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 ]

Track barriers to recruitment. Participation rate calculated as proportion of eligible patients who agree to participate. Study retention estimated as proportion of participating patients who complete questionnaires at Week 6. Further retention data obtained by tracking # of dropouts, when dropout occurs, & reasons for dropout. Intervention adherence estimated as mean % of yoga classes attended. Summary statistics for patient characteristics, participation rates, adherence & retention. 95% confidence intervals calculated for each feasibility measure.


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