Yoga Therapy in Treating Patients With Malignant Brain Tumors
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Purpose
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 | Intervention |
|---|---|
|
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 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Yoga and Brain Cancer: A Feasibility Study |
- Estimate the participation rate, accrual, adherence, and retention to a yoga trial in patients with malignant brain tumors [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]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.
- Self-reported fatigue [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
- Depressive symptoms [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
- Distress [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
- Health-related quality of life [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Standardize the cancer-specific yoga protocol for use with brain tumor patients [ Time Frame: At the end of therapy ] [ Designated as safety issue: No ]
| Enrollment: | 9 |
| Study Start Date: | December 2010 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: yoga
Other: questionnaire administration
Ancillary studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| United States, North Carolina | |
| Comprehensive Cancer Center of Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157 | |
| Principal Investigator: | Suzanne Danhauer | Comprehensive Cancer Center of Wake Forest University |
More Information
No publications provided
| Responsible Party: | Comprehensive Cancer Center of Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT01234805 History of Changes |
| Other Study ID Numbers: | CCCWFU 98410, NCI-2010-02044 |
| Study First Received: | November 3, 2010 |
| Last Updated: | September 28, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Oligodendroglioma Astrocytoma Brain Neoplasms Ependymoma Glioblastoma Glioma Hemangiopericytoma Medulloblastoma Meningioma Pinealoma Choroid Plexus Neoplasms Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Gliosarcoma Neoplasms, Neuroepithelial |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases Neoplasms, Vascular Tissue Meningeal Neoplasms Cerebral Ventricle Neoplasms |
ClinicalTrials.gov processed this record on May 16, 2013