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.

Inclusion Criteria:

• diagnosis of advanced/metastatic cancer
• age > 18
• Eastern Cooperative Oncology Group (ECOG) performance status ≥2
• prognostic clinical prediction >1 month.

Exclusion Criteria:

• 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.

De-identified IPD underlying published results, together with the study protocol, statistical analysis plan, and data dictionary, will be shared in line with the FAIR principles and the "as open as possible, as closed as necessary" approach of Horizon Europe. Data management will follow a predefined Data Management Plan and comply with Regulation (EU) 2016/679 (GDPR) and GCP standards.

Data will be available from 6 months after publication for at least 5 years through controlled access, subject to a scientifically sound proposal, steering committee approval, and a Data Access Agreement.

The study protocol, statistical analysis plan, and informed consent form template will be made available upon reasonable request following study registration and may be shared prior to publication. De-identified individual participant data underlying the published results, together with a data dictionary, will be made available beginning 6 months after publication of the primary results and for at least 5 years thereafter. Data will be shared through a controlled access process, subject to submission of a methodologically sound proposal, approval by the study steering committee, and execution of a Data Access Agreement, in compliance with GDPR and GCP standards.