Clinical trial NCT02481349: Couples-Based Yoga Program in Improving Quality of Life in Patients With High-Grade Glioma Undergoing Radiation Therapy and Their Partners
Official title: Couple-Based Yoga Program for Glioma Patients and Their Partners
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Caregiver
Glioma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-06-25
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of a couple-based yoga program, determined by overall accrual
timeFrame: Up to 6 weeks
measure: Feasibility of a couple-based yoga program, determined by attrition using the Mental Component Summary of Short Form-36
timeFrame: Up to 6 weeks
measure: Feasibility of a couple-based yoga program determined by adherence
timeFrame: Up to 6 weeks
measure: Feasibility of a couple-based yoga program, determined by incidence of adverse events and serious adverse events
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Preliminary evidence of intervention efficacy, measured by answers on change in quality of life (QOL): SF-36 questionnaire
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Kathrin Milbury, MA,PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.