Couples-Based Yoga Program in Improving Quality of Life in Patients With High-Grade Glioma Undergoing Radiation Therapy and Their Partners
Status: | Recruiting |
---|---|
Conditions: | Depression, Insomnia Sleep Studies, Other Indications, Brain Cancer |
Therapuetic Areas: | Oncology, Psychiatry / Psychology, Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/3/2018 |
Start Date: | June 16, 2015 |
End Date: | June 1, 2019 |
Contact: | Kathrin Milbury |
Email: | kmilbury@mdanderson.org |
Phone: | 713-745-2868 |
Couple-Based Yoga Program for Glioma Patients 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.
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.
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.
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.
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
We found this trial at
1
site
Houston, Texas 77030
Principal Investigator: Kathrin Milbury
Phone: 713-745-2868
Click here to add this to my saved trials
