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

NCT06150027 | Active Not Recruiting

• 1 other identifier: ET22-175
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 6

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.

Conditions

Cancer; Emergencies

Keywords

Early palliative care; Cancer; Aggressiveness of care; Emergency

Outcome Measures

Primary Outcomes (1)

• Aggressiveness of care near the end of life

  Percentage and number of patients who meet at least one of the following criteria : * More than 1 hospitalization in the last 30 days of life; * More than 1 visit in an emergency unit in the last 30 days of life; * More than 14 days in hospital in the last 30 days of life; * Hospitalization in a resuscitation unit in the last 30 days of life; * Treatment with systemic anticancer therapy in the last 14 days of life; * New systemic anticancer therapy regimen starting in the last 30 days of life; * Patients dying in an acute care setting.

  From date of randomization until the date of death from any cause, assessed up to 30 months

Secondary Outcomes (13)

• More than 1 hospitalization in the last 30 days of life

  From date of randomization until the date of death from any cause, assessed up to 48 months

• More than 1 visit in an emergency unit in the last 30 days of life

  From date of randomization until the date of death from any cause, assessed up to 30 months

• More than 14 days in hospital in the last 30 days of life

  From date of randomization until the date of death from any cause, assessed up to 30 months

• Hospitalization in a resuscitation unit in the last 30 days of life

  From date of randomization until the date of death from any cause, assessed up to 30 months

• Treatment with chemotherapy in the last 14 days of life

  From date of randomization until the date of death from any cause, assessed up to 30 months

Other Outcomes (9)

• Health improvement (Life Year gained)

  12 months from randomization

• Health improvement (Quality-Adjusted Life Years gained)

  12 months from randomization

• Mean Total Costs

  12 months from randomization

Study Arms (2)

Standard

NO INTERVENTION

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

EXPERIMENTAL

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

Other: Systematic referral to a palliative care team

Interventions

Systematic referral to a palliative care team 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.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (6)

Centre Léon Bérard

Lyon, 69008, France

Location

ICM Val d'Aurelle

Montpellier, 34090, France

Location

Institut Curie - Paris

Paris, 75005, France

Location

Institut Curie - Saint Cloud

Saint-Cloud, 92210, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Related Publications (1)

• 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.

  PMID: 40850913 DERIVED

MeSH Terms

Conditions

Neoplasms; Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gisèle CHVETZOFF, MD,PhD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization (ratio 1:1) will be stratified according to the investigation center and pre-existing follow-up by pain management team.

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 29, 2023
• Study Start: September 12, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)