Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT03408769
Status:
COMPLETED
Last Update Posted:
2018-08-08
First Post:
2018-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metastatic Breast Carcinoma and Women Sexual Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D019529', 'term': 'Sexuality'}, {'id': 'C563016', 'term': 'pseudofolliculitis barbae'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-07', 'studyFirstSubmitDate': '2018-01-18', 'studyFirstSubmitQcDate': '2018-01-18', 'lastUpdatePostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of sexual life of postmenopausal women with metastatic breast carcinoma living in couples', 'timeFrame': '1 day', 'description': 'Quality of sexual life will assessed by BISF-W (Brief index of sexual functioning for women) questionnaire'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '1 day', 'description': 'Quality of life will assessed by quality of life breast cancer module questionnaire (QLQ-BR23) (Hinz et al, 2014)'}, {'measure': 'Quality of Relationship of the couple', 'timeFrame': '1 day', 'description': 'Quality of Relationship of the couple will assessed by partnership questionnaire (PFB). 30 items making up a global scale measuring the Quality of relationship (PFB).Quality of relationship (PFB) score can be obtained with the following equation: PFB = (30 - Quarreling) + Tenderness + Togetherness/communication ( Rossier et al, 2006).'}, {'measure': 'Sexual and emotional intimacy', 'timeFrame': '1 day', 'description': 'Patients will be interviewed by open-ended questions face to face concerning their Sexual and emotional intimacy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer', 'Sexuality', 'Quality of life', 'Intimacy', 'BISF-WBrief Index of Sexual Functioning for Women questionnaire', 'Quality of life questionnaire (EORTC QLQ-BR23):', 'Partnership questionnaire (partnerschaftsfragebogen; PFB)'], 'conditions': ['Metastatic Breast Carcinoma']}, 'descriptionModule': {'briefSummary': 'Sexual health is one of the relevant parameters for assesing the quality of life.\n\nImprovement sexual and emotional function improves quality of life scores and depression or anxiety in curative phase.\n\nThe purpose of the study is to assess the quality of sexual life of postmenopausal women with metastatic breast cancer in couples and to establish links with overall quality of life and the quality of the relationship.', 'detailedDescription': 'We use a quantitative methodology to assess quality of female sexual life, quality of life and quality o relationship with validated scientific questionnaires.\n\nThe sexual and emotional intimacy will be explored by semi structured interview, not mandatory for patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will be offered to women aged 50 to 70, with metastatic breast carcinoma and living in a couple and followed at the Lorraine Institute of Oncology.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with metastatic breast cancer\n* Age ≥ 50 and \\< 70 years old\n* Diagnosis of metastatic breast cancer at least 6 months prior to study participation\n* Patient living with a partner\n* Menopausal women (absence of menstruation for 1 year minimum)\n* ECOG performance status ≤ 2\n* Affiliated to public health system\n* Informed and having expressed her non-opposition\n\nExclusion Criteria:\n\n* Patient in exclusive palliative care\n* Single or not living in a couple\n* Non-menopausal patient'}, 'identificationModule': {'nctId': 'NCT03408769', 'acronym': 'SexoMBC', 'briefTitle': 'Metastatic Breast Carcinoma and Women Sexual Quality of Life', 'organization': {'class': 'OTHER', 'fullName': 'Institut de Cancérologie de Lorraine'}, 'officialTitle': 'Metastatic Breast Carcinoma: Evaluation of Women Sexual Quality of Life', 'orgStudyIdInfo': {'id': '2017-A03413-50'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Medical questionnaire', 'type': 'OTHER', 'description': '* Brief Index of Sexual Functioning for Women questionnaire\n* Quality of life questionnaire (EORTC QLQ-BR23)\n* Partnership questionnaire (partnerschaftsfragebogen; PFB)\n* Short interview about their sexual intimacy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Institut de Cancérologie de Lorraine', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'overallOfficials': [{'name': 'Dubuc Myriam', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut de Cancérologie de Lorraine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de Cancérologie de Lorraine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}