Multidisciplinary palliative care pathway tailored to frailty for outpatient advanced cancer patients
Official title: MultidISciplinary Care paThway tailoRed on frAilty in Cancer Patients Referred to Outpatient paLliative Care
Run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · NCT07469761 · Data updated 2026-11-12
This study will test whether a structured outpatient palliative care pathway that uses patient-reported symptom scores to tailor care can reduce symptoms and improve care experience for adults with advanced cancer and frailty.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Academic / other |
| Locations | 1 site (Milan, Lombardy) |
| Status | Recruiting |
| Started | November 2, 2025 |
| Main results expected | September 30, 2026 |
| Study ends | February 28, 2027 |
| Registry record updated | March 13, 2026 |
| Trial ID | NCT07469761 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (≥18) with advanced or metastatic cancer referred to outpatient palliative care who have ECOG performance status ≥2, an expected prognosis beyond one month, and the ability to complete PROM questionnaires and provide informed consent.
✕Probably not a fit
Patients with unstable medical conditions or serious psychiatric illness that prevent informed consent or participation, or those unable to complete PROMs, are unlikely to benefit from this pathway.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares a structured, PROM-driven palliative care pathway—using predefined cut-offs from patient-reported outcome measures—to usual outpatient palliative care. Participants are assigned to either the structured pathway or classical palliative care, with interventions delivered in an outpatient clinic setting. Primary outcomes include symptom burden and psychological distress, with secondary outcomes of patient and caregiver satisfaction and healthcare utilization such as emergency visits and hospital admissions. The trial enrolls adults with advanced or metastatic cancer who can complete PROMs and is conducted at a single cancer center in Milan.
Why it matters
Potential benefit: If successful, the pathway could improve symptom control and satisfaction while reducing emergency visits, hospital admissions, and healthcare costs for patients with advanced cancer.
How similar studies have gone: Previous PROM-triggered interventions in oncology have shown promise for improving symptom management and reducing healthcare use, but frailty-focused multidisciplinary outpatient pathways are less well studied.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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IRCCS Istituto Nazionale dei Tumori, Via Venezian n1
Milan, Lombardy, Italy Recruiting
Study contacts
- Study coordinator: Giacomo Massa, Dr
- Email: giacomo.massa@Istitutotumori.mi.it
- Phone: +39 0223903279/3272
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.