방사선 치료를 받고 있는 고도 신경아교종 환자와 파트너의 삶의 질 향상을 위한 커플 기반 요가 프로그램
신경아교종 환자와 파트너를 위한 커플 기반 요가 프로그램
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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Texas
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Houston, Texas, 미국, 77030
- M D Anderson Cancer Center
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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
다른 이름들:
Ancillary studies Receive DVD for home practice Complete couple-based Hatha yoga program
다른 이름들:
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활성 비교기: 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
다른 이름들:
Ancillary studies Undergo standard of care
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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전체 발생액에 따라 결정되는 커플 기반 요가 프로그램의 타당성
기간: 최대 6주
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최대 6주
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부작용 및 심각한 부작용의 발생률에 따라 결정되는 커플 기반 요가 프로그램의 타당성
기간: 최대 6주
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최대 6주
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Feasibility of a couple-based yoga program, determined by attrition using the Mental Component Summary of Short Form-36
기간: Up to 6 weeks
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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
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Feasibility of a couple-based yoga program determined by adherence
기간: Up to 6 weeks
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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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Preliminary evidence of intervention efficacy, measured by answers on change in quality of life (QOL): SF-36 questionnaire
기간: Up to 6 weeks
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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
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Kathrin Milbury, MA,PHD, M.D. Anderson Cancer Center
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정된)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 2015-0013
- 2015-0013 (기타 식별자: M D Anderson Cancer Center)
- NCI-2015-01124 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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