Clinical trial NCT06150027: Efficacy of a Systematic Referral to Palliative Care of Patients Who Need for Palliative Care During an Unscheduled Visit in Comprehensive Anticancer Centers
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Emergencies
Keywords: Early palliative care
Cancer
Aggressiveness of care
Emergency
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2023-11-29
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization (ratio 1:1) will be stratified according to the investigation center and pre-existing follow-up by pain management team.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Aggressiveness of care near the end of life
timeFrame: From date of randomization until the date of death from any cause, assessed up to 30 months
Secondary outcomes:
measure: More than 1 hospitalization in the last 30 days of life
timeFrame: From date of randomization until the date of death from any cause, assessed up to 48 months
measure: More than 1 visit in an emergency unit in the last 30 days of life
timeFrame: From date of randomization until the date of death from any cause, assessed up to 30 months
measure: More than 14 days in hospital in the last 30 days of life
timeFrame: From date of randomization until the date of death from any cause, assessed up to 30 months
measure: Hospitalization in a resuscitation unit in the last 30 days of life
timeFrame: From date of randomization until the date of death from any cause, assessed up to 30 months
measure: Treatment with chemotherapy in the last 14 days of life
timeFrame: From date of randomization until the date of death from any cause, assessed up to 30 months
measure: New chemotherapy regimen starting in the last 30 days of life
timeFrame: From date of randomization until the date of death from any cause, assessed up to 30 months
measure: Death in an acute care setting
timeFrame: At the date of death from any cause, assessed up to 30 months
measure: Medical resources mobilized in terms of palliative care
timeFrame: From date of randomization until the date of death from any cause, assessed up to 30 months
measure: Health-related quality of life using the FACT-G7 cancer specific questionnaire
timeFrame: At inclusion, 3 months, 6 months, 9 months and at 12 months
measure: Health-related quality of life using the HADS
timeFrame: At inclusion, 3 months, 6 months, 9 months and at 12 months
measure: Symptoms of cancer disease using the Edmonton Symptoms Assessment System (ESAS) symptom scores
timeFrame: From date of randomization until the date of death from any cause, assessed up to 30 months
measure: Place of death
timeFrame: At the date of death from any cause, assessed up to 30 months
measure: Overall Survival
timeFrame: At the date of death from any cause, assessed up to 30 months
Other outcomes:
measure: Health improvement (Life Year gained)
timeFrame: 12 months from randomization
measure: Health improvement (Quality-Adjusted Life Years gained)
timeFrame: 12 months from randomization
measure: Mean Total Costs
timeFrame: 12 months from randomization
measure: Impact of clinical variables on cost
timeFrame: 12 months from randomization
measure: Impact of patient variables on cost
timeFrame: 12 months from randomization
measure: Sensitivity Analyses
timeFrame: 12 months from randomization
measure: Incremental Cost-Effectiveness Ratio (ICER) per QALY gained
timeFrame: 12 months from randomization
measure: Incremental Cost-Effectiveness Ratio (ICER) per LY gained
timeFrame: 12 months from randomization
measure: Emergency healthcare professionals' perceptions of early palliative care before the beginning of recruitment
timeFrame: Before the beginning of recruitmentof in their centre
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard
city: Montpellier
country: France
facility: ICM Val d'Aurelle
city: Paris
country: France
facility: Institut Curie - Paris
city: Saint-Cloud
country: France
facility: Institut Curie - Saint Cloud
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Centre Leon Berard
name: Gisèle CHVETZOFF, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: