Yoga for Fatigue in the Survivors of Bone Marrow Transplantation
2018年8月8日 更新者：Mohamad Baydoun、University of Michigan
Yoga for Persistent Fatigue in the Survivors of Bone Marrow Transplantation: A Feasibility Study
Cancer-related fatigue (CRF) after hematopoietic cell transplantation (HCT) is a persistent problem that limits activities and causes distress.
Considering the high prevalence of CRF among HCT survivors and the limitations of currently existing treatments, there is a pressing need for establishing safe and effective options for reducing CRF after HCT.
Based on evidence supporting the use of yoga for CRF in non-HCT populations, yoga is one option worthy of evaluation for ameliorating CRF in HCT patients.
Yoga is easy to implement, may be appealing to HCT patients, and can be self-administered, which would encourage long-term use and potentially lead to a better control of persistent CRF in HCT survivors.
The primary aim of the proposed study is to assess the feasibility of a yoga intervention for HCT survivors with CRF.
Outcomes from this feasibility study will provide the information needed to design a larger, adequately powered randomized controlled trial to evaluate yoga for CRF in HCT survivors.
This study will employ a mixed-methods, single-arm, pretest-posttest design with focus groups.
Twenty HCT survivors who report at least moderate fatigue will be recruited from the HCT clinic, Michigan Medicine.
Participants will be enrolled in a six-week Restorative yoga program.
The program will consist of a weekly, 60-minute yoga group class led by a certified yoga instructor along with twice-weekly home practice using yoga DVD.
研究概览
详细说明
OBJECTIVES
Primary Objective: To assess the feasibility of an organized yoga intervention for HCT survivors with CRF.
Hypothesis: A trial of yoga in the HCT survivor population will be deemed feasible if at least 75% of study subjects demonstrated protocol adherence rate of at least 80%.
Secondary Objectives:
- Explore participants' perceptions regarding yoga and physical activity
Hypothesis: HCT survivors will be positive about yoga and will express satisfaction with the yoga program, as will be shown during focus groups that will be held at the end of the yoga program.
- Evaluate the association between yoga practice and self-efficacy and self-regulation
Hypothesis: Adherence to yoga will be associated with higher self-efficacy and selfregulation scores.
- Evaluate the changes in CRF scores from baseline to the end of the yoga program.
Hypothesis: CRF scores at the end of the yoga program will be lower than CRF scores at baseline.
- Evaluate whether changes in CRF are associated with changes in depression, sleep disturbances, physical activity, and pain.
Hypothesis 5: Improvement in CRF will be associated with increased physical activity and decreased depression, sleep disturbances, and pain.
- Evaluate the safety of yoga practice in HCT survivors.
Hypothesis: Yoga will be considered as a safe intervention for CRF in HCT survivors as demonstrated by the absence of adverse events or serious adverse events related to or associated with yoga practice.
研究类型
介入性
注册 (实际的)
20
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
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Michigan
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Ann Arbor、Michigan、美国、48105
- Cancer center
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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:
- Adult HCT survivors as defined by being at least 100 days post autologous or allogeneic transplantation for a malignant disease. There is no restriction to enrollment by donor type, donor cell source, presence or absence of graft versus host disease.
- Age ≥ 18 years at the time of transplant.
- A history of persistent CRF as defined by a perception of general CRF for at least one month before enrollment.
- A history of at least moderate CRF as defined by a CRF score of 4 or more on a 10-point Visual Analog Scale.
- Participants who are deemed qualified for yoga movements according to the Yoga Qualifying Movements Screening Checklist (a checklist developed by researchers at the University of California, Los Angeles to promote yoga safety through assessing the eligibility of each patient)
Exclusion Criteria:
- A self-reported current practice of yoga or any other mind-body therapy, including but not limited to meditation or hypnosis therapy in the past 30 days prior to study enrollment.
- Subjects currently on supplemental oxygen support.
- Subjects currently receiving hemodialysis.
- Subjects currently admitted to an inpatient unit at Michigan Medicine.
- Subjects with an uncontrolled, active infection. Subjects with viremia (Cytomegalovirus or other) may be enrolled, provided they are on active therapy and at the discretion of the treating physician.
- Subjects who have relapsed after their autologous or allogeneic transplant.
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：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Yoga arm
A six-week restorative yoga intervention consisting of a weekly, 60-minute yoga group class led by a certified yoga instructor along with twice-weekly home practice using yoga DVD.
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This is a single arm study and all participants will be assigned to a six-week restorative yoga intervention.
Restorative yoga sessions will consist of gentle physical poses (asanas), breathing control (pranayama), and relaxation (savasana).
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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 |
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Practice log
大体时间：Weekly during the six-week intervention period
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Yoga practice at home will be documented on a log sheet to be filled out by participants at the end of each practice week.
