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

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Glioma; Caregiver

Treatments: Other: Informational Intervention; Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Other: Yoga; Other: Best Practice

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02481349

2015-0013 (Other Identifier)

NCI-2015-01124 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 216 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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216 participants in 2 patient groups

Arm I (couple-based Hatha yoga program)

Experimental group

Description:

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.

Treatment:

Other: Yoga

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Other: Informational Intervention

Arm II (waitlist control)

Active Comparator group

Description:

Patients receive standard of care provided by the health care team and complete questionnaires before and after radiation therapy.

Treatment:

Other: Best Practice

Other: Questionnaire Administration

Other: Quality-of-Life Assessment