Yoga Therapy in Treating Patients With Malignant Brain Tumors

This study has been terminated.
(Slow Accruals)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01234805
First received: November 3, 2010
Last updated: September 28, 2012
Last verified: September 2012

November 3, 2010
September 28, 2012
December 2010
December 2013   (final data collection date for primary outcome measure)
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.
Estimate the participation rate, accrual, adherence, and retention to a yoga trial in patients with malignant brain tumors [ Time Frame: Periodically during study treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01234805 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Self-reported fatigue [ Time Frame: At weeks 0, 6, and 12 ] [ Designated as safety issue: No ]
  • Depressive symptoms [ Time Frame: At weeks 0, 6, and 12 ] [ Designated as safety issue: No ]
  • Distress [ Time Frame: At weeks 0, 6, and 12 ] [ Designated as safety issue: No ]
  • Health-related quality of life [ Time Frame: At weeks 0, 6, and 12 ] [ 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: After completion of study treatment ] [ Designated as safety issue: No ]
  • Standardize the cancer-specific yoga protocol for use with brain tumor patients [ Time Frame: After completion of study treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Yoga Therapy in Treating Patients With Malignant Brain Tumors
Yoga and Brain Cancer: A Feasibility Study

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

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • 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
    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
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.
Interventions:
  • Procedure: yoga therapy
  • Other: questionnaire administration
  • Procedure: quality-of-life assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
Not Provided
December 2013   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01234805
CCCWFU 98410, NCI-2010-02044
No
Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Principal Investigator: Suzanne Danhauer Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP