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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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

Primary outcome measure(s)

• Change in overall symptom burden assessed by the ESAS. — 1, 3 months
  \- 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.
• Change in psychological distress assessed by the Distress Thermometer (DT). — 1, 3 Months
  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.

Trial sites (1)

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