Yoga Therapy in Treating Patients With Malignant Brain Tumors

Wake Forest University (WFU)

Status: Terminated

Conditions: Adult Medulloblastoma; Adult Anaplastic Ependymoma; Adult Brain Stem Glioma; Adult Ependymoblastoma; Adult Diffuse Astrocytoma; Adult Glioblastoma; Adult Supratentorial Primitive Neuroectodermal Tumor (PNET); Adult Anaplastic Astrocytoma; Adult Pineal Gland Astrocytoma; Adult Giant Cell Glioblastoma; Adult Pineocytoma; Adult Mixed Glioma; Adult Ependymoma; Adult Grade II Meningioma; Adult Meningeal Hemangiopericytoma; Adult Anaplastic Meningioma; Adult Oligodendroglioma; Adult Choroid Plexus Tumor; Adult Anaplastic Oligodendroglioma; Recurrent Adult Brain Tumor; Adult Pineoblastoma; Adult Papillary Meningioma; Adult Gliosarcoma

Treatments: Other: questionnaire administration; Procedure: quality-of-life assessment; Procedure: yoga therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01234805

CCCWFU 98410 (Other Identifier)

NCI-2010-02044 (Registry Identifier)

IRB00015038

Details and patient eligibility

About

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

Full description

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Supportive care (yoga therapy)

Experimental group

Description:

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.

Treatment:

Procedure: yoga therapy

Other: questionnaire administration

Procedure: quality-of-life assessment