Yoga Therapy in Treating Patients With Malignant Brain Tumors

NCT01234805 | Terminated

• 3 other identifiers: IRB00015038NCI-2010-02044CCCWFU 98410
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 12 weeks

Secondary Outcomes (6)

• Self-reported fatigue

  Up to 12 weeks

• Depressive symptoms

  Up to 12 weeks

• Distress

  Up to 12 weeks

• Health-related quality of life

  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

  Up to 12 weeks

Study Arms (1)

Supportive care (yoga therapy)

EXPERIMENTAL

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; Other: questionnaire administration; Procedure: quality-of-life assessment

Interventions

yoga therapy PROCEDURE

Participates in yoga classes and yoga at home

Also known as: yoga

Supportive care (yoga therapy)

questionnaire administration OTHER

Ancillary studies

Supportive care (yoga therapy)

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Supportive care (yoga therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Astrocytoma; Ependymoma; Meningioma; Oligodendroglioma; Choroid Plexus Neoplasms; Neuroectodermal Tumors, Primitive; Glioblastoma; Gliosarcoma; Medulloblastoma; Glioma; Pinealoma; Brain Neoplasms

Interventions

Yoga

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases; Cerebral Ventricle Neoplasms; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Suzanne Danhauer

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2010
• First Posted: November 4, 2010
• Study Start: December 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: July 3, 2018

Record last verified: 2018-07

Locations

US (1)