Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-01-01 @ 6:37 AM
Study NCT ID:
NCT03261128
Status:
COMPLETED
Last Update Posted:
2019-01-29
First Post:
2017-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tool for the Detection of Oncogeriatric Fragility in Patients Aged ≥75 Years Undergoing Oncological Treatment.(D-FOG)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-28', 'studyFirstSubmitDate': '2017-08-04', 'studyFirstSubmitQcDate': '2017-08-22', 'lastUpdatePostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the feasibility of a new geriatric fragility screening tool (D-FOG) in patients aged ≥ 75 years during oncological treatment.', 'timeFrame': '3 months', 'description': 'Feasibility of D-FOG for patients : number of D-FOGs filled in, regularity of the D-FOG self-questionnaire by the patient, number of criteria entered by D-FOG, criterion analysis of D-FOG'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer', 'chemotherapy'], 'conditions': ['75 Years Old and More', 'Cancer', 'Chemotherapy']}, 'descriptionModule': {'briefSummary': 'Many cancers are diagnosed after 75 years. Treatment in chemotherapy begins without evidence of geriatric risk factors. A new tool for screening for geriatric fragilities is used, a self-administered questionnaire carried out by the patient before each chemotherapy cure. The objective is to secure the quality of patient care and to detect the appearance and / or aggravation of geriatric fragilities.', 'detailedDescription': 'Evaluation of the feasibility of a new geriatric fragility screening tool (D-FOG) in patients aged ≥ 75 years during oncological treatment:\n\n* Number of D-FOGs filled in: comparison with the number of patients included in the study and the number of visits of each patient.\n* Regularity of the D-FOG self-questionnaire by the patient: comparison with the number of visits of the patient for a chemotherapy cure (HDJ or HDS).\n* Number of criteria entered by D-FOG: comparison with the total number of criteria to be filled in\n* Criterion analysis of D-FOG'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 75 years and over Cancer and treated with chemotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 75 years and over\n* Carriers of diagnosed cancer (excluding hematology)\n* Whatever the location, uniqueness or multiple, duration of development and treatment status (adjuvant, neoadjuvant, locally advanced or metastatic)\n* Seen in nursing consultant\n* Beginning an oncological treatment\n* Supported for oncology day hospital (HDJ) or weekly (HDS) chemotherapy\n* Patient not opposed to participate in the study\n\nExclusion Criteria:\n\n* Patients under 75 years of age\n* Having not had an IDE ad consultation\n* During oncological treatment\n* Receiving Oral Therapy or hormone therapy alone\n* Treated by radiotherapy alone or surgery alone\n* Not attending a day or week oncology hospital\n* Refusal to participate in research'}, 'identificationModule': {'nctId': 'NCT03261128', 'acronym': 'D-FOG', 'briefTitle': 'Tool for the Detection of Oncogeriatric Fragility in Patients Aged ≥75 Years Undergoing Oncological Treatment.(D-FOG)', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'officialTitle': 'Tool for the Detection of Oncogeriatric Fragility in Patients Aged ≥75 Years Undergoing Oncological Treatment. Feasibility and Acceptability Study.', 'orgStudyIdInfo': {'id': '2017-A02188-45'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group D-FOG', 'description': 'Filling of a self-questionnaire before each chemotherapy cure', 'interventionNames': ['Other: Self-questionnaire']}], 'interventions': [{'name': 'Self-questionnaire', 'type': 'OTHER', 'description': 'Filling of a self-questionnaire before each chemotherapy cure', 'armGroupLabels': ['Group D-FOG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}], 'overallOfficials': [{'name': 'VALERO SV SIMON, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Poitiers'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}