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

NCT07469761 | Recruiting DMC

• 1 other identifier: INT 101/25
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Palliative Care; Palliative Care, Health Services; Patient Reported Outcome (PRO); Patient Reported Outcome Measurements; Frailty; Cancer; Outpatient

Keywords

Patient Reported Outcome Measurements (PROMs); Outpatient; Palliative Care; Advanced cancer; Frailty; Palliative Care intervention

Outcome Measures

Primary Outcomes (2)

• 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.

  1, 3 months

• 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.

  1, 3 Months

Secondary Outcomes (4)

• Patients' satisfaction with care

  1, 3 months

• Healthcare resource utilization

  3, 6 months

• Differeces in End of Life (EoL) care aggressiveness criteria

  3, 6 months

• Caregivers' satisfaction with care

  1, 3 months

Study Arms (2)

Structured interventions tailored to PROMs cut-off

EXPERIMENTAL

• Experimental group, which will follow a structured palliative care pathway (specific intervention defined in the protocol) based on the frailties identified at baseline PROMs (defined by cut-off).

Other: Structured Palliative Care

Classic Palliative Car interventions

ACTIVE COMPARATOR

• Control group, which will undergo standard unstructured palliative care (based on PROMs as usual, but without cut-off or interventions' checklists)

Other: Classical Palliative Care

Interventions

Structured Palliative Care OTHER

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.

Structured interventions tailored to PROMs cut-off

Classical Palliative Care OTHER

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

Classic Palliative Car interventions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Augusto Caraceni: lead

Study Sites (1)

IRCCS Istituto Nazionale dei Tumori, Via Venezian n1

Milan, Lombardy, 20133, Italy

RECRUITING

MeSH Terms

Conditions

Frailty; Neoplasms

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Giacomo Massa, Dr

CONTACT

+39 0223903279/3272; giacomo.massa@Istitutotumori.mi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: This study adopts a pragmatic design, leveraging resources already available within routine palliative care services, while implementing predefined algorithms in which symptom and need thresholds (cut-offs) trigger tailored multidisciplinary interventions. In particular: * Control group, which will undergo standard unstructured palliative care (based on PROMs as usual, but without cut-off or interventions' checklists) * Experimental group, which will follow a structured palliative care pathway (specific intervention defined in the protocol) based on the frailties identified at baseline PROMs (defined by cut-off).

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 13, 2026
• Study Start: November 2, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 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.

Locations

IT (1)