Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-30 @ 3:11 AM
Study NCT ID:
NCT01458457
Status:
COMPLETED
Last Update Posted:
2015-02-16
First Post:
2011-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Life Quality and Mental State in Patients With Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 275}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-13', 'studyFirstSubmitDate': '2011-10-21', 'studyFirstSubmitQcDate': '2011-10-21', 'lastUpdatePostDateStruct': {'date': '2015-02-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Functional Assessment of Cancer Therapy-Breast quality of life instrument (FACT-B)', 'timeFrame': '3 months'}, {'measure': 'Subscales of the Functional Assessment of Cancer Therapy - General (FACT-G): physical well-being, social/family well-being, emotional well-being, functional well-being)', 'timeFrame': '3, 6 months'}, {'measure': 'Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)', 'timeFrame': '3, 6 months'}, {'measure': 'Pain, quality of sleep, and nausea (single items of the FACT-B)', 'timeFrame': '3, 6 months'}, {'measure': 'Functional Assessment of Chronic Illness Therapy-Fatigue', 'timeFrame': '3, 6 months'}, {'measure': 'Survival without relapse', 'timeFrame': '6 months'}, {'measure': 'Quality of Life (SF-12 Health Survey)', 'timeFrame': '3, 6 months'}, {'measure': 'Undesirable Effects and Interactions', 'timeFrame': '6 months'}, {'measure': 'Goal Attainment Scale', 'timeFrame': '3 months', 'description': 'This outcome measures will only be assessed in the complementary medicine arm'}, {'measure': 'Used complementary Therapies and their frequency', 'timeFrame': '6 months', 'description': 'This will only be assessed in the complementary medicine arm'}, {'measure': 'Expectations at Baseline', 'timeFrame': 'Baseline', 'description': 'This will only be assessed in the complementary medicine group'}, {'measure': 'Satisfaction and patient-reported effectiveness', 'timeFrame': '3, 6 months', 'description': 'This will only be assessed in the complementary medicine arm'}, {'measure': 'Survival', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '25555830', 'type': 'RESULT', 'citation': 'Witt CM, Ausserer O, Baier S, Heidegger H, Icke K, Mayr O, Mitterer M, Roll S, Spizzo G, Scherer A, Thuile C, Wieser A, Schutzler L. Effectiveness of an additional individualized multi-component complementary medicine treatment on health-related quality of life in breast cancer patients: a pragmatic randomized trial. Breast Cancer Res Treat. 2015 Jan;149(2):449-60. doi: 10.1007/s10549-014-3249-3. Epub 2015 Jan 3.'}]}, 'descriptionModule': {'briefSummary': 'Randomized pragmatic trial to evaluate the comparative effectiveness regarding disease specific quality of life of an individualized additional complementary medicine treatment in addition to usual care with usual care only in 280 women with breast cancer'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed breast cancer\n* current usual care treatment\n* willing to refrain from complementary treatment for 6 months in case of randomization into the usual care group\n* informed consent\n\nExclusion Criteria:\n\n* complementary treatment at the Hospital Meran in the last 6 months\n* no German or Italian language ability\n* participation in other study'}, 'identificationModule': {'nctId': 'NCT01458457', 'acronym': 'BBK', 'briefTitle': 'Life Quality and Mental State in Patients With Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Life Quality and Mental State in Patients With Breast Cancer - a Randomized Study', 'orgStudyIdInfo': {'id': 'BBK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'interventionNames': ['Other: Individualized usual care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care + Complementary Medicine', 'interventionNames': ['Other: Individualized complementary medicine treatment', 'Other: Individualized usual care']}], 'interventions': [{'name': 'Individualized complementary medicine treatment', 'type': 'OTHER', 'description': 'An individual treatment plan will be made for each patient that includes one to all of the following treatments: acupuncture, traditional Chinese herbal medicine, enzyme therapy, nutrition advise, Healing Touch, homoeopathy, hyperthermia treatment, infusions, laser therapy, lymphatic drainage, manual therapy, mistel therapy, neural therapy, orthomolecular therapy, osteopathy, phytotherapy, shiatsu', 'armGroupLabels': ['Usual Care + Complementary Medicine']}, {'name': 'Individualized usual care', 'type': 'OTHER', 'description': 'Patients get usual care from their general practitioners/specialized physicians', 'armGroupLabels': ['Usual Care + Complementary Medicine', 'Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39012', 'city': 'Meran', 'country': 'Italy', 'facility': 'Meran Hospital - Dienst fuer Komplementaermedizin', 'geoPoint': {'lat': 45.71012, 'lon': 7.66705}}], 'overallOfficials': [{'name': 'Claudia M Witt, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda Sanitaria de Sudtirol, Hospital Meran, Meran, Italy', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Claudia M. Witt', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}