Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-28 @ 1:01 PM
Study NCT ID:
NCT04936568
Status:
COMPLETED
Last Update Posted:
2025-07-08
First Post:
2021-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Palliative Care Referral System (PCRS) for Cancer Patients With Advanced Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A quasi-experimental, longitudinal, pretest-posttest study will be carried out. Two different cohorts of 150 advanced cancer patients each will be enrolled before (pretest) and after (posttest) the introduction of the PCRS in outpatient clinics.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 380}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2021-06-08', 'studyFirstSubmitQcDate': '2021-06-22', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'patient reported experience', 'timeFrame': 'through study completion, up to 6 months', 'description': 'patient satisfaction with care, measured with the FAMCARE-P13'}], 'secondaryOutcomes': [{'measure': 'Health related quality of life', 'timeFrame': 'through study completion, up to 6 months', 'description': 'European Organisation for Research and Treatment of Cancer - Quality of Life -Palliative Care questionnaire (Eortc QLQC15-PAL)'}, {'measure': 'caregiver experience of care', 'timeFrame': 'through study completion, up to 6 months', 'description': 'Family Care Satisfaction scale (FAMCARE)'}, {'measure': 'Activation of a Palliative Care service', 'timeFrame': 'through study completion, up to 6 months', 'description': 'Number of regular outpatient Palliative Care visits'}, {'measure': 'Multidisciplinary team visits', 'timeFrame': 'through study completion, up to 6 months', 'description': 'Number of multidisciplinary team visits (Oncology and Palliative Care)'}, {'measure': 'Hospitalization', 'timeFrame': 'through study completion, up to 6 months', 'description': 'Number of hospitalizations'}, {'measure': 'Emergency department accesses', 'timeFrame': 'through study completion, up to 6 months', 'description': 'Number of accesses in Emergency departement'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['early palliative care', 'referral'], 'conditions': ['Advanced Cancer']}, 'referencesModule': {'references': [{'pmid': '36307164', 'type': 'DERIVED', 'citation': 'Brunelli C, Zecca E, Pigni A, Bracchi P, Caputo M, Lo Dico S, Fusetti V, Tallarita A, Bergamini C, Brambilla M, Raimondi A, Niger M, Provenzano S, Sepe P, Alfieri S, Tine G, De Braud F, Caraceni AT. Outpatient palliative care referral system (PCRS) for patients with advanced cancer: an impact evaluation protocol. BMJ Open. 2022 Oct 28;12(10):e059410. doi: 10.1136/bmjopen-2021-059410.'}]}, 'descriptionModule': {'briefSummary': 'Early palliative care (EPC) in the clinical pathway of advanced cancer patients improves symptom control, quality of life and has a positive impact on overall quality of care. EPC contributes to realistic and attainable goals of treatment, facilitating patient choices, favouring adequate communication with patients and families and assessing patient values and preferences with regard to advance care planning. EPC is likely to promote a more appropriate use of health care resources and less aggressive cancer treatment in the last weeks of life. At present standardised criteria for appropriate referral for EPC in oncology outpatients setting are lacking. Therefore the aim of this project is to identify referral criteria and procedures to implement appropriate EPC for advanced patients (the Palliative Care Referral System) and test them in a pre-post experimental design evaluating their impact on quality of care and on the use of healthcare resources. A quasi-experimental, longitudinal, pretest-posttest study will be carried out. Two different cohorts of 150 advanced cancer patients each will be enrolled before (pretest) and after (posttest) the introduction of the PCRS in outpatient clinics of a Comprehensive Cancer Centre. Eligible patients will undergo patient-reported outcome measure (PROMs) evaluation at baseline and then monthly for at least 6 months from enrollment or till death. Use health care resources and quality of care indicators will be collected monthly by a dedicated research nurse.', 'detailedDescription': 'As above.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>18 years;\n* recent diagnosis of inoperable locally advanced and/or metastatic cancer not eligible to anticancer treatment with curative intent;\n\nExclusion Criteria:\n\n* cognitive impairment that would prevent self-assessments\n* current palliative care treatment'}, 'identificationModule': {'nctId': 'NCT04936568', 'acronym': 'PCRSS', 'briefTitle': 'Palliative Care Referral System (PCRS) for Cancer Patients With Advanced Disease', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano'}, 'officialTitle': 'Implementation of a Standardized Palliative Care Referral System (PCRS) for Cancer Patients With Advanced Disease: Impact on Patient and Caregiver Satisfaction With Care and Use of Health Care Resources.', 'orgStudyIdInfo': {'id': '201/19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'standard oncology care'}, {'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': 'standardized referral to outpatient palliative care by oncologists', 'interventionNames': ['Other: Palliative Care Referral System - PCRS']}], 'interventions': [{'name': 'Palliative Care Referral System - PCRS', 'type': 'OTHER', 'description': 'Implementation of a system to help oncologists to identify criteria for referring patients to specialized outpatient palliative care (Palliative Care Referral System - PCRS)', 'armGroupLabels': ['intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20133', 'city': 'Milan', 'state': 'Milan', 'country': 'Italy', 'facility': 'Fondazione IRCCS Istituto Nazionale dei Tumori', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Augusto T Caraceni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'not planned'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'director of Palliative Care Unit', 'investigatorFullName': 'Augusto Caraceni', 'investigatorAffiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano'}}}}