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

Glioma Clinical Trial

Official title:

Couple-Based Yoga Program for Glioma Patients and Their Partners

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02481349
• Other study ID #: 2015-0013
• Secondary ID: NCI-2015-0112420
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 16, 2015
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 216
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Caregiver
• Glioma

Intervention

Other:
• Best Practice
Undergo standard of care
• Informational Intervention
Receive DVD for home practice
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies
• Yoga
Complete couple-based Hatha yoga program

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of a couple-based yoga program, determined by overall accrual		Up to 6 weeks
Primary	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
Primary	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
Primary	Feasibility of a couple-based yoga program, determined by incidence of adverse events and serious adverse events		Up to 6 weeks
Secondary	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

External Links

•   MD Anderson Cancer Center Website