Yoga Therapy in Treating Patients With Malignant Brain Tumors

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Terminated

CT.gov ID

NCT01234805

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Adult Anaplastic Astrocytoma Adult Anaplastic Ependymoma Adult Anaplastic Meningioma Adult Anaplastic Oligodendroglioma Adult Brain Stem Glioma Adult Choroid Plexus Tumor Adult Diffuse Astrocytoma Adult Ependymoblastoma Adult Ependymoma Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Adult Grade II Meningioma Adult Medulloblastoma Adult Meningeal Hemangiopericytoma Adult Mixed Glioma Adult Oligodendroglioma Adult Papillary Meningioma Adult Pineal Gland Astrocytoma Adult Pineoblastoma Adult Pineocytoma Adult Supratentorial Primitive Neuroectodermal Tumor (PNET) Recurrent Adult Brain Tumor	Procedure: yoga therapy Other: questionnaire administration Procedure: quality-of-life assessment	N/A

Detailed Description

PRIMARY OBJECTIVES:

To estimate the participation rate, accrual, adherence, and retention to a yoga trial in patients with malignant brain tumors.

SECONDARY OBJECTIVES:

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).
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.
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Yoga and Brain Cancer: A Feasibility Study

Actual Study Start Date :

Dec 1, 2010

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Supportive care (yoga therapy) 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.	Procedure: yoga therapy Participates in yoga classes and yoga at home Other Names: yoga Other: questionnaire administration Ancillary studies Procedure: quality-of-life assessment Ancillary studies Other Names: quality of life assessment

Arm

Intervention/Treatment

Experimental: Supportive care (yoga therapy)

Procedure: yoga therapy

Participates in yoga classes and yoga at home

Other Names:

yoga

Other: questionnaire administration

Ancillary studies

Procedure: quality-of-life assessment

Ancillary studies

Other Names:

quality of life assessment

Outcome Measures

Primary Outcome Measures

Estimate the participation rate, accrual, adherence, and retention to a yoga trial in patients with malignant brain tumors [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.

Secondary Outcome Measures

Self-reported fatigue [Up to 12 weeks]
Depressive symptoms [Up to 12 weeks]
Distress [Up to 12 weeks]
Health-related quality of life [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 [Up to 12 weeks]
Standardize the cancer-specific yoga protocol for use with brain tumor patients [At the end of therapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Signed protocol specific informed consent Are diagnosed with a Malignant Brain Tumor (Grades II-IV) Able to start the on-site yoga intervention within 1 week of first radiation treatment Are physically able to attend the intervention classes (Eastern Cooperative Oncology Group [ECOG] performance status rating 0-2) Able to understand written and spoken English Have no medical contraindications reported by the attending physician

Exclusion Criteria:

Have practiced yoga on a regular basis (at least once a week) within the past 4 weeks to recruit participants who are not already regularly practicing yoga; given that the benefits of yoga are likely more immediate than long-term, however, we will enroll participants who have previously had a yoga practice