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

Léon Bérard Center

Status: Enrolling

Conditions: Emergencies; Cancer

Treatments: Other: Systematic referral to a palliative care team

Study type: Interventional

Funder types: Other

Identifiers

NCT06150027

ET22-175

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Standard

No Intervention group

Description:

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 group

Description:

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

Treatment:

Other: Systematic referral to a palliative care team