Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-03-01 @ 3:20 AM
Study NCT ID:
NCT03735992
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2018-11-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mind-body Medicine for Patients With Malignant Hematological Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 94}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2018-11-07', 'studyFirstSubmitQcDate': '2018-11-07', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Treatment Expectation', 'timeFrame': 'week 0', 'description': 'Visual Analogue Scale (VAS)'}, {'measure': 'Treatment Satisfaction', 'timeFrame': 'week 12', 'description': 'Client Satisfaction Questionnaire (CSQ)'}], 'primaryOutcomes': [{'measure': 'General Fatigue', 'timeFrame': 'week 12', 'description': 'Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale'}], 'secondaryOutcomes': [{'measure': 'General Fatigue', 'timeFrame': 'week 24', 'description': 'Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale'}, {'measure': 'Physical Fatigue', 'timeFrame': 'week 12', 'description': 'Multidimensional Fatigue Inventory (MFI) - Physical Fatigue Subscale'}, {'measure': 'Physical Fatigue', 'timeFrame': 'week 24', 'description': 'Multidimensional Fatigue Inventory (MFI) - Physical Fatigue Subscale'}, {'measure': 'Reduced Activity', 'timeFrame': 'week 12', 'description': 'Multidimensional Fatigue Inventory (MFI) - Reduced Activity Subscale'}, {'measure': 'Reduced Activity', 'timeFrame': 'week 24', 'description': 'Multidimensional Fatigue Inventory (MFI) - Reduced Activity Subscale'}, {'measure': 'Reduced Motivation', 'timeFrame': 'week 12', 'description': 'Multidimensional Fatigue Inventory (MFI) - Reduced Motivation Subscale'}, {'measure': 'Reduced Motivation', 'timeFrame': 'week 24', 'description': 'Multidimensional Fatigue Inventory (MFI) - Reduced Motivation Subscale'}, {'measure': 'Mental Fatigue', 'timeFrame': 'week 12', 'description': 'Multidimensional Fatigue Inventory (MFI) - Mental Fatigue Subscale'}, {'measure': 'Mental Fatigue', 'timeFrame': 'week 24', 'description': 'Multidimensional Fatigue Inventory (MFI) - Mental Fatigue Subscale'}, {'measure': 'Qaulity of life', 'timeFrame': 'week 12', 'description': 'Functional Assessment of Cancer Therapy - General (FACT-G)'}, {'measure': 'Qaulity of life', 'timeFrame': 'week 24', 'description': 'Functional Assessment of Cancer Therapy - General (FACT-G)'}, {'measure': 'Depression', 'timeFrame': 'week 12', 'description': 'Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)'}, {'measure': 'Depression', 'timeFrame': 'week 24', 'description': 'Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)'}, {'measure': 'Anxiety', 'timeFrame': 'week 12', 'description': 'Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)'}, {'measure': 'Anxiety', 'timeFrame': 'week 24', 'description': 'Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)'}, {'measure': 'Stress', 'timeFrame': 'week 12', 'description': 'Perceived Stress Scale (PSS)'}, {'measure': 'Stress', 'timeFrame': 'week 24', 'description': 'Perceived Stress Scale (PSS)'}, {'measure': 'Sleep', 'timeFrame': 'week 12', 'description': 'Pittsburgh Sleep Quality Index (PSQI)'}, {'measure': 'Sleep', 'timeFrame': 'week 24', 'description': 'Pittsburgh Sleep Quality Index (PSQI)'}, {'measure': 'Physical activity', 'timeFrame': 'week 12', 'description': 'Motion sensor (activPAL3, Pal Technologies, Glasgow, Schottland)'}, {'measure': 'Physical activity', 'timeFrame': 'week 24', 'description': 'Motion sensor (activPAL3, Pal Technologies, Glasgow, Schottland)'}, {'measure': 'Fatigability', 'timeFrame': 'week 12', 'description': '30-Second Chair Stand Test'}, {'measure': 'Fatigability', 'timeFrame': 'week 24', 'description': '30-Second Chair Stand Test'}, {'measure': 'Adverse Events', 'timeFrame': 'week 12', 'description': 'Number of patients with adverse events'}, {'measure': 'Adverse Events', 'timeFrame': 'week 24', 'description': 'Number of patients with adverse events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hematologic Neoplasms', 'Supportive Therapy', 'Fatigue', 'Mind-body medicine', 'Complementary and alternative medicine'], 'conditions': ['Hematologic Neoplasms']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial aims to investigate the effectiveness of a mind-body group program as a supprtivemanagement strategy for fatigue in patients with malignant hematological diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with malignant hematological diseases in complete remission after primary chemotherapy and/or radiation\n* Physical and mental ability to attent 8 of 11 group units\n\nExclusion Criteria:\n\n* Chemotherapy, radiation, or rehabilitation programm during the study period\n* Pregnancy\n* Participation in other studies with behavioral interventions during the study period'}, 'identificationModule': {'nctId': 'NCT03735992', 'briefTitle': 'Mind-body Medicine for Patients With Malignant Hematological Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Universität Duisburg-Essen'}, 'officialTitle': 'Mind-body Medicine as a Supportive Strategy for Patients With Malignant Hematological Diseases: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'RBK02-17-00424'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mind-body medicine group program', 'description': 'Patients recieve an 11-week mind-body medicine group program including elements of mindfullness based stress reduction (MBSR), yoga, and education + treatment as usual.', 'interventionNames': ['Behavioral: Mind-body medicine group program']}, {'type': 'NO_INTERVENTION', 'label': 'Wait list', 'description': 'Treatment as usual.'}], 'interventions': [{'name': 'Mind-body medicine group program', 'type': 'BEHAVIORAL', 'description': 'The group program is mainly based on MBSR. It further integrates elements of the mind-body medicine cancer program of the Benson-Henry Mind/Body Medical Institute at Harvard Medical School which is rooted in psychoneuroendocrinology and focuses on relaxation techniques, exercise, cognitive restructuring, diet, and social support. In addition, naturopathic methods of selfregulation and self-care are incorporated.', 'armGroupLabels': ['Mind-body medicine group program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70376', 'city': 'Stuttgart', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Walter E. Aulitzky, Prof. MD', 'role': 'CONTACT', 'email': 'walter.aulitzky@rbk.de'}, {'name': 'Maria M. Winkler', 'role': 'CONTACT', 'email': 'marcela.winkler@rbk.de'}], 'facility': 'Robert-Bosch-Krankenhaus, Abteilung für Hämatologie, Onkologie und Palliativmedizin', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}], 'centralContacts': [{'name': 'Holger Cramer, PhD', 'role': 'CONTACT', 'email': 'holger.cramer@med.uni-tuebingen.de', 'phone': '+4971181017860'}, {'name': 'Heidemarie Haller, PhD', 'role': 'CONTACT', 'email': 'heidemarie.haller@uk-essen.de', 'phone': '+4920172377382'}], 'overallOfficials': [{'name': 'Gustav Dobos, Prof. MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universität Duisburg-Essen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Robert Bosch Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Director', 'investigatorFullName': 'Holger Cramer', 'investigatorAffiliation': 'Universität Duisburg-Essen'}}}}