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Recruiting NCT07469761

MultidISciplinary Care paThway tailoRed on frAilty in Cancer Patients Referred to Outpatient paLliative Care

Trial Parameters

Condition Palliative Care
Sponsor Augusto Caraceni
Study Type INTERVENTIONAL
Phase N/A
Enrollment 120
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-11-02
Completion 2026-09-30
Interventions
Structured Palliative CareClassical Palliative Care

Brief Summary

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. Patients 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: Does 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? Researchers will compare two groups: Control group: Participants will receive standard outpatient palliative care. PROMs are collected as usual, but without predefined cut-offs or structured intervention checklists. Experimental 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.

Eligibility Criteria

Inclusion Criteria: * diagnosis of advanced/metastatic cancer * age \> 18 * Eastern Cooperative Oncology Group (ECOG) performance status ≥2 * prognostic clinical prediction \>1 month. Exclusion Criteria: * Serious medical or psychiatric illness that can interfere with informed consent and participation in this clinical study * any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.

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