Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 11:13 PM
Study NCT ID:
NCT05681793
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2022-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Survey on the Clinical Assessment of the Psychological Status of a Patient Over 75 Years Old in Oncology During the Realization of the G8 Score (CADEPO)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-20', 'studyFirstSubmitDate': '2022-12-28', 'studyFirstSubmitQcDate': '2022-12-28', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison the medical hetero-evaluation of depressive symptoms via the G8 "neuro-psychiatric disorders" item score with a self-evaluation via the GDS-15 score, in patients over 75 years of age with cancer and follow-up in oncology', 'timeFrame': '2 months', 'description': 'Difference between the evaluation of the health professionals of the item "Neuropsychiatric problems" of the G8 score (no depression versus moderate or severe depression) and the responses of the patients to the self-administered questionnaire GDS-15 (Geriatric Depression Scale) ( 0 to 4: normal versus 5 to 15: moderate to severe depression).'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the number of patients over 75 on antidepressants included in this study', 'timeFrame': '2 months', 'description': 'Percentage of patients included in this study and being treated with antidepressants'}, {'measure': 'Evaluation of the proportion of patients with depressive symptoms according to the predisposing factors with a sociodemographic sheet and from the medical file', 'timeFrame': '2 months', 'description': 'Percentage of patients with depressive symptoms according to the predisposing factors (age, gender, housing in urban or rural areas,distance (in travel time) between the oncology department and home, social isolation, income, marital status, socio-professional category, type of cancer), taken from a sociodemographic sheet distributed to the patient and from the medical file'}, {'measure': 'Compare the number of patients followed in oncogeriatrics over the period from 01/01/22 to 02/28/22 and the period from 01/01/2023 to 02/28/2023', 'timeFrame': '2 months', 'description': 'Percentage of patients followed in oncogeriatrics over the period from 01/01/2022 to 02/28/2022 and the period from 01/01/2023 to 02/28/2023'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to make a statement concerning the identification of depressive symptoms at the time of the realization of the G8 score in patients over 75 with cancer and followed in oncology.\n\nThe main question it aims to answer are:\n\n* Compare the medical hetero-evaluation of depressive symptoms via the G8 "neuro-psychiatric disorders" item score with a self-evaluation via the GDS-15 score\n* Evaluate the number of patients over 75 treated with antidepressants\n* Evaluate the proportion of patients with depressive symptoms according to the predisposing factors\n* Compare the number of patients followed in oncogeriatrics over the period from 01/01/2022 to 02/28/2022 and the period from 01/01/2023 to 02/28/2023\n\nParticipants will complete a self-questionnaire (GDS-15 score) as well as a socio-demographic sheet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '75 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients over 75 presenting eligibility criteria and undergoing oncological treatment and coming for consultation in the Hôpital Nord Franche-Comté', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 75 and over\n* Patients receiving treatment at the day hospital or oncology week hospital\n* Patients informed and having not presented any opposition to their participation\n\nExclusion Criteria:\n\n* Patients under the age of 75\n* Patients under guardianship or curatorship\n* Patients without social security\n* Cognitive disorders compromising the understanding of the information and the performance of the study (in particular the completion of a self-administered questionnaire), in the opinion of the oncologist'}, 'identificationModule': {'nctId': 'NCT05681793', 'acronym': 'CADEPO', 'briefTitle': 'Survey on the Clinical Assessment of the Psychological Status of a Patient Over 75 Years Old in Oncology During the Realization of the G8 Score (CADEPO)', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Nord Franche-Comte'}, 'officialTitle': 'Survey on the Clinical Assessment of the Psychological Status of a Patient Over 75 Years Old in Oncology During the Realization of the G8 Score', 'orgStudyIdInfo': {'id': '2022-A02329-34'}}, 'contactsLocationsModule': {'locations': [{'zip': '90400', 'city': 'Trévenans', 'country': 'France', 'facility': 'Hôpital Nord Franche-Comté', 'geoPoint': {'lat': 47.56667, 'lon': 6.86667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Nord Franche-Comte', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}