Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-29 @ 4:55 PM
Study NCT ID:
NCT01035203
Status:
UNKNOWN
Last Update Posted:
2010-03-30
First Post:
2009-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Versus Cognitive Behavioural Therapy on Cancer-related Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2010-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-03-29', 'studyFirstSubmitDate': '2009-12-17', 'studyFirstSubmitQcDate': '2009-12-17', 'lastUpdatePostDateStruct': {'date': '2010-03-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue scores on the Brief Fatigue Inventory (BFI)', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Maximal oxygen uptake (VO2max) on a treadmill stress test.', 'timeFrame': '4 weeks'}, {'measure': 'Scores on the HADS (Hospital Anxiety and Depression Scale)', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Fatigue', 'Mood', 'Maximal Oxygen Uptake']}, 'descriptionModule': {'briefSummary': 'The investigators compare the effects of two interventions, an endurance exercise program and a cognitive behavioural therapy, on the fatigue, quality of life, mood and physical performance of patients with a cancer-related fatigue syndrome. The intervention will be carried out for 4 weeks. Tests will be carried out at the beginning and at the end of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-70\n* Histologically confirmed neoplastic disease\n* Treatment (chemotherapy or radiation) completed.\n* No treatment in the previous 4 weeks\n* Ability to understand written German\n\nExclusion Criteria:\n\n* Health conditions which can be aggravated by exercise'}, 'identificationModule': {'nctId': 'NCT01035203', 'briefTitle': 'Exercise Versus Cognitive Behavioural Therapy on Cancer-related Fatigue', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Effects of a Brief Endurance Exercise Program and of a Cognitive Behavioural Therapy on Patients With Cancer-related Fatigue', 'orgStudyIdInfo': {'id': '176-25/kmo'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive behavioural therapy', 'interventionNames': ['Behavioral: Cognitive behavioural therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise', 'description': 'Endurance training (walking on a treadmill) 3 x weekly for 4 weeks', 'interventionNames': ['Behavioral: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': 'Endurance exercise 3 times weekly for 45 minutes, 4 weeks long', 'armGroupLabels': ['Exercise']}, {'name': 'Cognitive behavioural therapy', 'type': 'BEHAVIORAL', 'description': 'Teaching of techniques to reduce fatigue and to improve stamina', 'armGroupLabels': ['Cognitive behavioural therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14167', 'city': 'Berlin', 'state': 'State of Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Fernando Dimeo, MD', 'role': 'CONTACT', 'email': 'fernando.dimeo@charite.de', 'phone': '+493084452098'}, {'name': 'Susanne Effenberger', 'role': 'CONTACT', 'email': 'susanne.effenberger@charite.de', 'phone': '+493084454834'}], 'facility': 'Department of Sports Medicine', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Fernando Dimeo, MD', 'role': 'CONTACT', 'email': 'fernando.dimeo@charite.de', 'phone': '+493084452098'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Fernando Dimeo, MD', 'oldOrganization': 'Charité Universitätsmedizin Berlin'}}}}