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Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy in Reducing Insomnia in Cancer Survivors (YOCAS-II)

2021年2月27日 更新者：Karen Mustian、University of Rochester NCORP Research Base

A Randomized Clinical Trial Comparing the Effectiveness of Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy for Treating Insomnia in Cancer Survivors

This randomized phase III trial compares yoga, survivorship health education program, and cognitive behavioral therapy in reducing sleep disturbance (insomnia) in cancer survivors. Insomnia can be described as excessive daytime napping, difficulty falling asleep, difficulty staying asleep, or waking up earlier than desired. Insomnia can increase fatigue, impair physical function, impair immune function, cause circadian rhythms (known as the biological clock) to be disrupted and decrease quality of life. Yoga may improve circadian rhythms, physical and immune function, and improve insomnia and sleep quality in cancer survivors. It is not yet known whether yoga is more effective at treating insomnia than a health education program or cognitive behavioral therapy program.

研究概览

地位

完全的

条件

干预/治疗

详细说明

PRIMARY OBJECTIVES:

I. To determine if Yoga for Cancer Survivors (YOCAS) is effective for improving patient-reported insomnia (Insomnia Severity Index) compared to Cognitive Behavioral Therapy for Insomnia (CBT-I) and a health education control immediately post intervention.

SECONDARY OBJECTIVES:

I. To examine if YOCAS is effective for improving objective symptoms of insomnia (sleep latency, sleep efficiency, wake after sleep onset, sleep duration, and daytime napping via actigraphy) and global sleep quality impairment (Pittsburgh Sleep Quality Index) compared to CBT-I and a health education control.

II. To examine if YOCAS and CBT-I are effective for maintaining improvements in insomnia (Insomnia Severity Index) 3 and 6 months post intervention compared to a health education control.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.

ARM II: Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.

ARM III: Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, "Cancer Survivorship Next Steps for Patients and Their Families."

After completion of intervention, patients are followed up at 3 and 6 months.

研究类型

介入性

注册 (实际的)

746

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Hawaii
      • Honolulu、Hawaii、美国、96813
        • Hawaii MU NCORP
    • Illinois
      • Decatur、Illinois、美国、62526
        • Heartland NCORP
    • Kansas
      • Wichita、Kansas、美国、67214
        • Wichita NCORP
    • Louisiana
      • New Orleans、Louisiana、美国、70112
        • Gulf South MU-NCORP
    • Michigan
      • Ann Arbor、Michigan、美国、48106
        • Michigan Cancer Research Consortium NCORP
      • Grand Rapids、Michigan、美国、49503
        • Cancer Research Consortium of West Michigan
    • Minnesota
      • Minneapolis、Minnesota、美国、55426
        • Metro-Minnesota NCORP
    • Nevada
      • Las Vegas、Nevada、美国、89106
        • Nevada Cancer Research Foundation NCORP
    • New York
      • Rochester、New York、美国、14642
        • University of Rochester NCORP Research Base
    • North Carolina
      • Winston-Salem、North Carolina、美国、27104
        • Southeast Clinical Oncology Research Consortium
    • Ohio
      • Columbus、Ohio、美国、43215
        • Columbus NCORP
      • Dayton、Ohio、美国、45420
        • Dayton Clinical Oncology Program
    • Oregon
      • Portland、Oregon、美国、97213
        • Pacific Cancer Research Consortium Ncorp
    • South Carolina
      • Greenville、South Carolina、美国、29605
        • Greenville Health System NCORP
    • Wisconsin
      • Marshfield、Wisconsin、美国、54449
        • Wisconsin NCORP
      • Milwaukee、Wisconsin、美国、53226
        • Aurora NCORP

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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 2-60 months
  • Meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-V criteria for insomnia and score >= 10 on the Insomnia Severity Index
  • Be able to read and understand English
  • Be able to provide written informed consent

Exclusion Criteria:

  • Have contraindications to functional testing or yoga participation according to the treating physician
  • Have practiced yoga >= 1 day a week 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Arm I (behavioral intervention-yoga)
Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.
其他：实验室生物标志物分析
相关研究
其他：生活质量评估
辅助研究
其他名称：
  • 生活质量评估
行为的：Behavioral Intervention
Undergo yoga intervention
其他名称：
  • 行为调节疗法
  • 行为矫正
  • 行为或生活方式的改变
  • 行为疗法
  • 行为干预
  • 行为治疗
设备：Monitoring Device
Correlative studies
其他名称：
  • 监视器
实验性的：Arm II (cognitive intervention-CBT-I)
Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.
其他：实验室生物标志物分析
相关研究
其他：生活质量评估
辅助研究
其他名称：
  • 生活质量评估
设备：Monitoring Device
Correlative studies
其他名称：
  • 监视器
其他：Cognitive Intervention
Undergo CBT-I intervention
有源比较器：Arm III (educational intervention)
Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, "Cancer Survivorship Next Steps for Patients and Their Families."
其他：实验室生物标志物分析
相关研究
其他：生活质量评估
辅助研究
其他名称：
  • 生活质量评估
其他：教育干预
接受健康教育
其他名称：
  • 干预教育
  • 教育干预
  • 通过教育进行干预
  • 干预，教育
设备：Monitoring Device
Correlative studies
其他名称：
  • 监视器

