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临床试验/NCT02442635
NCT02442635已完成不适用

Developing a Yoga Intervention During Cancer Chemotherapy

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
73
试验地点
2
主要终点
Sleep Disturbance as measured by the General Sleep Disturbance Scale

研究概览

简要总结

This proposal aims to expand non-pharmacologic options for the control of symptoms during chemotherapy using yoga practices. It is particularly focused on sleep disturbance with a secondary focus on fatigue.

详细描述

Sleep disturbance is among the most common symptoms experienced by cancer patients, occurs in up to 80% of patients during chemotherapy, and results in serious impairments in quality of life. Although pharmacologic therapies improve sleep disturbance, they have numerous side effects, problems with tolerance and dependence, and are not well studied in oncology patients. While non-pharmacologic therapies may decrease sleep disturbance, the current level of evidence on their efficacy is insufficient. Fatigue occurs in up to 95% of those receiving chemotherapy, and results in major impairments in functioning and quality of life. Despite its significance, few effective treatments currently exist for fatigue. Prior studies suggest that yoga may be helpful for sleep disturbance and fatigue, but these studies have limitations. An important challenge in yoga research is that it is typically a multi-modality practice that can include physical postures, breathing practices, and/or meditation components. Prior studies have not adequately addressed the effects of individual components. Therefore, key questions remain unanswered about the most effective elements of yoga; how to best combine them for particular problems such as chemotherapy symptoms; and optimal dosing. The current study will address these gaps in the literature and perform key developmental steps to prepare for a large randomized, controlled trial (RCT). It builds on preliminary work in which yoga breathing practices during chemotherapy were found to improve sleep disturbance, showed trends toward improvements in fatigue, and were feasible to implement in patients undergoing chemotherapy. Using a mixed-methods approach to evaluate each intervention component, the investigators will pursue three closely interlinked steps in cancer patients receiving chemotherapy. In Aim 1 (n=10), the investigators will manualize an individualized approach to the yoga breathing intervention and iteratively refine it to insure feasibility and acceptability. In Aim 2 (n=20), the investigators will manualize a yoga posture intervention, evaluating both restorative/static poses and flowing poses, and perform iterative refinement to test feasibility and acceptability. In Aim 3 (n=70), the investigators will assess the final multi-modality yoga intervention to select final intervention elements and delivery methods for testing in a planned future RCT. This proposal will help to improve the treatment of debilitating cancer associated symptoms and advance approaches to developing therapeutic yoga intervention trials.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 and older
  • Have a Karnofsky Performance Status Score of 60 or above
  • Diagnosed with any cancer except acute leukemia
  • Self-reported poor quality of sleep
  • Receiving Chemotherapy
  • Able to read, write, and understand English
  • Ability to give informed consent

排除标准

  • Diagnosed with brain metastasis
  • Diagnosed with severe Chronic Obstructive Pulmonary Disease (COPD) or emphysema
  • Have New York Heart Association class II or greater congestive heart failure
  • Requiring chronic home oxygen therapy
  • Diagnosed with a sleep disorder (e.g., sleep apnea or narcolepsy)
  • Have received more than 3 prior chemotherapy regimens
  • Receiving radiation therapy
  • Has a less than 6 month life expectancy
  • Regular yoga practice within the last 2 months

结局指标

主要结局

Sleep Disturbance as measured by the General Sleep Disturbance Scale

时间窗: 6 weeks

次要结局

  • Fatigue as measured by the Lee Fatigue Scale(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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