Multidisciplinary palliative care pathway tailored to frailty for outpatient advanced cancer patients
MultidISciplinary Care paThway tailoRed on frAilty in Cancer Patients Referred to Outpatient paLliative Care
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Academic / other |
| Locations | 1 site (Milan, Lombardy) |
| Trial ID | NCT07469761 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Milan, Lombardy
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.