Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT01234805
Status:
TERMINATED
Last Update Posted:
2018-07-03
First Post:
2010-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Yoga Therapy in Treating Patients With Malignant Brain Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D004806', 'term': 'Ependymoma'}, {'id': 'D008579', 'term': 'Meningioma'}, {'id': 'D009837', 'term': 'Oligodendroglioma'}, {'id': 'D016545', 'term': 'Choroid Plexus Neoplasms'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D018316', 'term': 'Gliosarcoma'}, {'id': 'D008527', 'term': 'Medulloblastoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D010871', 'term': 'Pinealoma'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D008577', 'term': 'Meningeal Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002551', 'term': 'Cerebral Ventricle Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015013', 'term': 'Yoga'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'Slow Accruals', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-02', 'studyFirstSubmitDate': '2010-11-03', 'studyFirstSubmitQcDate': '2010-11-03', 'lastUpdatePostDateStruct': {'date': '2018-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimate the participation rate, accrual, adherence, and retention to a yoga trial in patients with malignant brain tumors', 'timeFrame': 'Up to 12 weeks', '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.'}], 'secondaryOutcomes': [{'measure': 'Self-reported fatigue', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Depressive symptoms', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Distress', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Health-related quality of life', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Preliminary estimates of the efficacy of a yoga intervention in patients with malignant brain tumors on the outcomes of fatigue, distress, and cognitive function', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Standardize the cancer-specific yoga protocol for use with brain tumor patients', 'timeFrame': 'At the end of therapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To estimate the participation rate, accrual, adherence, and retention to a yoga trial in patients with malignant brain tumors.\n\nSECONDARY OBJECTIVES:\n\nI. 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).\n\nII. 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.\n\nIII. To standardize the cancer-specific yoga protocol for use with brain tumor patients.\n\nOUTLINE:\n\nPatients 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.\n\nAfter completion of study treatment, patients are followed up periodically for 4-5 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSigned 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\n\nExclusion Criteria:\n\nHave 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'}, 'identificationModule': {'nctId': 'NCT01234805', 'briefTitle': 'Yoga Therapy in Treating Patients With Malignant Brain Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Yoga and Brain Cancer: A Feasibility Study', 'orgStudyIdInfo': {'id': 'IRB00015038'}, 'secondaryIdInfos': [{'id': 'NCI-2010-02044', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CCCWFU 98410', 'type': 'OTHER', 'domain': 'Wake Forest University Health Sciences'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supportive care (yoga therapy)', '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.', 'interventionNames': ['Procedure: yoga therapy', 'Other: questionnaire administration', 'Procedure: quality-of-life assessment']}], 'interventions': [{'name': 'yoga therapy', 'type': 'PROCEDURE', 'otherNames': ['yoga'], 'description': 'Participates in yoga classes and yoga at home', 'armGroupLabels': ['Supportive care (yoga therapy)']}, {'name': 'questionnaire administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive care (yoga therapy)']}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE', 'otherNames': ['quality of life assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive care (yoga therapy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Comprehensive Cancer Center of Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Suzanne Danhauer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}