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NCT06150027 | RECRUITING | Cancer

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

Center Leon Berard

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.

Condition or disease

Cancer

Emergencies

Intervention/treatment

Systematic referral to a palliative care team

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 240 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : 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
Actual Study Start Date : 2024-09-12
Estimated Primary Completion Date : 2026-08
Estimated Study Completion Date : 2026-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Efficacy of a Systematic Referral to Palliative Care of Patients Who Need for Palliative Care During an Unscheduled Visit in Comprehensive Anticancer Centers

Location Details

NCT06150027

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

France,

Center Léon Bérard

Lyon, France, 69008

RECRUITING

France,

ICM Val d'Aurelle

Montpellier, France, 34090

RECRUITING

France,

Institut Curie - Paris

Paris, France, 75005

NOT YET RECRUITING

France,

Institut Curie - Saint Cloud

Saint-Cloud, France, 92210

RECRUITING

France,

Lorraine Cancer Institute

Vandevation-lès-Nancy, France, 54519

RECRUITING

France,

Gustave Roussy Institute

Villejuif, France, 94805