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

Sponsor
Augusto Caraceni
Study ID
NCT07469761
Status
Recruiting
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Conditions

  • Cancer
  • Frailty
  • Outpatient
  • Palliative Care
  • Palliative Care, Health Services
  • Patient Reported Outcome (PRO)
  • Patient Reported Outcome Measurements

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Structured Palliative Care — OTHER
    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.
  • Classical Palliative Care — OTHER
    Multidisciplinary palliative care interventions are delivered according to usual clinical practice, without activation based on predefined cut-offs or structured algorithms.

Study Details

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.

Key Dates

First listed
Mar 13, 2026
Start date
Nov 2, 2025
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Structured interventions tailored to PROMs cut-off
    • 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).
  • Active Comparator: Classic Palliative Car interventions
    • Control group, which will undergo standard unstructured palliative care (based on PROMs as usual, but without cut-off or interventions' checklists)

Primary Outcome Measure

Change in overall symptom burden assessed by the ESAS. [ Time Frame: 1, 3 months ]

Central Contacts

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