摘要
Background： 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 evalu- ated. 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 ran- domized to receive standard cancer treatment alone or standard cancer treatment plus the ANITA pro- gram, 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. Discussion： Outcomes from this study will inform the feasibility and methodology for a future fully- powered RCT.
Background： 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 evalu- ated. 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 ran- domized to receive standard cancer treatment alone or standard cancer treatment plus the ANITA pro- gram, 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. Discussion： Outcomes from this study will inform the feasibility and methodology for a future fully- powered RCT.
基金
funded by the Breast Cancer Foundation New Zealand
support of which is gratefully acknowledged
This funding source has no role in this study other than providing funding support
LL is funded as the Breast Cancer Foundation New Zealand Belinda Scott Clinical Fellowship 2017
