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

NCT ID: NCT06150027

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-12
• Study Completion Date: 2026-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Standard

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental

Experimental strategy: patients will be systematically referred to a palliative care team.

Group Type: EXPERIMENTAL

Systematic referral to a palliative care team

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male or female ≥ 18 years at the day of consenting to the study;
• Confirmed diagnosis of any type of solid or haematology tumours, with or without Current oncological treatment, such as chemotherapy, immunotherapy, targeted therapy, etc;
• Unscheduled admission in a French Regional Comprehensive Anti-Cancer Centre due to an acute, unpredictable, intercurrent event related to cancer, its therapies or a comorbidity;
• Patient for whom disease is considered as not curable;
• PALLIA-10 Score > 3/10;
• Willingness and ability to comply with the study requirements;
• Signed and dated informed consent indicating that the patient has been informed of all the aspects of the trial prior to enrolment;
• Patient must be covered by a medical insurance.

Exclusion Criteria

• Patient without consciousness, unable to provide a written informed consent (context of emergency);
• Patient treated with a curative intent;
• Previous randomization in this clinical study;
• Patients already followed-up by a palliative care team;
• Life expectancy shorter than 1 month, as per the emergency units' staff judgement.
• Any medical or psychosocial condition that would compromise the patient's compliance to the study visits or would likely interfere with the completion of Patient-Reported Outcomes.
• Patients under tutorship or curatorship.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Leon Berard

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gisèle CHVETZOFF, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Leon Berard

Locations

Centre Léon Bérard

Lyon, , France

Site Status: RECRUITING

ICM Val d'Aurelle

Montpellier, , France

Site Status: RECRUITING

Institut Curie - Paris

Paris, , France

Site Status: RECRUITING

Institut Curie - Saint Cloud

Saint-Cloud, , France

Site Status: NOT_YET_RECRUITING

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, , France

Site Status: RECRUITING

Institut Gustave Roussy

Villejuif, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Gisèle CHVETZOFF, MD, PhD

Role: CONTACT

gisele.chvetzoff@lyon.unicancer.fr

04 78 78 26 57 ext. +33

Julien GAUTIER

Role: CONTACT

julien.gautier@lyon.unicancer.fr

04 26 55 68 29 ext. +33

Facility Contacts

Gisèle CHVETZOFF, MD,PhD

Role: primary

gisele.chvetzoff@lyon.unicancer.fr

04 78 78 26 57 ext. +33

Muriel THOMASO, MD

Role: primary

muriel.thomaso@icm.unicancer.fr

04 67 61 47 32 ext. +33

Carole BOULEUC, MD

Role: primary

carole.bouleuc@curie.fr

Marie-Ange MASSIANI, MD

Role: primary

-marie-ange.massiani@curie.fr

Aline HENRY, MD

Role: primary

a.henry@nancy.unicancer.fr

03 83 59 83 31 ext. +33

Christine MATEUS, MD

Role: primary

christine.mateus@gustaveroussy.fr

01 42 11 58 98 ext. +33

References

Chvetzoff G, Anota A, Perrier L, Gautier J, Bouleuc C, Moreau P, Thomaso M, Le Divenah G, Henry A, Francois M, Massiani MA, Mateus C, Merad M, Bissuel L, Baudry AS, Christophe V, Russias B, Perol D. Systematic referral to palliative care in patients attending dedicated emergency units from French comprehensive anticancer centres: the prospective multicentre randomised comparative clinical trial PALLU. BMJ Open. 2025 Aug 24;15(8):e101299. doi: 10.1136/bmjopen-2025-101299.

Reference Type: DERIVED

PMID: 40850913 (View on PubMed)

Other Identifiers

ET22-175

Identifier Type: -

Identifier Source: org_study_id