NCT06150027

Efficacy of a Systematic Referral to Palliative Care of Patients Who Need for Palliative Care During an Unscheduled Visit in Comprehensive Anticancer Centers

A Randomized Comparative Prospective Multicenter Study of the Efficacy of a Systematic Referral to Palliative Care of Patients Who Need for Palliative Care During an Unscheduled Visit in Comprehensive Anticancer Centers

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, multicenter, prospective, phase III study conducted in daily emergency rooms of French Regional Comprehensive Cancer Centers. In the standard arm, patients will be managed regardless of their PALLIA-10 score, following conventional strategy. In the experimental arm, patients will be systematically referred to a palliative care team.

Detailed description

This is a randomized, multicenter, prospective, phase III study conducted in daily emergency rooms of French Regional Comprehensive Cancer Centers. All patients undergoing a visit in the daily emergency room of a participating center and who need for palliative management (PALLIA 10 score \> 3/10) will be considered for inclusion in the PALLU study. After signing the written informed consent, patients will be randomized (1:1 ratio) in one of the following arms: * Standard arm : conventional strategy; patients will be managed regardless of their PALLIA-10 score. The need for additional care, including palliative care, will be assessed by the team in charge of the patient, as per routine practice. * Experimental arm : experimental strategy; patients will be systematically referred to a palliative care team. Randomization will be stratified according to the investigation center and pre-existing follow-up by pain management team. The difference of intervention will lie in the fact that patients will be referred or not to a palliative care team but patients from the standard arm may receive palliative care as deemed necessary by the medical oncology team. In this case, the content of palliative care for patients included in both groups will be identical. The end of the study will be the Last Patient Last Visit (LPLV), defined as the date of the 12-month visit of the last patient still alive or when the 192nd death has occurred, whichever occurs first.

Conditions

• Cancer
• Emergencies

Interventions

Type	Name	Description
OTHER	Systematic referral to a palliative care team	Patients randomized in the experimental arm will be systematically referred to a palliative care team. A follow-up in palliative care will be initiated for all within a maximum of 15 days after the date of randomization.

Timeline

• Start date: 2024-09-12
• Primary completion: 2026-04-01
• Completion: 2026-08-01
• First posted: 2023-11-29
• Last updated: 2026-02-17

Locations

6 sites across 1 country: France