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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
216
M D Anderson Cancer Center
Houston, Texas, United States
Feasibility of a couple-based yoga program, determined by overall accrual
Time frame: 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.
Time frame: 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
Time frame: Up to 6 weeks
Feasibility of a couple-based yoga program, determined by incidence of adverse events and serious adverse events
Time frame: Up to 6 weeks
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
Time frame: Up to 6 weeks
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Ancillary studies
Complete couple-based Hatha yoga program