Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 4:58 AM
Study NCT ID:
NCT07469761
Status:
RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MultidISciplinary Care paThway tailoRed on frAilty in Cancer Patients Referred to Outpatient paLliative Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "This study adopts a pragmatic design, leveraging resources already available within routine palliative care services, while implementing predefined algorithms in which symptom and need thresholds (cut-offs) trigger tailored multidisciplinary interventions. In particular:\n\n* Control group, which will undergo standard unstructured palliative care (based on PROMs as usual, but without cut-off or interventions' checklists)\n* Experimental group, which will follow a structured palliative care pathway (specific intervention defined in the protocol) based on the frailties identified at baseline PROMs (defined by cut-off)."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-03-05', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in overall symptom burden assessed by the ESAS.', 'timeFrame': '1, 3 months', 'description': '\\- Mean change in symptom burden from baseline to 1 month after initiation of palliative care, measured using the Edmonton Symptom Assessment System (ESAS) total score (range 0-90, higher scores indicating greater symptom burden). The analysis will compare the change in ESAS total score between the two randomized groups.'}, {'measure': 'Change in psychological distress assessed by the Distress Thermometer (DT).', 'timeFrame': '1, 3 Months', 'description': 'Mean change in psychological distress from baseline to 1 month after initiation of palliative care, measured using the Distress Thermometer (DT) (range 0-10, higher scores indicating greater distress). The analysis will compare the change in DT score between the two randomized groups.'}], 'secondaryOutcomes': [{'measure': "Patients' satisfaction with care", 'timeFrame': '1, 3 months', 'description': 'The higher satisfaction with care after a structured intervention based on baseline PROMs. Endpoints: improvement in satisfaction with care measured by FAMCARE (Family Satisfaction with Advanced Cancer Care)-P13. This self-administered questionnaire utilizes a 5-point Likert scale (from 1 = "very dissatisfied" to 5 = "very satisfied"), range 0-65, where the total score is directly proportional to satisfaction levels (higher scores indicate more satisfaction).'}, {'measure': 'Healthcare resource utilization', 'timeFrame': '3, 6 months', 'description': 'the differences between the experimental and control groups concerning the number of total visits, emergency room admissions, and urgent hospital admissions during the follow-up'}, {'measure': 'Differeces in End of Life (EoL) care aggressiveness criteria', 'timeFrame': '3, 6 months', 'description': 'the differences between the experimental and control groups concerning the number of emergency room admissions, oncological therapy (radiotherapy, surgery, systemic), and hospitalizations occurring within 30 days of death (end of life, EoL).'}, {'measure': "Caregivers' satisfaction with care", 'timeFrame': '1, 3 months', 'description': 'The higher satisfaction with care after a structured intervention based on baseline PROMs. Endpoints: improvement in satisfaction with care, measured by FAMCARE (Family Satisfaction with Advanced Cancer Care). This self-administered questionnaire utilizes a 5-point Likert scale (from 1 = "very dissatisfied" to 5 = "very satisfied"), range 0-85, where the total score is directly proportional to satisfaction levels (higher scores indicate more satisfaction).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patient Reported Outcome Measurements (PROMs)', 'Outpatient', 'Palliative Care', 'Advanced cancer', 'Frailty', 'Palliative Care intervention'], 'conditions': ['Palliative Care', 'Palliative Care, Health Services', 'Patient Reported Outcome (PRO)', 'Patient Reported Outcome Measurements', 'Frailty', 'Cancer', 'Outpatient']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to learn whether a structured, Patient-Reported Outcome Measures (PROMs)-tailored palliative care pathway improves clinical outcomes and care experience in adults with advanced cancer referred to outpatient palliative care.\n\nPatients with advanced cancer often experience multiple symptoms and complex needs. Standard outpatient palliative care is usually guided by clinical judgment on patient-reported questionnaires. In this study, researchers aim to test whether a more structured approach, based on predefined cut-offs from PROMs, can improve symptom control, satisfaction with care, and use of healthcare resources. The main questions the study aims to answer are:\n\nDoes a structured, PROM-driven palliative care pathway reduce symptom burden and psychological distress compared with usual care? And through this, to improve patients' and caregivers' satisfaction with care or reduce emergency room visits, hospital admissions, healthcare costs, and aggressive treatments near the end of life?