Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-30 @ 1:47 PM
Study NCT ID:
NCT04038606
Status:
UNKNOWN
Last Update Posted:
2019-07-31
First Post:
2016-09-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SEINIOR:Quality of Life and Breast Cancer in Older Women
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants completed a questionnaires that included the test sociodemographic characteristics and a number of standardized validated instruments translated in French language designed to assess for quality of life and psychological profile.\n\nParticipants will undergo blood test, electrocardiogram, blood pressure monitoring, geriatric standard evaluation.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 174}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2020-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-27', 'studyFirstSubmitDate': '2016-09-28', 'studyFirstSubmitQcDate': '2019-07-27', 'lastUpdatePostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of quality of life change by SF-36 (The Short Form Health Survey) between baseline and six months', 'timeFrame': 'Baseline and 6 months', 'description': 'the 36-Item Short Form Health Survey (SF-36). SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized monitoring and assessment of care outcomes in adult patients.\n\na score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability'}], 'secondaryOutcomes': [{'measure': 'QLQ-C30 (Global Health Status)', 'timeFrame': 'Baseline and 6 months', 'description': "Quality of life (QoL or QOL) is the perceived quality of an individual's daily life, that is, an assessment of their well-being or lack thereof. This includes all emotional, social and physical aspects of the individual's life;All of the scales and single-item measures range in score from 0 to 100."}, {'measure': 'Psychological profile', 'timeFrame': 'Baseline and 6 months', 'description': 'Big Five Inventory (BFI),personality inventory for research settings, minimum = 45 points and maximum scores = 180 points .'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Background :\n\nBreast cancer is a disease that occurs primarily in elderly women: 54057 of breast cancer occurred on women in 2008, 15.2% were between 75 and 84 years and 5.4% were over 85 years. Elderly women cancers care exposes to several problems: the opportunity for screening, knowing that mammography is not recommended after 75 years old, and the level of treatment depending on the background and the existence of weaknesses. It should determine whether patients are in adequate physiological condition to tolerate classical and "complete" treatment or conversely in a precarious state with advanced fragility, justifying only lightened and adapted symptomatic treatment.\n\nPurpose :\n\nThe purpose of this research theme is to assess the quality of life of elderly patients who underwent mastectomy for breast cancer. The objectives are:\n\n* Assess the determinants of acceptance and / or rejection of mastectomy based on personal background (level of fragility, self-image) and linked to cancer\n* Assess the quality of life, 6 months later, of women who underwent or not mastectomy, and appreciate the determinants\n\nAbstract :\n\nThe total mastectomy allow, oncologically, a more valid treatment than a lumpectomy, in many cases of women suffering from a breast cancer, but its relevance and acceptability are poorly known. Some think that an elderly woman, postmenopausal, is less concerned with her aesthetics and feminine attributes, which would allow her to accept easily the mastectomy.\n\nThe research hypothesis is that the acceptability of mastectomy is not good in elderly women', 'detailedDescription': 'Primary outcome:\n\nBetter detection of comorbidity and geriatric syndromes in vulnerable patients Better detection of a degradation of the quality of life at D0 (at diagnosis)\n\nSecondary outcomes:\n\nBetter support for quality of life and psychological support after mastectomy (revaluation to 6 months) Integration of patients in the geriatric sector and implementation of regular monitoring Study design: prospective, multicenter'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Elderly patients about or over 75 years\n2. Female\n3. Patients in whom a diagnosis of breast cancer with surgical indication for mastectomy with or without lymph node dissection is discussed\n4. Ability to understand and give freely consent\n5. Informed consent signed\n6. Patient affiliated to the social security or entitled\n\nExclusion Criteria:\n\n1. Patients under 75 years\n2. Male\n3. Patients under legal protection'}, 'identificationModule': {'nctId': 'NCT04038606', 'acronym': 'SEINIOR', 'briefTitle': 'SEINIOR:Quality of Life and Breast Cancer in Older Women', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Central Hospital Saint Quentin'}, 'officialTitle': 'Quality of Life and Breast Cancer in Older Women', 'orgStudyIdInfo': {'id': '2016-A00286-45'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'acceptance of mastectomy', 'description': 'Assess the determinants of acceptance of mastectomy based on personal background,Measured by questionnaires: self-image (Rosenberg),personal background (level of fragility, self-image),quality of life SF-36, QLQC30,pain (BPI-SF) and Big Five Inventory.', 'interventionNames': ['Other: Determination of acceptance and / or rejection of mastectomy']}, {'type': 'EXPERIMENTAL', 'label': 'rejection of mastectomy', 'description': 'Assess the determinants of rejection of mastectomy based on personal background, Measured by questionnaires: self-image (Rosenberg),personal background (level of fragility, self-image),quality of life SF-36, QLQC30,pain (BPI-SF) and Big Five Inventory.', 'interventionNames': ['Other: Determination of acceptance and / or rejection of mastectomy']}], 'interventions': [{'name': 'Determination of acceptance and / or rejection of mastectomy', 'type': 'OTHER', 'description': 'Blood exams,Participants completed a questionnaire translated in French language : Rosenberg,SF-36, QLQC30, Big Five Inventory,BPI-SF.:-)', 'armGroupLabels': ['acceptance of mastectomy', 'rejection of mastectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02100', 'city': 'Saint-Quentin', 'state': 'Aisne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'ATTIER Dr Jadwiga, PI', 'role': 'CONTACT'}], 'facility': 'Centre Hospitalier de Saint-Quentin;', 'geoPoint': {'lat': 49.84889, 'lon': 3.28757}}], 'centralContacts': [{'name': 'ATTIER-ZMUDKA Dr Jadwiga, IC', 'role': 'CONTACT', 'email': 'J.ATTIER@ch-stquentin.fr', 'phone': '00333 23 06 72 16'}, {'name': 'BOULANOUAR M Abdelkrim, CRA', 'role': 'CONTACT', 'email': 'AK.BOULANOUAR@ch-stquentin.fr', 'phone': '0033323067861'}], 'overallOfficials': [{'name': 'ATTIER-ZMUDKA Dr Jadwiga, PI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint Quentin Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Participants completed a questionnaire that included the test sociodemographic characteristics and a number of standardized validated instruments translated in French language designed to assess for quality of life and psychological profile.\n\nParticipants will undergo blood test, electrocardiogram, blood pressure monitoring, geriatric standard evaluation.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital Saint Quentin', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}