Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2026-02-13 @ 2:26 PM
Study NCT ID:
NCT04228432
Status:
COMPLETED
Last Update Posted:
2021-07-27
First Post:
2020-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
E-monitoring of Patients Under Adjuvant Hormonotherapy for 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-26', 'studyFirstSubmitDate': '2020-01-10', 'studyFirstSubmitQcDate': '2020-01-13', 'lastUpdatePostDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of patients who do not fail the E-Monitoring protocol', 'timeFrame': '6 months per patient'}], 'secondaryOutcomes': [{'measure': 'Number of medical consultations required over 6 months', 'timeFrame': '6 months per patient'}, {'measure': 'Rate of hormonotherapy adherence evaluated by the GIRERD questionnaire', 'timeFrame': '6 months per patient'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Hormonotherapy', 'E-monitoring'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a monocentric, prospective cohort study evaluating the feasibility of an E-monitoring protocol in patients with breast cancer treated by adjuvant hormonotherapy .\n\n45 patients will be included.\n\nPatients will be followed during 6 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient treated for hormone-dependent localized breast cancer with adjuvant HT (tamoxifen or anti-aromatase +/- LHRH agonist)\n2. Patient equipped with a computer or tablet computer and an internet connection at home\n3. Age \\> 18 years old\n4. Patient affiliated to the french social security system\n5. Patient who has signed informed consent before inclusion in the study and before any specific procedures for the study\n6. Women of childbearing age should have effective contraception under hormonotherapy\n\nExclusion Criteria:\n\n1. Patient with breast cancer who does not require adjuvant hormonotherapy\n2. Patient with metastatic breast cancer\n3. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure\n4. Patient previously treated for breast cancer (infiltrating or in-situ) with adjuvant HT or not\n5. Patient protected by law.'}, 'identificationModule': {'nctId': 'NCT04228432', 'acronym': 'EPOPEE', 'briefTitle': 'E-monitoring of Patients Under Adjuvant Hormonotherapy for Breast Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'Institut Claudius Regaud'}, 'officialTitle': 'E-monitoring of Patients Under Adjuvant Hormonotherapy for Breast Cancer: Pilot Study', 'orgStudyIdInfo': {'id': '19 SEIN 14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with breast cancer treated by adjuvant hormonotherapy', 'interventionNames': ['Other: Dedicated and coordinated monitoring']}], 'interventions': [{'name': 'Dedicated and coordinated monitoring', 'type': 'OTHER', 'description': '* Coordinated monitoring performed by a dedicated nurse: consultation before hormonotherapy initiation\n* Monitoring at home over a period of 6 months using an e-monitoring tool: assessment of adverse events and completion of GIRERD questionnaire at week 3 and week 6.', 'armGroupLabels': ['Patients with breast cancer treated by adjuvant hormonotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toulouse', 'country': 'France', 'facility': 'Institut Universitaire du Cancer Toulouse Oncopole', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Claudius Regaud', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}