Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT01064427
Status:
UNKNOWN
Last Update Posted:
2010-02-08
First Post:
2010-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Factors Correlated With Fatigue in Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D005221', 'term': 'Fatigue'}], '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'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 557}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2012-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-02-05', 'studyFirstSubmitDate': '2010-02-05', 'studyFirstSubmitQcDate': '2010-02-05', 'lastUpdatePostDateStruct': {'date': '2010-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The Multidimensional Fatigue Inventory (MFI-20) questionnaire is used to assess patient's fatigue.", 'timeFrame': 'Breast cancer patients complete the questionnaires before surgery and at several times depending on their adjuvant treatment'}], 'secondaryOutcomes': [{'measure': 'Questionnaires regarding personality traits (LOT "Life Orientation Test" and the trait-version of the STAI "State Trait Anxiety instrument"), Quality of life questionnaire(EORTC QLQ-C30), and the state-version of the STAI will be also completed.', 'timeFrame': 'For the LOT and the trait-version of the STAI: only before the surgery, for the QLQ-C30: before surgery and several times during adjuvant treatment and for the state-version of the STAI: several times during adjuvant treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['breast cancer', 'fatigue', 'adjuvant chemotherapy', 'quality of life'], 'conditions': ['Newly Diagnosed Breast Cancer', 'Surgery Programmed']}, 'referencesModule': {'references': [{'pmid': '21078419', 'type': 'DERIVED', 'citation': 'Rotonda C, Guillemin F, Bonnetain F, Conroy T. Factors correlated with fatigue in breast cancer patients before, during and after adjuvant chemotherapy: the FATSEIN study. Contemp Clin Trials. 2011 Mar;32(2):244-9. doi: 10.1016/j.cct.2010.11.007. Epub 2010 Nov 13.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to identify the determinants of cancer-related fatigue, and the long-term effect of the different adjuvants treatments will be explored. A prospective longitudinal study in women diagnosed for the first time with stage I-III breast cancer and who have undergone surgery, has been designed to meet the study aims.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Recruitment began in September 2008 and is planned over a 24-month period. Participants with breast cancer are recruited from three French cancer centers, the Alexis Vautrin anti-cancer center of Vandoeuvre-les-Nancy, the Georges-François Leclerc anti-cancer center of Dijon and the Paul Strauss anti-cancer center of Strasbourg, France. Participation to study is proposed to all women with newly diagnosed breast cancer the day preceeding surgery.Included patients are asked to complete the questionnaires several times.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18 years and older\n* newly diagnosed with stage I-IIIA breast adenocarcinoma\n* have undergone surgery\n* WHO performance status score equal or lower than 2\n* able to provide informed consent\n* speak French and able to complete self-report questionnaires\n\nExclusion Criteria:\n\n* pregnancy\n* bilateral breast cancer\n* metastatic breast cancer\n* patients who received neoadjuvant chemotherapy\n* known psychiatric disease or dementia\n* no previous history of cancer'}, 'identificationModule': {'nctId': 'NCT01064427', 'acronym': 'FATSEIN', 'briefTitle': 'Factors Correlated With Fatigue in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Factors Correlated With Fatigue in Breast Cancer Patients Before, During and After Adjuvant Chemotherapy', 'orgStudyIdInfo': {'id': '08-FATQV'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chemotherapy group', 'description': 'Breast cancer patients treated by adjuvant chemotherapy after their surgery. The time points of data collection are before the start of the first, second, fourth and sixth cycle of chemotherapy. If patients are treated by radiotherapy after the chemotherapy, there are 2 measurements points pre- and post radiotherapy.The others measurement points are at 12,18 and 24 months after surgery.'}, {'label': 'No chemotherapy group', 'description': 'Breast cancer patients no treated by adjuvant chemotherapy after their surgery. For patients treated by radiotherapy after surgery, there are 2 measurement points pre- and post radiotherapy. The others measurement points are at 4,6,7,8,12,18 and 24 months after surgery.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '54 511', 'city': 'Vandœuvre-lès-Nancy', 'state': 'Meurthe et Moselle', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Rotonda Christine, PhD student', 'role': 'CONTACT', 'email': 'christine.rotonda@hotmail.fr', 'phone': '3 83 59 85 74', 'phoneExt': '+33'}, {'name': 'Conroy Thierry, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Alexis Vautrin', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': '21 000', 'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Rotonda Christine, PhD student', 'role': 'CONTACT', 'email': 'christine.rotonda@hotmail.fr', 'phone': '3 83 59 85 74', 'phoneExt': '+33'}, {'name': 'Bonnetain Franck', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Georges François Leclerc', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '67 000', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Rotonda Christine, PhD student', 'role': 'CONTACT', 'email': 'christine.rotonda@hotmail.fr', 'phone': '3 83 59 85 74', 'phoneExt': '+33'}, {'name': 'Velten Michel', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Paul Strauss', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Rotonda Christine, PhD student', 'role': 'CONTACT', 'email': 'christine.rotonda@hotmail.fr', 'phone': '3 83 59 85 74', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Guillemin Francis, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inserm, CIC-EC CIE6, Nancy; CHU Nancy'}, {'name': 'Conroy Thierry, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Alexis Vautrin, Department of Medical Oncology, Vandoeuvre-les-Nancy, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Francis Guillemin, PU-PH', 'oldOrganization': 'Inserm CIC-EC CIE6, CHU Nancy'}}}}