Yoga for Persistent Sleep Disturbance in Cancer Survivors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Gary Morrow
- 入组人数
- 410
- 试验地点
- 22
- 主要终点
- Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI)
研究概览
简要总结
RATIONALE: Yoga may help improve sleep, fatigue, and quality of life in cancer survivors.
PURPOSE: This phase II trial is studying how well yoga works in treating sleep disturbance in cancer survivors.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of Hatha yoga in improving sleep quality in cancer survivors experiencing persistent sleep disturbance.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to gender and sleep disturbance rating reported on the eligibility assessment questionnaire (≤ 5 vs > 5). Patients are randomized to 1 of 2 arms.
- Arm I: Patients receive standard care for 6 weeks. Patients may switch to the yoga intervention immediately after study completion.
- Arm II:Patients receive standard care for 2 weeks, followed by two 75-minute sessions of Hatha yoga per week for 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of any type of cancer
- •More than 1 primary cancer allowed
- •Has undergone and completed all forms of standard treatment (surgery, chemotherapy, radiation therapy) within the past 2 to 24 months
- •Patients can be on hormones such as Tamoxifen, or monoclonal antibodies like Herceptin
- •Persistent sleep disturbance, as indicated by a response of ≥ 3 when asked to rate their sleep on an 11-point scale (0 is equivalent to no sleep disturbance and 10 is the worst possible sleep disturbance)
- •Able to read English
- •21 years of age or older
排除标准
- •No prior or concurrent regular (≥ 1 day/week) participation in yoga classes or maintain regular personal practice of any form of yoga within the past 3 months
- •No diagnosis of sleep apnea
- •No concurrent cancer therapy with the exception of hormonal therapy (e.g., tamoxifen citrate) or monoclonal antibodies (e.g., trastuzumab [Herceptin®])
- •No metastatic cancer
结局指标
主要结局
Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI)
时间窗: 2-24 months after surgery, chemotherapy, and/or radiation therapy
Pittsburgh Sleep Quality Index: Measures sleep disturbance and usual sleep habits during the prior month only using seven clinically derived domains of sleep difficulties: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Global PSQI is a summary of the seven domains. Each Domain is scored from 0 to 3, therefore PSQI has a range of 0 (better) to 21 (worse). Interpretation of the PSQI is that a score less than 5 is associated with good sleep quality and a score of 5 or greater is associated with poor sleep quality. PSQI was calculated at both pre- and post-intervention for both arms. Pre-intervention PSQI was recorded during the week immediately before commencing the 4-week intervention. Post-intervention PSQI was recorded during the week immediately following the intervention. Mean post-pre change was calculated for both arms.
次要结局
未报告次要终点
研究者
Gary Morrow
Director, URCC NCORP Research Base
University of Rochester NCORP Research Base