Self-acupressure and Zhan Zhuang for Pain, Fatigue, and Sleep Disturbance in Breast Cancer Survivors: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Sleep disturbance
研究概览
简要总结
The proposed study will be a 3-arm, parallel-group randomized controlled trial on the effects of self-acupressure and Zhan-Zhuang for alleviating pain, fatigue, and sleep disturbance in breast cancer survivors. Subjects will include 54 breast cancer survivors who have experienced a moderate level of pain, fatigue and sleep disturbance. All eligible subjects will be randomized into one of the three groups in a 1:1:1 ratio: Zhan Zhuang group, or self-acupressure group, or wait list control group. Subjects in the Zhan-Zhuang group will receive up to 8 weeks of the intervention consisting of a training course over two weeks followed by self-practice for 6 weeks. Those in the self-acupressure group will attend an acupressure training course for two weeks and then, will be asked to practice self-acupressure for 6 weeks. The wait list control group will be provided with delayed self-acupressure or Zhan Zhuang at the end of the study. Outcome assessment will be conducted at baseline, week 8 (post-intervention) and week 12 (4 week follow-up). Primary outcomes include pain, fatigue and sleep disturbance. Secondary outcomes include psychological distress and health-related quality of life. Qualitative data will be collected from selected participants who have received the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •a female adult aged 18 and older;
- •a diagnosis of early-stage (Stage I, II, or III) breast cancer;
- •completion of surgery, and/or chemotherapy and/or radiotherapy;
- •have at least a moderate level of pain, fatigue and sleep disturbance as measured on 0-10 numerical rating scales, with a score of ≥ 3 for each symptom during the past one month;
- •willing to use WhatsApp messenger for follow-ups;
- •being able to communicate in Chinese
排除标准
- •prior use of acupuncture, acupressure, Zhan Zhuang, or other types of Zhan Zhuang within the past three months;
- •currently receiving progressive muscle relaxation, mindfulness-based stress reduction, and other body mind exercise (e.g. yoga) for the treatment of pain, fatigue, and sleep disturbance;
- •mentally incapable of participating in the study as indicated by the Hong Kong version of Montreal Cognitive Assessment score;
- •inability to perform self-care as indicated by the Karnofsky Performance Scale score<70
结局指标
主要结局
Sleep disturbance
时间窗: Baseline, after 8 weeks, after 12 weeks
Sleep disturbance will be measured by the 19-item traditional Chinese version of the Pittsburgh Sleep Quality Index. The questionnaire consists of seven domains using 19 items: overall sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, day dysfunction due to sleepiness, and use of sleeping medication. The global score is calculated by summing up the scores of seven domains, with a higher score indicating greater sleep disturbance.
Pain(severity and interference)
时间窗: Baseline, after 8 weeks, after 12 weeks
Pain will be measured by the traditional Chinese version of the Brief Pain Inventory. The questionnaire has 9 items assessing pain severity and interference with activities. It is rated using a 0-10 scale (0= no pain and no interference, 10=pain as bad as one can imagine and interferes completely).
Fatigue
时间窗: Baseline, after 8 weeks, after 12 weeks
Fatigue will be measured by the traditional Chinese version of the Brief Fatigue Inventory. The questionnaire has 9 items assessing pain severity and interference with activities. It is rated using a 0-10 scale (0= no pain and no interference, 10=pain as bad as one can imagine and interferes completely).
次要结局
- Psychological distress(Baseline, after 8 weeks, after 12 weeks)
- Health-related quality of life(Baseline, after 8 weeks, after 12 weeks)