Couple-Based Yoga Program for Glioma Patients and Their Partners
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Feasibility of a couple-based yoga program, determined by attrition using the Mental Component Summary of Short Form-36
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Informational Intervention (Other)
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.
干预措施: Quality-of-Life Assessment (Other)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Yoga (Other)
Arm II (waitlist control)
Patients receive standard of care provided by the health care team and complete questionnaires before and after radiation therapy.
干预措施: Best Practice (Other)
Arm II (waitlist control)
Patients receive standard of care provided by the health care team and complete questionnaires before and after radiation therapy.
干预措施: Quality-of-Life Assessment (Other)
Arm II (waitlist control)
Patients receive standard of care provided by the health care team and complete questionnaires before and after radiation therapy.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Feasibility of a couple-based yoga program, determined by attrition using the Mental Component Summary of Short Form-36
时间窗: 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.
Feasibility of a couple-based yoga program, determined by overall accrual
时间窗: Up to 6 weeks
Feasibility of a couple-based yoga program, determined by incidence of adverse events and serious adverse events
时间窗: Up to 6 weeks
Feasibility of a couple-based yoga program determined by adherence
时间窗: 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
次要结局
- Preliminary evidence of intervention efficacy, measured by answers on change in quality of life (QOL): SF-36 questionnaire(Up to 6 weeks)