Trial Title:
Efficacy of a Systematic Referral to Palliative Care of Patients Who Need for Palliative Care During an Unscheduled Visit in Comprehensive Anticancer Centers
NCT ID:
NCT06150027
Condition:
Cancer
Emergencies
Conditions: Official terms:
Emergencies
Conditions: Keywords:
Early palliative care
Cancer
Aggressiveness of care
Emergency
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Systematic referral to a palliative care team
Description:
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.
Arm group label:
Experimental
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Léon Bérard
Address:
City:
Lyon
Zip:
69008
Country:
France
Contact:
Last name:
Gisèle CHVETZOFF, MD,PhD
Phone:
04 78 78 26 57
Phone ext:
+33
Email:
gisele.chvetzoff@lyon.unicancer.fr
Facility:
Name:
ICM Val d'Aurelle
Address:
City:
Montpellier
Zip:
34090
Country:
France
Contact:
Last name:
Muriel THOMASO, MD
Phone:
04 67 61 47 32
Phone ext:
+33
Email:
muriel.thomaso@icm.unicancer.fr
Facility:
Name:
Institut Curie - Paris
Address:
City:
Paris
Zip:
75005
Country:
France
Contact:
Last name:
Carole BOULEUC, MD
Email:
carole.bouleuc@curie.fr
Facility:
Name:
Institut Curie - Saint Cloud
Address:
City:
Saint-Cloud
Zip:
92210
Country:
France
Contact:
Last name:
Marie-Ange MASSIANI, MD
Email:
-marie-ange.massiani@curie.fr
Facility:
Name:
Institut de Cancérologie de Lorraine
Address:
City:
Vandœuvre-lès-Nancy
Zip:
54519
Country:
France
Contact:
Last name:
Aline HENRY, MD
Phone:
03 83 59 83 31
Phone ext:
+33
Email:
a.henry@nancy.unicancer.fr
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Contact:
Last name:
Christine MATEUS, MD
Phone:
01 42 11 58 98
Phone ext:
+33
Email:
christine.mateus@gustaveroussy.fr
Start date:
August 2024
Completion date:
August 2026
Lead sponsor:
Agency:
Centre Leon Berard
Agency class:
Other
Source:
Centre Leon Berard
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06150027
