Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2026-01-11 @ 7:27 AM
Study NCT ID:
NCT03604666
Status:
UNKNOWN
Last Update Posted:
2019-01-23
First Post:
2018-06-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow-up of Elderly Patients in Ambulatory Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D012878', 'term': 'Skin 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-18', 'studyFirstSubmitDate': '2018-06-10', 'studyFirstSubmitQcDate': '2018-07-20', 'lastUpdatePostDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients operated on an outpatient basis', 'timeFrame': '3 month', 'description': 'Test the impact of an oncology ambulatory surgical care in patients aged 75 years or older, with breast or skin cancer and treated in Henri Mondor hospital'}], 'secondaryOutcomes': [{'measure': 'Number of death', 'timeFrame': 'at Day 30 and Day 90', 'description': 'Test the impact of the new organization of care on the mortality'}, {'measure': 'Number of patients converted to conventional care', 'timeFrame': 'at Day 30 and Day 90', 'description': 'Test the impact of the new organization of care on the proportion of patients converted to conventional care'}, {'measure': 'Number of the passage to emergencies', 'timeFrame': 'at Day 30 and Day 90', 'description': 'Test the impact of the new organization of care on the passage to emergencies'}, {'measure': 'Number of not programmed hospitalizations', 'timeFrame': 'at Day 30 and Day 90', 'description': 'Test the impact of the new organization of care on the not programmed hospitalizations'}, {'measure': 'The autonomy Activities of Daily Living (ADL)', 'timeFrame': 'at Day 30 and Day 90', 'description': 'Test the impact of the new organization of care on the autonomy (ADL/IADL)'}, {'measure': 'The autonomy Instrumental Activities of Daily Living (IADL)', 'timeFrame': 'at Day 30 and Day 90', 'description': 'Test the impact of the new organization of care on the autonomy (ADL/IADL)'}, {'measure': 'Number of institutionalization to Long-term care and skilled nursing facilities', 'timeFrame': 'at Day 30 and Day 90', 'description': 'Test the impact of the new organization of care on the institutionalization to Long-term care and skilled nursing facilities'}, {'measure': 'Number of passage to Long-term care and skilled nursing facilities', 'timeFrame': 'at Day 30 and Day 90', 'description': 'Test the impact of the new organization of care on the passage to Long-term care and skilled nursing facilities'}, {'measure': 'Number of postoperative complications', 'timeFrame': 'at Day 90', 'description': 'Test the impact of the new organization of care on the postoperative complications'}, {'measure': 'Costs of care', 'timeFrame': 'at Day 30 and Day 90', 'description': 'Test the impact of the new organization of care on the costs of care'}, {'measure': "Patients' satisfaction (questionnaire) for the prospective part of the study", 'timeFrame': 'at Day 30 and Day 90', 'description': "Test the impact of the new organization of care on patients' satisfaction"}, {'measure': "Patient's quality of life (EQ50 questionnaire, for the prospective part of the study)", 'timeFrame': 'at Day 30 and Day 90', 'description': 'Test the impact of the new organization of care on quality of life (EQ50) (for the prospective part of the study)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Skin cancer', 'Surgery', 'Ambulatory'], 'conditions': ['Breast Cancer', 'Skin Cancer', 'Surgery', 'Ambulatory']}, 'descriptionModule': {'briefSummary': 'The number of surgical procedures performed in ambulatory hospitalization for cancers of the skin or breast is increasing for medical and economic reasons. But the protocols of care and the clinical pathways are poorly adapted for elderly patients with physical or cognitive impairment.\n\nThe goal of this study is to test the impact of an oncology ambulatory surgical care in patients aged 75 years or older, with breast or skin cancer and treated in Henri Mondor hospital on the increase in the proportion of patients operated on an outpatient basis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients over 75 years consulting at the dermatological crossroads or "crossroads breast" and requiring surgery for a cancer of the skin or breast (without reconstruction)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient ≥ 75 years old with breast cancer or skin cancer and requiring surgical excision: partial mastectomy, lumpectomy, axillary dissection, cutaneous excision, etc.\n* With an indication of ambulatory care\n* Patient (legal representative or trusted person or member of the family) having been informed and having given his non-oral objection to his participation in the study\n* Possessing a health insurance\n\nExclusion Criteria:\n\n* Patients reserved for breast reconstruction to the operative gesture of tumor resection.\n* Patients do not consent to care because of deficient mental state.\n* Formal surgical contraindication due to a pathology medical device does not allow anesthesia. - Participation in another interventional research or be in the exclusion period after a previous search, if applicable'}, 'identificationModule': {'nctId': 'NCT03604666', 'acronym': 'PAPA', 'briefTitle': 'Follow-up of Elderly Patients in Ambulatory Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Ambulatory Process of Elderly Patient for Skin and Breast Cancer Surgery', 'orgStudyIdInfo': {'id': 'K170702J'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Health care process with Nurse Navigator', 'description': 'A Nurse Navigator will:\n\n* Be present at the announcement consultation\n* Give information on the outpatient circuit\n* Offer assistance for patients over 75 years\n* Complete onco-geriatric orientation questionnaires\n* Take care of patients on the ambulatory circuit', 'interventionNames': ['Other: Health care process with Nurse Navigator']}, {'label': 'Health care process', 'description': 'Health care process'}], 'interventions': [{'name': 'Health care process with Nurse Navigator', 'type': 'OTHER', 'description': 'A Nurse Navigator will:\n\n* Be present at the announcement consultation\n* Give information on the outpatient circuit\n* Offer assistance for patients over 75 years\n* Complete onco-geriatric orientation questionnaires\n* Take care of patients on the ambulatory circuit', 'armGroupLabels': ['Health care process with Nurse Navigator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94000', 'city': 'Créteil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Romain Bosc, MD', 'role': 'CONTACT', 'email': 'romainbosc@gmail.com', 'phone': '01.49.81.25.33', 'phoneExt': '+33'}, {'name': 'laetitia Gregoire', 'role': 'CONTACT', 'email': 'laetitia.gregoire@aphp.fr', 'phone': '01.49.81.41.64', 'phoneExt': '+33'}], 'facility': 'Bosc', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}], 'centralContacts': [{'name': 'Romain BOSC, MD', 'role': 'CONTACT', 'email': 'romain.bosc@aphp.fr', 'phone': '0149812533', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Romain BOSC, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}