We will check class attendance during the weekly telephone call with the study participants.
We will use a log sheet to document in-class yoga practice and location of the yoga performance.
At the end of the program, the number of yoga practice hours per participant will be tabulated.
This number will be used to evaluate participants' adherence to yoga practice.
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Weekly during the six-week intervention period
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Side-effects/adverse events log
大体时间：Weekly during the six-week intervention period
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All subjects will be asked to complete a Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) weekly.
The PRO-CTCAE questionnaire in this study includes a total of six items (numbness and tingling, dizziness, blurry vision, muscle pain, joint pain, others).
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Weekly during the six-week intervention period
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Multidimensional Fatigue Symptom Inventory
大体时间：At baseline (before treatment) and within 10 days of the last in-class yoga session
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The Multidimensional Fatigue Symptom Inventory-Short Form (MFSISF) will be used to measure fatigue in the past seven days.
The MFSISF includes a total of 30 items that produce five subscales: general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor.
All items have a possible score of 0 to 4, 0 representing "not at all" and 4 being "extremely".
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At baseline (before treatment) and within 10 days of the last in-class yoga session
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PROMIS-SF-Fatigue
大体时间：At baseline (before treatment) and within 10 days of the last in-class yoga session
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The PROMIS-SF-Fatigue will be used to measure fatigue in the past seven days.
The PROMIS-SF-fatigue is a unidimensional scale that measures general fatigue.
It contains eight items with a possible score of 1 to 5 for each item.
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At baseline (before treatment) and within 10 days of the last in-class yoga session
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Brief Pain Inventory - Short Form
大体时间：At baseline (before treatment) and within 10 days of the last in-class yoga session
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The Brief Pain Inventory - Short Form (BPISF) will be used to measure pain in the past 24 hours.
The BPISF is a 9-item questionnaire used to evaluate the severity of a participants' pain and the impact of pain on the patient's daily functioning.
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At baseline (before treatment) and within 10 days of the last in-class yoga session
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PROMIS-SF-depression
大体时间：At baseline (before treatment) and within 10 days of the last in-class yoga session
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The PROMIS-SF-depression will be used to measure depression in the past seven days.
The PROMIS-SF-depression contains eight items with a possible score of 1 to 5 for each item (1: never, 5: always).
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At baseline (before treatment) and within 10 days of the last in-class yoga session
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PROMIS-SF-sleep disturbance
大体时间：At baseline (before treatment) and within 10 days of the last in-class yoga session
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The PROMIS-SF-sleep disturbance will be used to measure sleep disturbance in the past seven days.
The PROMIS-SF-sleep disturbance contains eight items with a possible score of 1 to 5 for each item.
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At baseline (before treatment) and within 10 days of the last in-class yoga session
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Index of Self-Regulation Scale
大体时间：At baseline (before treatment) and within 10 days of the last in-class yoga session
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The Index of Self-Regulation Scale (ISR) is designed to measure individuals' level of self-regulation for health behaviors.
The ISR contains nine items that produces three subscales: reconditioning, stimulus control, and behavioral monitoring.
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At baseline (before treatment) and within 10 days of the last in-class yoga session
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Self-Efficacy for Managing Chronic Disease Scale
大体时间：At baseline (before treatment) and within 10 days of the last in-class yoga session
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Self-efficacy will be measured using the Self-Efficacy for Managing Chronic Disease Scale (SEMCD).
The SEMCD contains six items.
Each item has a possible score of 1 to 10 (1: not at all confident, 10: totally confident).
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At baseline (before treatment) and within 10 days of the last in-class yoga session
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PROMIS-SF- physical function
大体时间：At baseline (before treatment) and within 10 days of the last in-class yoga session
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The PROMIS-SF- physical function contains 12 items with a possible score of 1 to 5 for each item (1: unable to do, 5: without any difficulty).
All items are reversely coded.
The total score can range from 12 to 60 with higher scores indicating better physical function.
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At baseline (before treatment) and within 10 days of the last in-class yoga session
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electronic pedometer
大体时间：At baseline (before treatment) and within 10 days of the last in-class yoga session
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The electronic pedometer is an objective measure of physical activity.
It is a simple, unobtrusive device that can be placed on the belt or waistband to count the number of steps taken.
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At baseline (before treatment) and within 10 days of the last in-class yoga session
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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。
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)
2017年12月22日
初级完成 (实际的)
2018年7月31日
研究完成 (实际的)
2018年7月31日
研究注册日期
首次提交
2017年9月27日
首先提交符合 QC 标准的
2017年9月27日
首次发布 (实际的)
2017年10月3日
研究记录更新
最后更新发布 (实际的)
2018年8月10日
上次提交的符合 QC 标准的更新
2018年8月8日
最后验证
2018年8月1日
更多信息
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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