The Effect of Tai-chi/Qi-gong on Quality of Life (QOL), Sleep, and Fatigue in Patients With Gynecological Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in the Multidimensional Quality of Life Scale cancer MQOLS-CA
研究概览
简要总结
Oncologic patients often report increased fatigue during and after chemotherapy. Evidence suggests Tai-chi/Qi-gong may improve quality of life (QOL) in oncologic patients treated with chemotherapy. Previous studies, mostly performed in a population of breast cancer patients, have demonstrated the benefits of Tai-chi/Qi-gong practice in improving quality of life (1), reducing bone resorption (2), preventing the decrease of blood counts (WBC and Hb) (3), and reducing inflammation (4).
The aim of this pilot study is to evaluate the effect of Tai-chi/Qi-gong on QOL, sleep, and fatigue in patients with gynecological malignancies, particularly in patients with ovarian cancer.
详细描述
Tai-chi/Qi-gong is a complementary medicine technique that synergizes the mind-body connection. The technique employs a series of positions and movements that are performed in a slow, flowing manner to help a person concentrate on breathing and motion.
The effect of Tai-chi/Qi-gong on fatigue, quality of life, and quality of sleep will be assessed in gynecological cancer patients. This trial will recruit 60 patients with gynecological malignancies, who receive first or second line chemotherapy. The patients will be allocated according to their preference to either the study or the control group. The Tai-chi/Qi-gong classes will take place once a week, for 10 consecutive weeks, at the facilities of the gyneco-oncology department. All patients will fill out the questionnaires at the beginning of the study, after 5 weeks, and upon the completion of the study (10 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with gynecological malignancies undergoing primary or secondary chemotherapy
排除标准
- •Motor disability;
- •Less than 1 month since the last abdominal surgery;
结局指标
主要结局
Change in the Multidimensional Quality of Life Scale cancer MQOLS-CA
时间窗: Week 0, Week 5, Week 10
The Multidimensional Quality of Life Scale cancer MQOLS-CA was written by Padilla (5) and translated into Hebrew by Dorit Pud (6).
次要结局
- Change in the Visual Analog Scale for Pain(Week 0, Week 5, Week 10)
- Change in the Lee Fatigue Scale (LFS)(Week 0, Week 5, Week 10)
研究者
Dorit Gamus
Director, Complementary Medicine Service
Sheba Medical Center