Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-02-18 @ 7:03 AM
Study NCT ID:
NCT04628234
Status:
COMPLETED
Last Update Posted:
2021-02-01
First Post:
2020-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow-up of Actual Patient Care Site Two Months After Hospitalisation Compared With Their Expressed Choice Regarding Subsequent Care Site (RESPECT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-01-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-29', 'studyFirstSubmitDate': '2020-11-02', 'studyFirstSubmitQcDate': '2020-11-12', 'lastUpdatePostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients for which their choice of care and death -if occured- site (at hospital or at home) is respected.', 'timeFrame': '2 months after inclusion', 'description': 'Patients will fill out a questionnaire at inclusion and 2 months after inclusion if they are still alive. Death site will be collected from primary care physician if patient died.\n\nThe patient expressed choice regarding subsequent care and death site collected in the first questionnaire at inclusion will be compared to the situation at 2 months.'}], 'secondaryOutcomes': [{'measure': 'Number of new hospitalisations occuring after inclusion, if any.', 'timeFrame': '2 months after inclusion'}, {'measure': 'Duration of new hospitalisations occuring after inclusion, if any.', 'timeFrame': '2 months after inclusion'}, {'measure': 'Reasons for new hospitalisations occuring after inclusion, if any.', 'timeFrame': '2 months after inclusion'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematologic Malignancy', 'Tumor, Solid']}, 'descriptionModule': {'briefSummary': 'This is a non randomized, monocentric, descriptive, transversal and prospective study. The purpose of this study is to assess the compliance with patient expressed choice regarding subsequent care and death -if occured- site (at hospital or at home) after hospitalisation for terminally ill patients with an onco-hematologic solid tumor in palliative care and to identify reasons for potential non-compliance.', 'detailedDescription': 'Patients will reply to two questionnaires, at inclusion and two months after inclusion. Primary care physician will also be contacted by phone to reply to two questionnaires, at inclusion and two months after inclusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with an onco-hematologic solid tumor in palliative care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be ≥ 18 years old\n* Patients with onco-hematologic solid tumor (locally advanced or metastatic) against which specific and systemic treatments are outdated or have been stopped (symptomatic palliation with radiotherapy is allowed)\n* Patients admitted in full hospitalisation\n* Patients able to speak, read and understand French\n* Patients able to answer the phone\n* Signed informed consent from the patient\n* Patients must have a social security coverage\n\nExclusion Criteria:\n\n* Patients \\< 18 years old or incapable person ≥ 18 years old\n* Patients admitted for any surgical intervention\n* Patients unable to read French\n* Patients whose physical or psychological condition do not allow them to answer orally or in writing\n* Patients deprived of liberty\n* Patients placed under judicial protection\n* Women that are pregnant or breast-feeding'}, 'identificationModule': {'nctId': 'NCT04628234', 'acronym': 'RESPECT', 'briefTitle': 'Follow-up of Actual Patient Care Site Two Months After Hospitalisation Compared With Their Expressed Choice Regarding Subsequent Care Site (RESPECT)', 'organization': {'class': 'OTHER', 'fullName': 'Institut de cancérologie Strasbourg Europe'}, 'officialTitle': 'Follow-up of Actual Patient Care Site Two Months After Hospitalisation Compared With Their Expressed Choice Regarding Subsequent Care Site', 'orgStudyIdInfo': {'id': '2020-001'}, 'secondaryIdInfos': [{'id': '2020-A00439-30', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with an onco-hematologic solid tumor in palliative care'}]}, 'contactsLocationsModule': {'locations': [{'zip': '67033', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Institut de Cancerologie Strasbourg Europe', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de cancérologie Strasbourg Europe', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}