Yoga Therapy in Treating Patients With Malignant Brain Tumors

Wake Forest University Health Sciences9 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Adult Anaplastic Astrocytoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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.

Time frame: Up to 12 weeks

Secondary Outcomes

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

Yoga Therapy in Treating Patients With Malignant Brain Tumors

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes