Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT00376818
Status:
COMPLETED
Last Update Posted:
2012-06-04
First Post:
2006-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stress Reduction Program in Patients With Malignant Brain Tumors and Their Family Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D004806', 'term': 'Ependymoma'}, {'id': 'D009837', 'term': 'Oligodendroglioma'}, {'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D018316', 'term': 'Gliosarcoma'}, {'id': 'D008527', 'term': 'Medulloblastoma'}, {'id': 'D008579', 'term': 'Meningioma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D008577', 'term': 'Meningeal Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015013', 'term': 'Yoga'}, {'id': 'D018479', 'term': 'Early Intervention, Educational'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D019122', 'term': 'Meditation'}], 'ancestors': [{'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'}, {'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D012064', 'term': 'Relaxation Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-01', 'studyFirstSubmitDate': '2006-09-13', 'studyFirstSubmitQcDate': '2006-09-13', 'lastUpdatePostDateStruct': {'date': '2012-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Items (EORTC QLQ-C30) and Brain Cancer Module-20', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Decrease in perception of stress and anxiety in patients and their primary family caregivers as measured by the Perceived Stress Scale and Beck Anxiety Inventory questionnaires', 'timeFrame': '12 months'}, {'measure': 'Decrease in stress- and inflammation-related hormones in patients and their primary family caregivers as measured by saliva samples', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['psychosocial effects of cancer and its treatment', 'adult anaplastic astrocytoma', 'adult anaplastic ependymoma', 'adult anaplastic oligodendroglioma', 'adult giant cell glioblastoma', 'adult gliosarcoma', 'adult medulloblastoma', 'adult anaplastic meningioma', 'adult papillary meningioma', 'adult mixed glioma', 'recurrent adult brain tumor', 'adult glioblastoma', 'adult grade III meningioma'], 'conditions': ['Brain and Central Nervous System Tumors', 'Psychosocial Effects of Cancer and Its Treatment']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Yoga, meditation, and breathing exercises may help lower stress and improve quality of life in patients with malignant brain tumors and their family caregivers.\n\nPURPOSE: This clinical trial is studying how well a stress reduction program works to improve the quality of life of patients with malignant brain tumors and their family caregivers.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine whether regular practice of a stress reduction program for 8 weeks improves the quality of life of patients with malignant brain tumors.\n\nSecondary\n\n* Determine whether regular practice of a stress reduction routine decreases perception of stress and anxiety and stress- and inflammation-related hormones in both patients with malignant brain tumors and their primary family caregivers.\n\nOUTLINE: This is a pilot study.\n\nPatients and caregivers receive a 90-minute stress-reduction session once a week for 8 weeks. Each session comprises an educational session on stress reduction and yoga therapy comprising specific yoga postures, breathing exercises, and relaxation and meditation.\n\nQuality of life, stress, anxiety, and levels of stress-related hormones (cortisol, dehydroepiandrosterone sulfate \\[DHEAS\\], and melatonin) are assessed at baseline and at week 8.\n\nAfter completion of study treatment, patients and caregivers are followed at 6 and 12 months.\n\nPROJECTED ACCRUAL: A total of 14 caregiver/patient pairs will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed malignant brain tumor of 1 of the following subtypes:\n\n * Anaplastic astrocytoma\n * Glioblastoma multiforme\n * Astrocytoma WHO grade IV\n * Malignant meningioma\n * Anaplastic oligodendroglioma\n * Anaplastic oligoastrocytoma\n * Gliosarcoma\n * Anaplastic ependymoma\n * Medulloblastoma\n* Caregivers must meet the following criteria:\n\n * Primary family caregiver\n * Age 18 and over\n\nPATIENT CHARACTERISTICS:\n\n* Karnofsky performance status 70-100%\\*\n* Absolute neutrophil count ≥ 1,500/mm³\\*\n* Platelet count ≥ 100,000/mm³\\*\n* Bilirubin ≤ 2 times normal\\*\n* Alkaline phosphatase ≤ 2 times normal\\*\n* SGOT ≤ 3 times normal\\*\n* BUN or creatinine ≤ 1.5 times normal\\*\n* No other prior (within the past 3 years) or concurrent malignancies except for surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer\\*\n* Not pregnant\\*\\*\n* Negative pregnancy test\\*\\*\n* Fertile patients must use effective contraception\\*\\*\n* No active infection\\*\\*\n* No medical condition that would interfere with the practice of yoga and meditation\\*\\* NOTE: \\*Patient\n\nNOTE: \\*\\*Patient and caregiver\n\nPRIOR CONCURRENT THERAPY:\n\n* No other prior or concurrent stress reduction techniques using yoga or meditation\\*\n* Concurrent standard or investigational chemotherapy, hormonal therapy, immunotherapy, biologic agents, or other complementary and alternative therapies as the primary or adjuvant treatment allowed (patient)\n* No concurrent glucocorticoids (caregiver)\n* Concurrent dexamethasone allowed provided the daily dose is \\< 2 mg/day (patient)\n* No concurrent dehydroepiandrosterone sulfate (DHEAS) and/or melatonin supplements\\* NOTE: \\*Patient and caregiver'}, 'identificationModule': {'nctId': 'NCT00376818', 'briefTitle': 'Stress Reduction Program in Patients With Malignant Brain Tumors and Their Family Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'Evaluation of a Stress Reduction Program in Patients With Malignant Brain Tumors and Their Family Caregivers', 'orgStudyIdInfo': {'id': 'CASE2306'}, 'secondaryIdInfos': [{'id': 'P30CA043703', 'link': 'https://reporter.nih.gov/quickSearch/P30CA043703', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'exercise intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Yoga'], 'description': 'All participants will convene once per week for 8 weeks for a 90-minute session that will be based on yoga principles for a stress reduction.'}, {'name': 'educational intervention', 'type': 'OTHER', 'description': 'A 15-minute educational session on a particular topic (mind-body connection; fight or flight response; relaxation response; the science and philosophy of yoga; the science of meditation; sleeping well; mindfulness; the healer within - how to harness your innate healing potential).'}, {'name': 'physiologic testing', 'type': 'OTHER', 'otherNames': ['questionnaire'], 'description': 'Both patients and family caregivers will complete Perceived Stress Scale (PSS) and Beck Anxiety Inventory (BAI) questionnaires.'}, {'name': 'management of therapy complications', 'type': 'OTHER', 'otherNames': ['questionnaire'], 'description': 'Brain Cancer module-20 questionnaire to assesses problems specific to brain tumor.'}, {'name': 'mind-body intervention procedure', 'type': 'BEHAVIORAL', 'otherNames': ['Meditation'], 'description': 'Meditation practice in this study will consist of 15 minutes of "body scan" to completely relax the body from head to toe and will be followed by 15 minute silence during which the study participants will maintain awareness of their breath, bodily sensations and thoughts as they spontaneously arise. The remainder of the class will be devoted to a group discussion of personal reflections and challenges.'}, {'name': 'Measurement of stress-related hormones', 'type': 'PROCEDURE', 'otherNames': ['salivary samples'], 'description': 'Measurements of stress-related hormones: Stress hormones cortisol, dehydroepiandrosterone sulfate (DHEAS) and melatonin will be measured in saliva because their levels in saliva accurately reflect blood levels (Carlson et al, 2004). The non-invasive saliva collection method by cotton swabs (Salivette® by Sardstedt Inc.) will be used in this study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Taussig Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Glen H. J. Stevens, DO, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}