Yoga Therapy in Treating Patients With Malignant Brain Tumors
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| ClinicalTrials.gov Identifier: NCT01234805 |
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Recruitment Status :
Terminated
(Slow Accruals)
First Posted : November 4, 2010
Last Update Posted : July 3, 2018
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| 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 | Not Applicable |
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 (Clinical Trial) |
| 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 : | December 2010 |
| Actual Primary Completion Date : | September 2012 |
| Actual Study Completion Date : | September 2012 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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 |
- Estimate the participation rate, accrual, adherence, and retention to a yoga trial in patients with malignant brain tumors [ Time Frame: 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.
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01234805
| United States, North Carolina | |
| Comprehensive Cancer Center of Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157 | |
| Principal Investigator: | Suzanne Danhauer | Wake Forest University Health Sciences |
| Responsible Party: | Wake Forest University Health Sciences |
| ClinicalTrials.gov Identifier: | NCT01234805 |
| Other Study ID Numbers: |
IRB00015038 NCI-2010-02044 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) CCCWFU 98410 ( Other Identifier: Wake Forest University Health Sciences ) |
| First Posted: | November 4, 2010 Key Record Dates |
| Last Update Posted: | July 3, 2018 |
| Last Verified: | July 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Neoplasms Glioblastoma Glioma Brain Neoplasms Astrocytoma Ependymoma Meningioma Gliosarcoma Medulloblastoma Oligodendroglioma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Choroid Plexus Neoplasms Pinealoma Hemangiopericytoma |
Solitary Fibrous Tumors Sarcoma, Ewing Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Neuroepithelial Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type 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 |