Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2025-12-26 @ 6:34 AM
Study NCT ID:
NCT03103659
Status:
UNKNOWN
Last Update Posted:
2017-04-06
First Post:
2017-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimization and Improvement of Care Course for 75 Years and Over Patient With Cancer and Living in Nursing Home on the Marseille Agglomeration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-04-27', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2019-04-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-05', 'studyFirstSubmitDate': '2017-03-31', 'studyFirstSubmitQcDate': '2017-04-05', 'lastUpdatePostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time frame between diagnosis and access to oncologies care facilities', 'timeFrame': '6 months', 'description': 'Number of days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer', 'Elderly']}, 'referencesModule': {'references': [{'pmid': '33392770', 'type': 'DERIVED', 'citation': 'Couderc AL, Berbis J, Delalande G, Mugnier B, Courcier A, Bourriquen M, Rey D, Greillier L, Baciuchka M, Sudour P, Agnelli L, Nouguerede E, Fabries S, Villani P. Impact of care pathway for nursing home residents treated for cancer: ONCO-EHPAD study. Support Care Cancer. 2021 Jul;29(7):3933-3942. doi: 10.1007/s00520-020-05973-1. Epub 2021 Jan 3.'}]}, 'descriptionModule': {'briefSummary': 'According to data from the French National Cancer Institute (INCA), almost one third of the cancers were diagnosed in overs 75 years patients in France in 2008. The elderly patients management is an important part in oncology daily practice.\n\nThese last years, through the geriatric oncology development, collaboration between oncologists and geriatricians, the anti-cancer management and supportive care for elderly patients has evolved. The assessement of potential fragility helps to determine the cancers appropriate treatment plan.\n\nStudies have shown that alterations in geriatric fields, found through Comprehensive Geriatric Assessment (CGA) are associated with poorer survival, increased risk of chemotherapy severe toxicity and autonomy loss.\n\nNursing home residents have often more frailties and functional problems than living at home elderly resulting in diagnostic and therapeutic cancer delay. In addition, nursing home residents must have appropriate treatment to preserve as much as possible their quality of life.\n\nTransversal Onco-Geriatrics Unit (UTOG), Day Hospital (HDJ), External Geriatric Mobile Unit (EMGE) of the Internal Medicine, Geriatric and Therapeutic Department of the Marseille hospital propose to organize a personalized care course for nursing home residents with cancer to minimize the diagnostics delay, facilitate their management in oncology and maintain their quality of life.\n\nElderly patient with suspected cancer is oriented by EMGE to HDJ to realize an oncological and geriatric assessment. Patient would be supported by UTOG and would have access to technical platform.\n\nAccording to his cancer and nursing home location, the nearest reference center would be offered.\n\nTreatment or course of action (monitoring, palliative care …) would be decided in onco-geriatric multidisciplinary meeting (RCP) (organized by Onco-Geriatric Coordination Unit UCOG PACA west) and programmed and fast hospitalization would be organized in the reference center.\n\nWhen returning in nursing homes, elderly patient would be revalued by EMGE to continue therapeutic management and personalized care plan. The aim of this management is to allow a shorter hospitalization and maintain the quality of life of frailty patient during cancer treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elderly patients with new diagnosis of cancer or follow-up breakdown or progression of the cancer disease\n\nExclusion Criteria:\n\n* Elderly patients with cognitive impairment.'}, 'identificationModule': {'nctId': 'NCT03103659', 'acronym': 'ONCO-EHPAD', 'briefTitle': 'Optimization and Improvement of Care Course for 75 Years and Over Patient With Cancer and Living in Nursing Home on the Marseille Agglomeration', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Optimization and Improvement of Care Course for 75 Years and Over Patient With Cancer and Living in Nursing Home on the Marseille Agglomeration', 'orgStudyIdInfo': {'id': '2016-48'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Elderly patient with cancer living in a nursing home', 'interventionNames': ['Other: personalised care plan']}], 'interventions': [{'name': 'personalised care plan', 'type': 'OTHER', 'description': 'Quality of life assessement in elderly cancer patients', 'armGroupLabels': ['Elderly patient with cancer living in a nursing home']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13354', 'city': 'Marseille', 'country': 'France', 'contacts': [{'name': 'Anne-Laure COUDERC, MD', 'role': 'CONTACT'}], 'facility': 'Assistance Publique Hôpitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'Anne-Laure COUDERC, MD', 'role': 'CONTACT', 'email': 'anne-laure.couderc@ap-hm.fr'}], 'overallOfficials': [{'name': 'Urielle DESALBRES', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique Hôpitaux de Marseille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}