Couples-Based Yoga Program in Improving Quality of Life in Patients With High-Grade Glioma Undergoing Radiation Therapy and Their Partners

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Couple-Based Yoga Program for Glioma Patients and Their Partners

Conditions
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Caregiver, Glioma

Intervention / Treatment
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* Other: Best Practice
* Other: Informational Intervention
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
* Other: Yoga


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (couple-based Hatha yoga program)<br>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. | Other: Informational Intervention<br>* Receive DVD for home practice<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Yoga<br>* Complete couple-based Hatha yoga program<br>* Other names: Yoga Therapy;|
| Active Comparator: Arm II (waitlist control)<br>Patients receive standard of care provided by the health care team and complete questionnaires before and after radiation therapy. | Other: Best Practice<br>* Undergo standard of care<br>* Other names: standard therapy;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of a couple-based yoga program, determined by overall accrual |  | Up to 6 weeks | 
| Feasibility of a couple-based yoga program, determined by attrition using the Mental Component Summary of Short Form-36 | 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 | 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 | 
| Feasibility of a couple-based yoga program, determined by incidence of adverse events and serious adverse events |  | Up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preliminary evidence of intervention efficacy, measured by answers on change in quality of life (QOL): SF-36 questionnaire | 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 |