A Feasibility Trial Comparing the Effectiveness of Virtual YOCAS©® Yoga to Standard Care for Treating Insomnia in Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Mean change in insomnia as measured by the Insomnia Severity Index (ISI) total score comparing cancer survivors in YOCAS vs. Standard Care
研究概览
简要总结
This feasibility phase II randomized controlled trial examines the preliminary efficacy of our standardized four-week YOCAS©® (Yoga for Cancer Survivors) intervention that is delivered virtually on insomnia and sleep quality in cancer survivors.
Insomnia can be described as excessive daytime napping, difficulty falling asleep, difficulty staying asleep, or waking up earlier than desired. The vast majority of patients with cancer experience some form of sleep impairment post-treatment. Yoga is safe, feasible, and effective for improving insomnia and sleep quality in cancer survivors. However, most of the yoga intervention was delivered in person. With the challenges and the social distancing regulation regarding the COVID-19 pandemic, adapting to virtual behavioral intervention is critically important and needed. Whether the yoga intervention delivered virtually to survivors provides a similar benefit of improving insomnia and sleep quality is unknown.
详细描述
PRIMARY OBJECTIVE:
To compare the effects of virtual YOCAS©® intervention to standard care on changes in insomnia measured via the Insomnia Severity Index among cancer survivors
SECONDARY OBJECTIVE:
To compare the effects of virtual YOCAS©® intervention to standard care on changes in sleep quality measured via the Pittsburgh Sleep Quality Index among cancer survivors
OUTLINE: Cancer survivors are randomized to 1 of 2 arms.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer Survivors must:
- •have a confirmed diagnosis of cancer
- •have received surgery, chemotherapy, and/or radiation therapy
- •have completed all surgery, chemotherapy, and/or radiation therapy within the last 2 months to 10 years
- •score ≥4 on a 0-10 sleep screening scale
- •be at least 18 years of age
- •be able to read and understand English
- •be able to provide informed consent
- •have access to the internet and a smartphone, tablet, and/or computer
- •have the ability to attend 8 virtual yoga sessions
排除标准
- •Cancer Survivor must not:
- •have contraindications to yoga participation
- •have practiced yoga within the 3 months prior to enrolling in the study
- •be planning to start yoga on their own during the time they are enrolled in the study
- •have a confirmed diagnosis of sleep apnea or restless leg syndrome
- •be receiving any form of treatment for cancer with the exception of hormonal or biologic therapy
- •have distant metastases
研究组 & 干预措施
Standard Care
Cancer survivors receive their standard care
干预措施: Standard Care (Other)
YOCAS
Cancer survivors receive 8 virtual yoga sessions (75 minutes/session, 2 times a week for 4 weeks) delivered via an electronic platform (e.g., Zoom)
干预措施: YOCAS©® yoga (Behavioral)
结局指标
主要结局
Mean change in insomnia as measured by the Insomnia Severity Index (ISI) total score comparing cancer survivors in YOCAS vs. Standard Care
时间窗: baseline to week 5
The Insomnia Severity Index is a validated measure of insomnia. A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change among cancer survivors in YOCAS vs. Standard Care
次要结局
- Mean Change in sleep quality as measured by the Pittsburgh Sleep Quality Inventory (PSQI) total Score comparing cancer survivors in YOCAS vs. Standard Care(baseline to week 5)
研究者
Karen Mustian
Professor
University of Rochester