M D Anderson Cancer Center
Houston, Texas, 77030, United States
NCT Number: NCT02481349
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Houston, Texas, 77030, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Undergo standard of care
Other names: standard of care, standard therapy
Receive DVD for home practice
Ancillary studies
Other names: Quality of Life Assessment
Ancillary studies
Complete couple-based Hatha yoga program
Other names: Yoga Therapy
Time frame: Up to 6 weeks
Time frame: 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.
Time frame: 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
Time frame: Up to 6 weeks
Time frame: 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
M.D. Anderson Cancer Center
Other
Couple-Based Yoga Program for Glioma Patients and Their Partners
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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