Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT02873533
Status:
COMPLETED
Last Update Posted:
2025-09-30
First Post:
2016-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Modification of the Quality of Life Based on Objective Geriatric Tests
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': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2016-08-11', 'studyFirstSubmitQcDate': '2016-08-18', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measuring quality of life according to geriatric questionnaires', 'timeFrame': '36 months', 'description': 'Activities of Daily Living Questionnaire'}], 'secondaryOutcomes': [{'measure': 'Geriatric Screening Test fragilities and comorbidities', 'timeFrame': '36 months', 'description': 'Mini Mental State Examination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cancer', 'Elderly Patients']}, 'descriptionModule': {'briefSummary': 'The analysis of this study will achieve an improvement in the management of patients over 70 years with adaptation of chemotherapy regimens after analysis of the subject and its psychosocial environment.\n\nThe analysis of socio-economic impacts will implement actions to optimize the care of the elderly while emphasizing the value of management / cost of care.', 'detailedDescription': 'Quality of life is defined as "an individual\'s perception of his place in life, in the context of culture and value system in which he lives, in relation to its goals, expectations, standards and concerns "(WHO 1993).\n\nThis concept refers to multiple dimensions, both objective and subjective:\n\n* The physical condition of the person, his functional abilities;\n* His somatic sensations;\n* His psychological health;\n* His social status, relational environment.\n\nThis concept focuses on perception\'s basics. Quality of life is a criteria supposed to be objective even though it is subject to subjective interpretation at the highest point. Indeed, if the quality of life varies depending on the discretion of each person, it also changes over time: it refers to a situation at a given moment and not to a stable state.\n\nTherefore in this study, it seemed appropriate to show the concept of "quality of life objective" which is linked to objective data measures recognized criteria for evaluating the elderly. These criteria are repeatable, validated and not dependent operator.\n\nThis process completely matches with the actions promoted by the 2009-2013 Cancer Plan (measures 23 and 26) on the basis of an improvement of:\n\n* The quality of consideration of the psychosocial dimension (customization accompaniment, living environment, social, involvement, ..)\n* The quality of the integration of physical and psychological dangers inherent to this weakness situation induced by cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient over 70 years,\n* Patient with a solid malignant tumor,\n* Patients for whom a first line chemotherapy is theoretically indicated\n* Patient chemotherapy naive,\n* Performance Index (PS) \\<4\n\nExclusion Criteria:\n\n* Patient not understanding or do not speak French,\n* Patients with any severe psychopathological disorder preventing the completion of the questionnaire or invalidating a priori measures of the questionnaire'}, 'identificationModule': {'nctId': 'NCT02873533', 'acronym': 'MEGERIA', 'briefTitle': 'Modification of the Quality of Life Based on Objective Geriatric Tests', 'organization': {'class': 'OTHER', 'fullName': 'Centre Antoine Lacassagne'}, 'officialTitle': 'Pilot Project - Prospective Longitudinal Cohort of Patients Over 70 Years With Malignant Solid Tumors: Modification of Quality of Life Based on Objective Geriatric Tests', 'orgStudyIdInfo': {'id': '2011/11 MEGERIA'}, 'secondaryIdInfos': [{'id': '2012-A01168-35', 'type': 'OTHER', 'domain': 'ANSM ID RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'A-Elderly patients with cancer', 'description': 'geriatric care and longitudinal follow up', 'interventionNames': ['Other: geriatric care and longitudinal follow up']}], 'interventions': [{'name': 'geriatric care and longitudinal follow up', 'type': 'OTHER', 'description': 'geriatric care and longitudinal follow up', 'armGroupLabels': ['A-Elderly patients with cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06189', 'city': 'Nice', 'country': 'France', 'facility': 'Centre Antoine LACASSAGNE', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Véronique MARI, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Antoine Lacassagne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Antoine Lacassagne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}