Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Yoga Therapy in Treating Patients With Malignant Brain Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01234805
Recruitment Status : Terminated (Slow Accruals)
First Posted : November 4, 2010
Last Update Posted : July 3, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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

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

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.

Layout table for study information
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
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Self-reported fatigue [ Time Frame: Up to 12 weeks ]
  2. Depressive symptoms [ Time Frame: Up to 12 weeks ]
  3. Distress [ Time Frame: Up to 12 weeks ]
  4. Health-related quality of life [ Time Frame: Up to 12 weeks ]
  5. 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 ]
  6. Standardize the cancer-specific yoga protocol for use with brain tumor patients [ Time Frame: At the end of therapy ]


Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, North Carolina
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Suzanne Danhauer Wake Forest University Health Sciences
Layout table for additonal information
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Glioblastoma
Glioma
Brain Neoplasms
Astrocytoma
Ependymoma
Gliosarcoma
Meningioma
Medulloblastoma
Oligodendroglioma
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Choroid Plexus Neoplasms
Pinealoma
Hemangiopericytoma
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
Meningeal Neoplasms