MultidISciplinary Care paThway tailoRed on frAilty in Cancer Patients Referred to Outpatient paLliative Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Structured Palliative Care, Classical Palliative Care.
- Who it may be relevant to
- Registry conditions: Palliative Care, Palliative Care, Health Services, Patient Reported Outcome (PRO), Patient Reported Outcome Measurements. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other 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. - Other Classical Palliative Care
Multidisciplinary palliative care interventions are delivered according to usual clinical practice, without activation based on predefined cut-offs or structured algorithms.
Primary outcome measures
- Change in overall symptom burden assessed by the ESAS. [Time frame: 1, 3 months]
- Change in psychological distress assessed by the Distress Thermometer (DT). [Time frame: 1, 3 Months]
Secondary outcome measures (4)
- Patients' satisfaction with care [Time frame: 1, 3 months]
- Healthcare resource utilization [Time frame: 3, 6 months]
- Differeces in End of Life (EoL) care aggressiveness criteria [Time frame: 3, 6 months]
- Caregivers' satisfaction with care [Time frame: 1, 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Italy · 1 center
- IRCCS Istituto Nazionale dei Tumori, Via Venezian n1 — Milan
Identifiers
NCT: NCT07469761 · INT 101/25