Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-28 @ 12:23 PM
Study NCT ID:
NCT04478903
Status:
COMPLETED
Last Update Posted:
2021-03-10
First Post:
2020-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perceived Burden and Quality of Life of Primary Caregivers of Cancer Patients Aged 70 and Older After 5 Years of Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-09', 'studyFirstSubmitDate': '2020-07-16', 'studyFirstSubmitQcDate': '2020-07-16', 'lastUpdatePostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the quality of life of the primary caregiver of cancer patients 70 years of age and older, 5 years after initial management.', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Quality of life is measured using the SF-12 (short form) questionnaire. This is an abbreviated version of the Medical Outcomes Study Short-form General Health survey (SF-36).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Quality of Life', 'Primary Patient Caregiver', 'Cancer']}, 'referencesModule': {'references': [{'pmid': '36729239', 'type': 'DERIVED', 'citation': 'Barben J, Billa O, Collot J, Collot T, Manckoundia P, Bengrine-Lefevre L, Dabakuyo-Yonli TS, Quipourt V. Quality of life and perceived burden of the primary caregiver of patients aged 70 and over with cancer 5 years after initial treatment. Support Care Cancer. 2023 Feb 2;31(2):147. doi: 10.1007/s00520-023-07594-w.'}]}, 'descriptionModule': {'briefSummary': "Cancer is a disease that requires long-term management, especially now that medical advances have transformed most cancers from an acute to a chronic condition. Most of the time, therefore, the help provided by family and friends is long-term.\n\nThe negative impact of oncological care on the quality of life of family caregivers has already been studied. The UCOGB carried out a study in 2014 on the primary caregivers of cancer patients aged 70 and over at inclusion and at 3 and 6 months of oncogeriatric care. This study showed that several factors were significantly related to the caregiver's quality of life: the caregiver's age, perception of burden and patient autonomy (18). However, the evolution of quality of life and burden at 5 years has, to our knowledge, never been evaluated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Retrieval of information and contact details of primary caregivers included in the 2014 study along with the patient's vital status", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Person who does not object to being included in the study\n* Primary caregiver of a cancer patient aged 70 years and over who is managed in one of the centres participating in the study, with a request for an oncogeriatric consultation between 01/06/2014 and 18/03/2015.\n* Age ≥ 18 years old\n* Good command of the French language\n\nExclusion Criteria:\n\n* Refusal or linguistic or psychological inability to answer the questionnaires.\n* Caregiver whose general condition does not allow him/her to answer a questionnaire\n* Death of the caregiver.'}, 'identificationModule': {'nctId': 'NCT04478903', 'acronym': 'FARAPPAC', 'briefTitle': 'Perceived Burden and Quality of Life of Primary Caregivers of Cancer Patients Aged 70 and Older After 5 Years of Management', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Perceived Burden and Quality of Life of Primary Caregivers of Cancer Patients Aged 70 and Older After 5 Years of Management', 'orgStudyIdInfo': {'id': 'QUIPOURT 2019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'primary caregiver of patients aged 70 and over', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Zarit Burden Inventory French version and SF12', 'armGroupLabels': ['primary caregiver of patients aged 70 and over']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'Chu Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}