Yoga Therapy in Treating Patients With Malignant Brain Tumors

Yoga Therapy in Treating Patients With Malignant Brain Tumors
This study is not yet open for participant recruitment.
Verified March 2012 by Comprehensive Cancer Center of Wake Forest University

First Received on November 3, 2010.  
Last Updated on March 9, 2012  
History of Changes
Sponsor: Comprehensive Cancer Center of Wake Forest University
Collaborator: National Cancer Institute (NCI)
Information provided by (Responsible Party): Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01234805
  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

Resource links provided by NLM:

Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:

  • 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.

Secondary Outcome Measures:

  • 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 ]

Estimated Enrollment: 20
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
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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01234805

Locations
United States, North Carolina
Comprehensive Cancer Center of Wake Forest University Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Suzanne C. Danhauer     336-716-7402     danhauer@wfubmc.edu    
Principal Investigator: Suzanne C. Danhauer            
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
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: March 9, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:

Astrocytoma
Brain Neoplasms
Ependymoma
Glioblastoma
Glioma
Hemangiopericytoma
Medulloblastoma
Meningioma
Oligodendroglioma
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 August 21, 2012

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