Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-25 @ 7:32 PM
Study NCT ID:
NCT00921232
Status:
COMPLETED
Last Update Posted:
2012-07-23
First Post:
2009-05-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of the Burden Within the Dyad Patient/Caregiver
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-20', 'studyFirstSubmitDate': '2009-05-29', 'studyFirstSubmitQcDate': '2009-06-15', 'lastUpdatePostDateStruct': {'date': '2012-07-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Caregiver Reaction Assessment (CRA scale) completed by patient (hetero-perception) and its caregiver (auto-perception)', 'timeFrame': 'At baseline, to the announcement of the exclusive palliative care'}], 'secondaryOutcomes': [{'measure': 'Perception of the burden by the patient and its caregiver: search for potential predictive factors of the burden by statistic analysis HADS (The Hospital Anxiety and Depression Scale FRI (The Family Relationship Index)', 'timeFrame': 'At baseline, to the announcement of the exclusive palliative care'}, {'measure': 'Search for factors influencing the return at home of the life-ending patients by statistic analysis', 'timeFrame': 'Death'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Life-ending patient', 'caregiver'], 'conditions': ['Palliative Care']}, 'descriptionModule': {'briefSummary': 'This study is about the patients life ending and their caregiver, when a return to home is planned.\n\nThis is a behavioral sciences study (= interventional study for french law)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient \\> 18 years old\n* Cancer for which no curative treatment is envisaged\n* Palliative treatment only\n* For the caregiver: designated by the patient like the referring individual'}, 'identificationModule': {'nctId': 'NCT00921232', 'acronym': 'RAPSODIE', 'briefTitle': 'Assessment of the Burden Within the Dyad Patient/Caregiver', 'nctIdAliases': ['NCT00958594'], 'organization': {'class': 'OTHER', 'fullName': 'Centre Oscar Lambret'}, 'officialTitle': 'Crossed Assessment of the Burden Within the Dyad Patient/Caregiver: Analysis of Explanatory Factors and Consequences for Return at Home of the Life-ending Patient', 'orgStudyIdInfo': {'id': 'RAPSODIE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'dyad', 'description': 'life-ending patient and its caregiver', 'interventionNames': ['Behavioral: Questionnaires']}], 'interventions': [{'name': 'Questionnaires', 'type': 'BEHAVIORAL', 'description': 'During a consultation:\n\n* 3 questionnaires (HADS, FRI, CRA)\n* and a form for the sociodemographic data', 'armGroupLabels': ['dyad']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59020', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Nicolas PENEL, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Oscar Lambret'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Oscar Lambret', 'class': 'OTHER'}, 'collaborators': [{'name': 'Unité de REcherche en sciences Cognitives et Affectives URECA EA1059', 'class': 'UNKNOWN'}, {'name': 'University of Lille Nord de France', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}