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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
20
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Michigan
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Ann Arbor、Michigan、アメリカ、48105
- Cancer center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Practice log
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Side-effects/adverse events log
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年12月22日
一次修了 (実際)
2018年7月31日
研究の完了 (実際)
2018年7月31日
試験登録日
最初に提出
2017年9月27日
QC基準を満たした最初の提出物
2017年9月27日
最初の投稿 (実際)
2017年10月3日
学習記録の更新
投稿された最後の更新 (実際)
2018年8月10日
QC基準を満たした最後の更新が送信されました
2018年8月8日
最終確認日
2018年8月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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