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Yoga Therapy in Treating Patients With Malignant Brain Tumors

Primary Purpose

Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Meningioma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
yoga therapy
questionnaire administration
quality-of-life assessment
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Adult Anaplastic Astrocytoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Comprehensive Cancer Center of Wake Forest University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (yoga therapy)

Arm Description

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.

Outcomes

Primary Outcome Measures

Estimate the participation rate, accrual, adherence, and retention to a yoga trial in patients with malignant brain tumors
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
Depressive symptoms
Distress
Health-related quality of life
Preliminary estimates of the efficacy of a yoga intervention in patients with malignant brain tumors on the outcomes of fatigue, distress, and cognitive function
Standardize the cancer-specific yoga protocol for use with brain tumor patients

Full Information

First Posted
November 3, 2010
Last Updated
July 2, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01234805
Brief Title
Yoga Therapy in Treating Patients With Malignant Brain Tumors
Official Title
Yoga and Brain Cancer: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Slow Accruals
Study Start Date
December 2010 (Actual)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (yoga therapy)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
yoga therapy
Other Intervention Name(s)
yoga
Intervention Description
Participates in yoga classes and yoga at home
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Estimate the participation rate, accrual, adherence, and retention to a yoga trial in patients with malignant brain tumors
Description
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.
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Self-reported fatigue
Time Frame
Up to 12 weeks
Title
Depressive symptoms
Time Frame
Up to 12 weeks
Title
Distress
Time Frame
Up to 12 weeks
Title
Health-related quality of life
Time Frame
Up to 12 weeks
Title
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
Title
Standardize the cancer-specific yoga protocol for use with brain tumor patients
Time Frame
At the end of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Danhauer
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Comprehensive Cancer Center of Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

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Yoga Therapy in Treating Patients With Malignant Brain Tumors

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