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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
IRCCS Istituto Nazionale dei Tumori, Via Venezian n1
Milan, Lombardy, Italy
Start Date
November 2, 2025
Primary Completion Date
September 30, 2026
Completion Date
February 28, 2027
Last Updated
March 13, 2026
120
ESTIMATED participants
Structured Palliative Care
OTHER
Classical Palliative Care
OTHER
Lead Sponsor
Augusto Caraceni
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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