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Mean Change in the ISI Comparing YOCAS vs. CBT-I
大体时间：Baseline up to post intervention (approximately 4 to 8 weeks)
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. Means and 95% confidence intervals for YOCAS and CBT-I will be calculated and plotted and examined in comparison with the a priori specified non-inferiority margin of 1.15.
Baseline up to post intervention (approximately 4 to 8 weeks)
Mean Change in the ISI Comparing YOCAS vs. Health Education
大体时间：Baseline up to post intervention (approximately 4 to 8 weeks)
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 between YOCAS and health education.
Baseline up to post intervention (approximately 4 to 8 weeks)

次要结果测量

结果测量
措施说明
大体时间
Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. Health Education
大体时间：Baseline up to post intervention (approximately 4 to 8 weeks)
The PSQI measures sleep quality with a total score ranging from 0-21 with higher scores indicating worse sleep quality. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.
Baseline up to post intervention (approximately 4 to 8 weeks)
Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. CBT-I.
大体时间：Baseline up to post intervention (approximately 4 to 8 weeks)
The PSQI measures sleep quality with a total score ranging from 0-21 with higher scores indicating worse sleep quality. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I.
Baseline up to post intervention (approximately 4 to 8 weeks)
Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. Health Education
大体时间：Baseline up to post intervention (approximately 4 to 8 weeks)
Actigraphy will measure the number of minutes of actual sleep. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.
Baseline up to post intervention (approximately 4 to 8 weeks)
Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. CBT-I
大体时间：Baseline up to post intervention (approximately 4 to 8 weeks)
Actigraphy will measure the number of minutes of actual sleep. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I.
Baseline up to post intervention (approximately 4 to 8 weeks)
Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. Health Education
大体时间：Baseline up to post intervention (approximately 4 to 8 weeks)
Actigraphy will measure total minutes of wake time after sleep onset. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education. The transformation of the log base 10 of the original measurement was used for the analysis.
Baseline up to post intervention (approximately 4 to 8 weeks)
Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. CBT-I
大体时间：Baseline up to post intervention (approximately 4 to 8 weeks)
Actigraphy will measure total minutes of wake time after sleep onset. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I. The transformation of log base 10 of the original measurement was used for the analysis.
Baseline up to post intervention (approximately 4 to 8 weeks)
Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. Health Education
大体时间：Baseline up to post intervention (approximately 4 to 8 weeks)
Actigraphy will measure the percent of time actually slept compared to intended time sleeping. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.
Baseline up to post intervention (approximately 4 to 8 weeks)
Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. CBT-I
大体时间：Baseline up to post intervention (approximately 4 to 8 weeks)
Actigraphy will measure the percent of time actually slept compared to intended time sleeping. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I.
Baseline up to post intervention (approximately 4 to 8 weeks)
Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. Health Education
大体时间：Baseline up to post intervention (approximately 4 to 8 weeks)
Actigraphy will measure the minutes it takes for the participant to fall asleep. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education. The transformation of log base 10 of the (measurement + 1) was used in the analysis.
Baseline up to post intervention (approximately 4 to 8 weeks)
Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. CBT-I
大体时间：Baseline up to post intervention (approximately 4 to 8 weeks)
Actigraphy will measure the minutes it takes for the participant to fall asleep. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I. The transformation of the log base 10 of the (measure + 1) was used in the analysis.
Baseline up to post intervention (approximately 4 to 8 weeks)
Mean Change in the ISI Comparing YOCAS and Health Education (3 Month)
大体时间：Baseline to 3 months
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 between YOCAS and health education.
Baseline to 3 months
Mean Change in the ISI Comparing YOCAS and CBT-I (3 Month)
大体时间：Baseline to 3 months
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 between YOCAS and CBT-I.
Baseline to 3 months
Mean Change in the ISI Comparing YOCAS and Health Education (6 Month)
大体时间：Baseline to 6 months
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 between YOCAS and health education.
Baseline to 6 months
Mean Change in the ISI Comparing YOCAS and CBT-I (6 Month)
大体时间：Baseline to 6 months
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 between YOCAS and CBT-I.
Baseline to 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Rochester NCORP Research Base

合作者

National Cancer Institute (NCI)

调查人员

  • 首席研究员：Karen Mustian、University of Rochester NCORP Research Base

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年5月6日

初级完成 (实际的)

2020年2月4日

研究完成 (实际的)

2020年2月4日

研究注册日期

首次提交

2015年11月20日

首先提交符合 QC 标准的

2015年11月23日

首次发布 (估计)

2015年11月24日

研究记录更新

最后更新发布 (实际的)

2021年3月23日

上次提交的符合 QC 标准的更新

2021年2月27日

最后验证

2021年2月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • URCC14040 (其他标识符：University of Rochester NCORP Research Base)
  • UG1CA189961 (美国 NIH 拨款/合同)
  • NCI-2015-01144 (注册表标识符：CTRP (Clinical Trial Reporting Program))
  • RSRB052271 (其他标识符：University of Rochester)
  • URCC-14040 (其他标识符：CTEP)
  • R01CA181064 (美国 NIH 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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条件

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地点

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