放射線療法を受けている高悪性度神経膠腫患者とそのパートナーの生活の質を改善するためのカップルベースのヨガプログラム
神経膠腫患者とそのパートナーのためのカップルベースのヨガプログラム
This randomized clinical trial studies couples-based yoga program in improving quality of life in patients with high-grade glioma undergoing radiation therapy and their partners. A couple-based Hatha yoga program may improve fatigue, distress, sleep quality, and overall quality of life in patients with glioma and their partners.
調査の概要
状態
詳細な説明
PRIMARY OBJECTIVES:
I. Examine the feasibility of a couple-based and a caregiver yoga program in glioma patients undergoing radiotherapy (RT) and their partners.
SECONDARY OBJECTIVES:
I. Establish the initial efficacy of the yoga program in patients and their partners regarding quality of life (QOL) outcomes (i.e., fatigue, sleep disturbance, depressive symptoms, and overall QOL and health care utilization).
EXPLORATORY OBJECTIVES:
I. Explore potential moderation (e.g., baseline psychological distress, patients' tumor grade, performance status and class attendance) of the intervention effects.
OUTLINE: The first five couples are assigned to arm I. All subsequent couples are randomized to 1 of 2 arms.
ARM I: Patients and their partners attend up to 15, 45-60 minute sessions of Hatha yoga over the course of radiation therapy 5 times a week for 5-6 weeks. The program comprises four main components: joint loosening with breath synchronization; postures with deep relaxation techniques; breath energization with sound resonance; and meditation. At the fifth session, patients and their partners receive a digital video disc (DVD) and are encouraged to practice on their own (individually and/or together) on the days when they do not meet with the instructor.
ARM II: Patients receive standard of care provided by the health care team and complete questionnaires before and after radiation therapy.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Texas
-
Houston、Texas、アメリカ、77030
- M D Anderson Cancer Center
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Able to read and speak English
- Able to provide informed consent
- PATIENTS ONLY: Diagnosed with a primary glioma and going to receive at least 4 weeks of radiotherapy with at least 20 fractions
- PATIENTS ONLY: Karnofsky performance status (KPS) of 80 or above
- PATIENTS ONLY: Having an informal caregiver (spouse, romantic partner, adult child, sibling, or friend) who is willing to participate; for phase 1 only, if patients do not have one consistent primary caregiver for the duration of the study, they may be accompanied to the yoga sessions by an alternate caregiver who meets eligibility criteria
Exclusion Criteria:
- PATIENTS ONLY: for phase 1 only, regularly (self-defined) participated in a yoga practice in the year prior to diagnosis
- PATIENTS ONLY: for phase 1 only, physician-rated life expectancy of less than 6 months
- PATIENTS ONLY: for phase 1 and 2, cognitive deficits that would impede the completion of self-report instruments as deemed by the clinical team
研究計画
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：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
|
実験的：Arm I (couple-based Hatha yoga program)
Patients and their partners attend up to 15, 45-60 minute sessions of Hatha yoga over the course of radiation therapy 5 times a week for 5-6 weeks. The program comprises four main components: joint loosening with breath synchronization; postures with deep relaxation techniques; breath energization with sound resonance; and meditation. At the fifth session, patients and their partners receive a DVD and are encouraged to practice on their own (individually and/or together) on the days when they do not meet with the instructor. |
Ancillary studies
他の名前：
Ancillary studies Receive DVD for home practice Complete couple-based Hatha yoga program
他の名前：
|
|
アクティブコンパレータ：Arm II (waitlist control)
Patients receive standard of care provided by the health care team and complete questionnaires before and after radiation therapy. |
Ancillary studies
他の名前：
Ancillary studies Undergo standard of care
他の名前：
|
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 |
|---|---|---|
|
全体的な発生によって決定される、カップルベースのヨガプログラムの実現可能性
時間枠：最大6週間
|
最大6週間
|
|
|
有害事象および重大な有害事象の発生率によって決定される、カップルベースのヨガプログラムの実現可能性
時間枠：最大6週間
|
最大6週間
|
|
|
Feasibility of a couple-based yoga program, determined by attrition using the Mental Component Summary of Short Form-36
時間枠：Up to 6 weeks
|
The questionnaires ask about health, any symptoms, mood, level of fatigue, sleeping habits, relationship, and quality of life. Scale answers range from: All of the time, Most of the time, Some of the time, A little of the time, None of the time. |
Up to 6 weeks
|
|
Feasibility of a couple-based yoga program determined by adherence
時間枠：Up to 6 weeks
|
Trial determined feasible if 1) ≥ 50% of eligible couples consent (i.e., approach 80 couples to obtain 40 consents in phase 1 and approach 150 dyads to achieve 75 that consent in phase 2); 2) ≥ 70% of enrolled couples complete all assessments; 3) on average ≥ 50% of all practice sessions are attended; 4) no attributable AE or SAE occur |
Up to 6 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Preliminary evidence of intervention efficacy, measured by answers on change in quality of life (QOL): SF-36 questionnaire
時間枠：Up to 6 weeks
|
Question answers range : All of the time, Most of the time, Some of the time, A little of the time, None of the time |
Up to 6 weeks
|
協力者と研究者
捜査官
- 主任研究者：Kathrin Milbury, MA,PHD、M.D. Anderson Cancer Center
出版物と役立つリンク
一般刊行物
- Snyder S, Silva RF, Whisenant MS, Milbury K. Videoconferenced Yoga Interventions for Cancer Patients and their Caregivers during the COVID-19 Pandemic: A Report from a Clinician's Perspective. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211019111. doi: 10.1177/15347354211019111.
- Milbury K, Li J, Weathers SP, Mallaiah S, Armstrong T, Li Y, Bruera E, Cohen L. Pilot randomized, controlled trial of a dyadic yoga program for glioma patients undergoing radiotherapy and their family caregivers. Neurooncol Pract. 2019 Jul;6(4):311-320. doi: 10.1093/nop/npy052. Epub 2018 Dec 20.
- Milbury K, Li J, Weathers SP, Shih T, Malliaha S, Li Y, Cohen L. A research protocol for a pilot, randomized controlled trial designed to examine the feasibility of a dyadic versus individual yoga program for family caregivers of glioma patients undergoing radiotherapy. Pilot Feasibility Stud. 2019 Jul 25;5:95. doi: 10.1186/s40814-019-0479-5. eCollection 2019.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (推定)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2015-0013
- 2015-0013 (その他の識別子：M D Anderson Cancer Center)
- NCI-2015-01124 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。