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

NCT02481349 | Active Not Recruiting DMC

• 2 other identifiers: 2015-0013NCI-2015-01124
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregiver; Glioma

Outcome Measures

Primary Outcomes (4)

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

  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.

  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

  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

Secondary Outcomes (1)

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

  Up to 6 weeks

Study Arms (2)

Arm I (couple-based Hatha yoga program)

EXPERIMENTAL

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.

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

Arm II (waitlist control)

ACTIVE COMPARATOR

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

Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Undergo standard of care

Also known as: standard of care, standard therapy

Arm II (waitlist control)

Informational Intervention OTHER

Receive DVD for home practice

Arm I (couple-based Hatha yoga program)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (couple-based Hatha yoga program); Arm II (waitlist control)

Questionnaire Administration OTHER

Ancillary studies

Arm I (couple-based Hatha yoga program); Arm II (waitlist control)

Yoga OTHER

Complete couple-based Hatha yoga program

Also known as: Yoga Therapy

Arm I (couple-based Hatha yoga program)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (3)

• Snyder S, Silva RF, Whisenant MS, Milbury K. Videoconferenced Yoga Interventions for Cancer Patients and their Caregivers during the COVID-19 Pandemic: A Report from a Clinician's Perspective. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211019111. doi: 10.1177/15347354211019111.

  PMID: 34036820 DERIVED

• Milbury K, Li J, Weathers SP, Mallaiah S, Armstrong T, Li Y, Bruera E, Cohen L. Pilot randomized, controlled trial of a dyadic yoga program for glioma patients undergoing radiotherapy and their family caregivers. Neurooncol Pract. 2019 Jul;6(4):311-320. doi: 10.1093/nop/npy052. Epub 2018 Dec 20.

  PMID: 31386042 DERIVED

• Milbury K, Li J, Weathers SP, Shih T, Malliaha S, Li Y, Cohen L. A research protocol for a pilot, randomized controlled trial designed to examine the feasibility of a dyadic versus individual yoga program for family caregivers of glioma patients undergoing radiotherapy. Pilot Feasibility Stud. 2019 Jul 25;5:95. doi: 10.1186/s40814-019-0479-5. eCollection 2019.

  PMID: 31367462 DERIVED

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Glioma

Interventions

Practice Guidelines as Topic; Standard of Care; Yoga

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Kathrin Milbury, MA,PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2015
• First Posted: June 25, 2015
• Study Start: June 16, 2015
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)