Clinical Trial: Yoga Therapy in Treating Patients With Malignant Brain Tumors
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Yoga and Brain Cancer: A Feasibility Study
Brief Summary: This clinical trial studies yoga therapy in treating patients with malignant brain tumors. Yoga therapy may improve the quality of life of patients with brain tumors
Detailed Summary:
PRIMARY OBJECTIVES:
I. To estimate the participation rate, accrual, adherence, and retention to a yoga trial in patients with malignant brain tumors.
SECONDARY OBJECTIVES:
I. To obtain estimates of the variability of self-reported fatigue, distress (i.e., depression, anxiety), sleep disturbance, cognitive function, and health-related quality of life from baseline to the end of the intervention at 6 (post-onsite intervention) and 12 weeks (post-full intervention).
II. To obtain preliminary estimates of the efficacy of a yoga intervention in patients with malignant brain tumors on the outcomes of fatigue, distress, and cognitive function.
III. To standardize the cancer-specific yoga protocol for use with brain tumor patients.
OUTLINE:
Patients participate in yoga classes comprising postures, deep relaxation, breathing practices, and meditation twice weekly for 75 minutes during weeks 1-6. Patients then practice yoga at home twice weekly for 45 minutes during weeks 7-12.
After completion of study treatment, patients are followed up periodically for 4-5 months.
Sponsor: Wake Forest University Health Sciences
Current Primary Outcome: Estimate the participation rate, accrual, adherence, and retention to a yoga trial in patients with malignant brain tumors [ Time Frame: Up to 12 weeks ]
Original Primary Outcome: Estimate the participation rate, accrual, adherence, and retention to a yoga trial in patients with malignant brain tumors [ Time Frame: Periodically during study treatment ]
Current Secondary Outcome:
- Self-reported fatigue [ Time Frame: Up to 12 weeks ]
- Depressive symptoms [ Time Frame: Up to 12 weeks ]
- Distress [ Time Frame: Up to 12 weeks ]
- Health-related quality of life [ Time Frame: Up to 12 weeks ]
- Preliminary estimates of the efficacy of a yoga intervention in patients with malignant brain tumors on the outcomes of fatigue, distress, and cognitive function [ Time Frame: Up to 12 weeks ]
- Standardize the cancer-specific yoga protocol for use with brain tumor patients [ Time Frame: At the end of therapy ]
Original Secondary Outcome:
- Self-reported fatigue [ Time Frame: At weeks 0, 6, and 12 ]
- Depressive symptoms [ Time Frame: At weeks 0, 6, and 12 ]
- Distress [ Time Frame: At weeks 0, 6, and 12 ]
- Health-related quality of life [ Time Frame: At weeks 0, 6, and 12 ]
- Preliminary estimates of the efficacy of a yoga intervention in patients with malignant brain tumors on the outcomes of fatigue, distress, and cognitive function [ Time Frame: After completion of study treatment ]
- Standardize the cancer-specific yoga protocol for use with brain tumor patients [ Time Frame: After completion of study treatment ]
Information By: Wake Forest University Health Sciences
Dates:
Date Received: November 3, 2010
Date Started: December 2010
Date Completion:
Last Updated: January 17, 2017
Last Verified: September 2012