“综合太极拳” (ANITA) 计划的有效性。
方法/设计：这是一项单中心、两臂可行性 RCT。在 12 个月的时间内（2017 年 8 月至 2018 年 7 月），将从达尼丁医院（新西兰）招募 24 名接受过手术治疗的乳腺癌患者。在获得知情同意的前提下，患者将被随机分配接受标准癌症治疗或标准癌症治疗加 ANITA 计划，该计划包括同伴支持、健康教育和太极尺练习。该计划与患者的辅助癌症治疗同时进行，辅助癌症治疗可能包括化疗、放疗、抗体治疗和/或抗激素治疗。本研究的分析将重点关注参与者招募、保留、治疗一致性、方案可接受性以及不良事件发生的过程评估。临床结局（即疲劳、睡眠质量、焦虑和抑郁以及生活质量）将在基线、随机分组后 12 周和 24 周进行评估。
该研究的结果将为未来的完全-powered RCT 提供可行性和方法学信息。
澳大利亚新西兰临床试验注册中心，标识符 ACTRN12617000975392。
