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.
diagnosis of advanced/metastatic cancer
age > 18
Eastern Cooperative Oncology Group (ECOG) performance status ≥2
prognostic clinical prediction >1 month.
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.
Parallel
Structured Palliative Care
Other interventionSymptoms/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 interventionMultidisciplinary palliative care interventions are delivered according to usual clinical practice, without activation based on predefined cut-offs or structured algorithms.
Change in overall symptom burden assessed by the ESAS.
\- 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).
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.
Patients' satisfaction with care
The higher satisfaction with care after a structured intervention based on baseline PROMs. Endpoints: improvement in satisfaction with care measured by FAMCARE (Family Satisfaction with Advanced Cancer Care)-P13. This self-administered questionnaire utilizes a 5-point Likert scale (from 1 = "very dissatisfied" to 5 = "very satisfied"), range 0-65, where the total score is directly proportional to satisfaction levels (higher scores indicate more satisfaction).
Healthcare resource utilization
the differences between the experimental and control groups concerning the number of total visits, emergency room admissions, and urgent hospital admissions during the follow-up
Differeces in End of Life (EoL) care aggressiveness criteria
the differences between the experimental and control groups concerning the number of emergency room admissions, oncological therapy (radiotherapy, surgery, systemic), and hospitalizations occurring within 30 days of death (end of life, EoL).
Caregivers' satisfaction with care
The higher satisfaction with care after a structured intervention based on baseline PROMs. Endpoints: improvement in satisfaction with care, measured by FAMCARE (Family Satisfaction with Advanced Cancer Care). This self-administered questionnaire utilizes a 5-point Likert scale (from 1 = "very dissatisfied" to 5 = "very satisfied"), range 0-85, where the total score is directly proportional to satisfaction levels (higher scores indicate more satisfaction).
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Augusto Caraceni
Lead sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor institution
