Couples-Based Yoga Program in Improving Quality of Life in Patients With High-Grade Glioma Undergoing Radiation Therapy and Their Partners
- Conditions
- GliomaCaregiver
- Interventions
- Other: Best PracticeOther: Informational InterventionOther: Quality-of-Life AssessmentOther: Questionnaire AdministrationOther: Yoga
- Registration Number
- NCT02481349
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 216
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm II (waitlist control) Quality-of-Life Assessment Patients receive standard of care provided by the health care team and complete questionnaires before and after radiation therapy. Arm I (couple-based Hatha yoga program) Yoga 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. Arm II (waitlist control) Best Practice Patients receive standard of care provided by the health care team and complete questionnaires before and after radiation therapy. Arm I (couple-based Hatha yoga program) Quality-of-Life Assessment 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. Arm I (couple-based Hatha yoga program) Informational Intervention 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. Arm I (couple-based Hatha yoga program) Questionnaire Administration 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. Arm II (waitlist control) Questionnaire Administration Patients receive standard of care provided by the health care team and complete questionnaires before and after radiation therapy.
- Primary Outcome Measures
Name Time Method Feasibility of a couple-based yoga program, determined by attrition using the Mental Component Summary of Short Form-36 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 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 Feasibility of a couple-based yoga program determined by adherence 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
- Secondary Outcome Measures
Name Time Method Preliminary evidence of intervention efficacy, measured by answers on change in quality of life (QOL): SF-36 questionnaire 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
Trial Locations
- Locations (1)
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States