Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 12:42 AM
Study NCT ID:
NCT06583460
Status:
RECRUITING
Last Update Posted:
2025-08-05
First Post:
2024-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Systematic Intervention to Improve Sexual Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Category 2 clinical trial, monocentric, prospective, comparative, controlled but not randomized'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-06-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2024-08-06', 'studyFirstSubmitQcDate': '2024-09-02', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sexual satisfaction', 'timeFrame': 'Measured at baseline and at 18 months following initiation of treatment and surgical.', 'description': 'Sexual satisfaction score measured by self-questionnaire using the EORTC Quality of Life Questionnaire Sexual Health scale (EORTC QLQ-SH22).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sexual dysfunction'], 'conditions': ['Breast Cancer Female', 'Localized Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this clinical trial is to compare the benefit of early, systematic, multidisciplinary oncosexological care versus on-demand care on the sexual health of women with breast cancer.', 'detailedDescription': 'The aim of the study is to evaluate the effectiveness of early, systematized oncosexology care on perceived sexual health at 18 months, compared with oncosexology care on demand.\n\nAll included patients are evaluated at Baseline and M18 following initiation of antineoplastic treatments associated with surgery. Patients who accepted additional oncosexological care were also assessed at M4, M8 and M12. The content of support care is detailed in section "arms and interventions".\n\nOncosexology consultations with the sexologist and the medical support care of any organic disorders remain accessible to all patients, on request, including the group of patients who do not wish to participate in early and systematic oncosexology care.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women ≥ 18 years (menopausal or not),\n* Localized breast cancer with or without lymph node involvement,\n* Initial treatment starting with surgical resection, whatever the associated therapy (chemotherapy, radiotherapy, hormone therapy, monoclonal antibody, conjugated drug antibody, targeted therapy such as cyclin and anti-PARP inhibitors, etc.),\n* Patient affiliated or benefiting from the social security system,\n* Patient informed and informed consent signed.\n\nExclusion Criteria:\n\n* History of cancer (except squamous cell carcinoma or basal cell carcinoma) in the last five years,\n* Pregnant or breast-feeding women,\n* Patients deprived of their liberty, under guardianship or curatorship and all other administrative safeguards,\n* Patients unable to comply with the study schedule for social, medical or psychological reasons.'}, 'identificationModule': {'nctId': 'NCT06583460', 'acronym': 'SISTER', 'briefTitle': 'Systematic Intervention to Improve Sexual Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Center Eugene Marquis'}, 'officialTitle': 'Systematic Intervention to Improve Sexual Dysfunction in Adjuvant Breast Cancer Patients', 'orgStudyIdInfo': {'id': '2023-4-72-002'}, 'secondaryIdInfos': [{'id': '2023-A02035-40', 'type': 'REGISTRY', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Breast cancer treatment with oncosexology supporting care', 'description': 'Patient initially treated by surgery combined with any therapy (chemotherapy, radiotherapy, hormonal therapy etc.) and benefiting oncosexological care.', 'interventionNames': ['Other: Early and systematic oncosexological supporting care']}], 'interventions': [{'name': 'Early and systematic oncosexological supporting care', 'type': 'OTHER', 'description': 'Each patient included in the study will be cared by an anthropologist and a sexologist.\n\nThis therapeutic support care will be based on :\n\n* 2 qualitative semi-directive interviews (Baseline and M18),\n* 2 individual consultations with questionnaires (Baseline and M18).\n\nThe qualitative semi-structured interviews will be conducted with the anthropologist, and the individual consultations with the sexologist.\n\nAt the end of the first oncosexology consultation, patients will be given the opportunity to decide whether or not to accept further systematic oncosexology support care, which will be based on :\n\n* 3 individual and/or couple consultations,\n* 3 group workshops.\n\nPatients are under no obligation to accept this additional oncosexology support care.', 'armGroupLabels': ['Breast cancer treatment with oncosexology supporting care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35042', 'city': 'Rennes', 'state': 'Brittany Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marion Trochet', 'role': 'CONTACT', 'email': 'm.trochet@rennes.unicancer.fr', 'phone': '02 99 25 31 65', 'phoneExt': '+33'}, {'name': 'Valérie Jolaine', 'role': 'CONTACT', 'email': 'v.jolaine@rennes.unicancer.fr', 'phone': '02 99 25 30 36', 'phoneExt': '+33'}, {'name': 'Claudia Lefeuvre-Plesse, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre de Lutte contre le Cancer Eugène Marquis', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'centralContacts': [{'name': 'Marion Trochet', 'role': 'CONTACT', 'email': 'm.trochet@rennes.unicancer.fr', 'phone': '0299253165', 'phoneExt': '+33'}, {'name': 'Valérie Jolaine', 'role': 'CONTACT', 'email': 'v.jolaine@rennes.unicancer.fr', 'phone': '0299253036', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Claudia Lefeuvre-Plesse, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre de Lutte Contre Le cancer Eugène Marquis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center Eugene Marquis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}