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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAugusto Caraceni

About this trial

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

Qualifiers

diagnosis of advanced/metastatic cancer

age > 18

Eastern Cooperative Oncology Group (ECOG) performance status ≥2

prognostic clinical prediction >1 month.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Structured Palliative Care
  • Classical Palliative Care

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Augusto Caraceni

Lead sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Sponsor institution