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
Conditions
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 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.
Interventions
PROCEDUREyoga therapy
Participates in yoga classes and yoga at home
OTHERquestionnaire administration
Ancillary studies
PROCEDUREquality-of-life assessment
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Depressive symptoms | Up to 12 weeks |
| Distress | Up to 12 weeks |
| Self-reported fatigue | 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 |
| Health-related quality of life | Up to 12 weeks |
Countries
United States
Outcome results
None listed