Clinical trial · Interventional
MultidISciplinary Care paThway tailoRed on frAilty in Cancer Patients Referred to Outpatient paLliative Care
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Frailty | — | UNRESOLVED | — |
| Outpatient | — | UNRESOLVED | — |
| Palliative Care | — | UNRESOLVED | — |
| Palliative Care, Health Services | — | UNRESOLVED | — |
| Patient Reported Outcome Measurements | — | UNRESOLVED | — |
| Patient Reported Outcome (PRO) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Classical Palliative Care | Other | — | UNRESOLVED |
| Structured Palliative Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Structured interventions tailored to PROMs cut-off
- description
- • 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).
- interventionNames
- Other: Structured Palliative Care
- type
- ACTIVE_COMPARATOR
- label
- Classic Palliative Car interventions
- description
- • Control group, which will undergo standard unstructured palliative care (based on PROMs as usual, but without cut-off or interventions' checklists)
- interventionNames
- Other: Classical Palliative Care
Primary outcomes (2)
- measure
- Change in overall symptom burden assessed by the ESAS.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available