\n\nResearchers will compare two groups:\n\nControl group: Participants will receive standard outpatient palliative care. PROMs are collected as usual, but without predefined cut-offs or structured intervention checklists.\n\nExperimental group: Participants will receive a structured palliative care pathway tailored to symptoms/needs identified at baseline using PROM cut-offs. Specific multidisciplinary interventions are activated according to identified needs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of advanced/metastatic cancer\n* age \\> 18\n* Eastern Cooperative Oncology Group (ECOG) performance status ≥2\n* prognostic clinical prediction \\>1 month.\n\nExclusion Criteria:\n\n* Serious medical or psychiatric illness that can interfere with informed consent and participation in this clinical study\n* any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.'}, 'identificationModule': {'nctId': 'NCT07469761', 'acronym': 'MISTRAL', 'briefTitle': 'MultidISciplinary Care paThway tailoRed on frAilty in Cancer Patients Referred to Outpatient paLliative Care', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano'}, 'officialTitle': 'MultidISciplinary Care paThway tailoRed on frAilty in Cancer Patients Referred to Outpatient paLliative Care', 'orgStudyIdInfo': {'id': 'INT 101/25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Structured interventions tailored to PROMs cut-off', 'description': '• Experimental group, which will follow a structured palliative care pathway (specific intervention defined in the protocol) based on the frailties identified at baseline PROMs (defined by cut-off).', 'interventionNames': ['Other: Structured Palliative Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Classic Palliative Car interventions', 'description': "• Control group, which will undergo standard unstructured palliative care (based on PROMs as usual, but without cut-off or interventions' checklists)", 'interventionNames': ['Other: Classical Palliative Care']}], 'interventions': [{'name': 'Structured Palliative Care', 'type': 'OTHER', 'description': 'Symptoms/needs domains are defined according to protocol-specified cut-offs, followed by the activation of a tailored intervention based on structured checklists targeting the reported symptoms/needs.', 'armGroupLabels': ['Structured interventions tailored to PROMs cut-off']}, {'name': 'Classical Palliative Care', 'type': 'OTHER', 'description': 'Multidisciplinary palliative care interventions are delivered according to usual clinical practice, without activation based on predefined cut-offs or structured algorithms.', 'armGroupLabels': ['Classic Palliative Car interventions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20133', 'city': 'Milan', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giacomo Massa, Dr', 'role': 'CONTACT', 'email': 'giacomo.massa@istitutotumori.mi.it', 'phone': '+39 0223903279/3272'}], 'facility': 'IRCCS Istituto Nazionale dei Tumori, Via Venezian n1', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Giacomo Massa, Dr', 'role': 'CONTACT', 'email': 'giacomo.massa@Istitutotumori.mi.it', 'phone': '+39 0223903279/3272'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'The study protocol, statistical analysis plan, and informed consent form template will be made available upon reasonable request following study registration and may be shared prior to publication. De-identified individual participant data underlying the published results, together with a data dictionary, will be made available beginning 6 months after publication of the primary results and for at least 5 years thereafter. Data will be shared through a controlled access process, subject to submission of a methodologically sound proposal, approval by the study steering committee, and execution of a Data Access Agreement, in compliance with GDPR and GCP standards.', 'ipdSharing': 'YES', 'description': 'De-identified IPD underlying published results, together with the study protocol, statistical analysis plan, and data dictionary, will be shared in line with the FAIR principles and the "as open as possible, as closed as necessary" approach of Horizon Europe. Data management will follow a predefined Data Management Plan and comply with Regulation (EU) 2016/679 (GDPR) and GCP standards.\n\nData will be available from 6 months after publication for at least 5 years through controlled access, subject to a scientifically sound proposal, steering committee approval, and a Data Access Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Augusto Caraceni', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Augusto Caraceni', 'investigatorAffiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano'}}}}