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NCT Number: NCT02481349

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice

Other

Undergo standard of care

Other names: standard of care, standard therapy

Informational intervention

Other

Receive DVD for home practice

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

yoga

Other

Complete couple-based Hatha yoga program

Other names: Yoga Therapy

Primary outcomes

  1. Feasibility of a couple-based yoga program, determined by overall accrual

    Time frame: Up to 6 weeks

  2. Feasibility of a couple-based yoga program, determined by attrition using the Mental Component Summary of Short Form-36

    Time frame: 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.

  3. Feasibility of a couple-based yoga program determined by adherence

    Time frame: 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

  4. Feasibility of a couple-based yoga program, determined by incidence of adverse events and serious adverse events

    Time frame: Up to 6 weeks

Secondary outcomes

  1. Preliminary evidence of intervention efficacy, measured by answers on change in quality of life (QOL): SF-36 questionnaire

    Time frame: 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

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Couple-Based Yoga Program for Glioma Patients and Their Partners

Important dates

Study start
2015
Primary completion
2027
Study completion
2027
First posted
Jun 25, 2015
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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