Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-31 @ 9:35 PM
Study NCT ID:
NCT04310033
Status:
COMPLETED
Last Update Posted:
2021-09-01
First Post:
2020-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of ICU on the Quality of Life in Cancer Patients
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-31', 'studyFirstSubmitDate': '2020-02-20', 'studyFirstSubmitQcDate': '2020-03-12', 'lastUpdatePostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'quality of life questionary 36-item short form survey instrument (36-SF)', 'timeFrame': '3 months', 'description': 'score of 0 (poor quality of life) to 100 (very good quality of life)'}], 'secondaryOutcomes': [{'measure': 'intensity of antitumoral treatment compared to standard treatment', 'timeFrame': '3 months', 'description': 'standard treatment vs adaptated treatment vs palliative care standard treatment was defined by the treatment recommended in the ESMO guidelines for each cancer (lung, colorectal, and head and neck cancer)'}, {'measure': 'quality of life questionary 36-item short form survey instrument (36-SF)', 'timeFrame': '6 months', 'description': 'score of 0 (poor quality of life) to 100 (very good quality of life)'}, {'measure': 'intensity of antitumoral treatment compared to standard treatment', 'timeFrame': '6 months', 'description': 'standard treatment vs adaptated treatment vs palliative care standard treatment was defined by the treatment recommended in the ESMO guidelines for each cancer (lung, colorectal, and head and neck cancer)'}, {'measure': 'ECOG - Performance status', 'timeFrame': '3 months and 6 months', 'description': 'From 0 (fully active) to 5 (dead)'}, {'measure': 'Activities of Daily Living', 'timeFrame': '6 months', 'description': 'From 0 (dependent ) to 6 (autonomous)'}, {'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': '3 months and 6 months', 'description': 'Anxiety scale from 0 (no anxiety) to 21 (anxiety) Depression Scale from 0 (no depression) to 21 (depression)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Quality of life', 'Oncological care', 'intensive care unit', 'solid tumor'], 'conditions': ['Solid Tumor, Adult']}, 'descriptionModule': {'briefSummary': 'This is an observational, prospective, monocentric, case-control study. Investigators aim to compare the quality of life and oncological treatment strategy in cancer patients admitted or not in ICU.', 'detailedDescription': "Inclusion of cancer patients (cases) at discharge of surgical, cardiovascular and thoracic and medical ICU of the Grenoble Alpes University Hospital.\n\nCases will be matched with cancer patients identified in oncologist's consultation.\n\nInclusion of controls from oncologist consultations (2 controls for 1 case) For cases and controls, medical data will be collected at inclusion, 3 and 6 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Lung, head and neck or colorectal cancer admitted in ICU (cases) or not (controls)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 ans\n* Non-opposition of the patient or relatives\n* Lung, head and neck or colorectal cancer\n* Non scheduled ICU admission\n* At least 24 hours of ICU stay\n* Alive at ICU discharge\n* Able to answer by phone to quality of life questionary\n\nExclusion Criteria:\n\n* Unable to answer by phone to quality of life questionary\n* Patient participating in another clinical study that could interfere with the results of the study'}, 'identificationModule': {'nctId': 'NCT04310033', 'acronym': 'QdV-ONCOREA', 'briefTitle': 'Impact of ICU on the Quality of Life in Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Impact of ICU on the Quality of Life and Oncological Care of Patients With Solid Tumors', 'orgStudyIdInfo': {'id': '38RC19.420'}, 'secondaryIdInfos': [{'id': '2019-A03307-40', 'type': 'OTHER', 'domain': 'ID RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': '* \\> 18 years old\n* Non-opposition of the patient or relatives\n* Lung, head and neck or colorectal cancer\n* Non scheduled ICU admission\n* At least 24 hours of ICU stay\n* Alive at ICU discharge\n* Able to answer by phone to quality of life questionary', 'interventionNames': ['Other: Questionnaires']}, {'label': 'Controls', 'description': 'Cancer patients not admitted in ICU, matched with the cases according to\n\n* the type of primary cancer\n* the presence or absence of oncogenic addiction\n* the setting of anticancer treatment (curative/palliative)\n* the line of anticancer treatment (none/L1/L2-L3/\\>L3).', 'interventionNames': ['Other: Questionnaires']}], 'interventions': [{'name': 'Questionnaires', 'type': 'OTHER', 'description': 'Quality of life questionary: 36-Item Short Form Survey Instrument (36-SF) at 3 and 6 months from inclusion By phone', 'armGroupLabels': ['Cases', 'Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'Chu Grenoble Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}