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

Last updated: March 12, 2025
Sponsor: Centre Leon Berard
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer

Treatment

Systematic referral to a palliative care team

Clinical Study ID

NCT06150027
ET22-175
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 withoutCurrent oncological treatment, such as chemotherapy, immunotherapy, targetedtherapy, etc;

  • Unscheduled admission in a French Regional Comprehensive Anti-Cancer Centre due toan acute, unpredictable, intercurrent event related to cancer, its therapies or acomorbidity;

  • 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 ofall the aspects of the trial prior to enrolment;

  • Patient must be covered by a medical insurance.

Exclusion

Exclusion Criteria:

  • Patient without consciousness, unable to provide a written informed consent (contextof 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 complianceto the study visits or would likely interfere with the completion ofPatient-Reported Outcomes.

  • Patients under tutorship or curatorship.

Study Design

Total Participants: 240
Treatment Group(s): 1
Primary Treatment: Systematic referral to a palliative care team
Phase:
Study Start date:
September 12, 2024
Estimated Completion Date:
August 31, 2026

Study 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.

Connect with a study center

  • Centre Léon Bérard

    Lyon, 69008
    France

    Active - Recruiting

  • ICM Val d'Aurelle

    Montpellier, 34090
    France

    Active - Recruiting

  • Institut Curie - Paris

    Paris, 75005
    France

    Active - Recruiting

  • Institut Curie - Saint Cloud

    Saint-Cloud, 92210
    France

    Site Not Available

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519
    France

    Active - Recruiting

  • Institut Gustave Roussy

    Villejuif, 94805
    France

    Active - Recruiting

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