Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-31 @ 11:43 PM
Study NCT ID:
NCT01013233
Status:
UNKNOWN
Last Update Posted:
2009-11-13
First Post:
2009-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Training to Improve Cognitive Function Following Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000091942', 'term': 'Cognitive Training'}, {'id': 'D012681', 'term': 'Sensitivity Training Groups'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011615', 'term': 'Psychotherapy, Group'}, {'id': 'D012960', 'term': 'Socioenvironmental Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2011-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-11-12', 'studyFirstSubmitDate': '2009-11-12', 'studyFirstSubmitQcDate': '2009-11-12', 'lastUpdatePostDateStruct': {'date': '2009-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'several cognitive tests (TAP, VLMT, TMT, Stroop, RWT, D2, LGT-3)', 'timeFrame': 'one weeks following the end of the cognitive training'}], 'secondaryOutcomes': [{'measure': 'quality of life and subjective perception of cognitive problems', 'timeFrame': '7 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cognitive dysfunction chemotherapy'], 'conditions': ['Cognitive Dysfunction']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to improve cognitive dysfunction following chemotherapy, the investigators investigated to see whether a cognitive training for memory and concentration skills can improve cognitive performance in patients following cancer treatment.', 'detailedDescription': 'Patients following chemotherapy invited for a cognitive training. Before and after cognitive function will evaluate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with cancer 6 weeks after chemotherapy\n\nExclusion Criteria:\n\n* patients with neurological or psychiatric disorders\n* patients without compliance'}, 'identificationModule': {'nctId': 'NCT01013233', 'acronym': 'KT', 'briefTitle': 'Cognitive Training to Improve Cognitive Function Following Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Training of Cognitive Function of Patients After Chemotherapy', 'orgStudyIdInfo': {'id': 'KTST09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'training', 'description': 'Patients in this group start the cognitive training over 6 weeks directly after randomization.', 'interventionNames': ['Behavioral: cognitive training']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'In this control group begin the training in a cross-over design 7 weeks after randomization.', 'interventionNames': ['Other: control group']}], 'interventions': [{'name': 'cognitive training', 'type': 'BEHAVIORAL', 'otherNames': ['training group'], 'description': 'cognitive training over 6 weeks, consist of 6 meetings (a 45minutes), three sessions focus on concentration tasks and three sessions on memory problems.', 'armGroupLabels': ['training']}, {'name': 'control group', 'type': 'OTHER', 'otherNames': ['controll group'], 'description': 'no intervention', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12200', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'contacts': [{'name': 'Susanne Effenberger, MSc', 'role': 'CONTACT', 'email': 'susanne.effenberger@charite.de', 'phone': '+49-30-8445-2410'}, {'name': 'susanne Effenberger, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Charite Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Susanne Effenberger, MSc', 'role': 'CONTACT', 'email': 'susanne.effenberger@charite.de', 'phone': '+49-30-8445-2410'}, {'name': 'Fernando Dimeo, MD', 'role': 'CONTACT', 'email': 'fernando.dimeo@charite.de', 'phone': '+49-30-8445-4834'}], 'overallOfficials': [{'name': 'Michael Niedeggen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Freie Universität Berlin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'Freie Universität Berlin', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Fernando Dimeo', 'oldOrganization': 'Charite University, Berlin, Germany'}}}}