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

Conditions

Caregiver, Glioma

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.

Kathrin Milbury, Jing Li, Shiao‐Pei Weathers, Rosangela Silva, Stella Snyder et al. (9 authors)

Journal of Clinical Oncology2021-09-212 citations

10.1200/jco.2020.39.28_suppl.156

Videoconferenced Yoga Interventions for Cancer Patients and their Caregivers during the COVID-19 Pandemic: A Report from a Clinician’s Perspective

Stella Snyder, Rosangela F. Silva, Meagan Whisenant, Kathrin Milbury

Integrative Cancer Therapies2021-01-0123 citations

10.1177/15347354211019111

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.

Milbury K, Li J, Weathers SP, Shih T, Malliaha S, Li Y, Cohen L.

2019-07-251 citations

10.1186/s40814-019-0479-5

Pilot randomized, controlled trial of a dyadic yoga program for glioma patients undergoing radiotherapy and their family caregivers

Kathrin Milbury, Jing Li, Shiao-Pei Weathers, Smitha Mallaiah, Terri Armstrong et al. (8 authors)

Neuro-Oncology Practice2018-12-2055 citations

10.1093/nop/npy052

Interventions

OTHERBest Practice

Undergo standard of care

OTHERInformational Intervention

Receive DVD for home practice

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies

OTHERYoga

Complete couple-based Hatha yoga program

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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	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.
Feasibility of a couple-based yoga program determined by adherence	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
Feasibility of a couple-based yoga program, determined by incidence of adverse events and serious adverse events	Up to 6 weeks	—

Secondary

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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKathrin Milbury, MA,PHD

M.D. Anderson Cancer Center

Outcome results

None listed