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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Emergencies; Cancer
• Intervention / Treatment: Other: Systematic referral 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.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69008
    • Centre Leon Berard
  • Montpellier, France, 34090
    • Icm Val D'Aurelle
  • Paris, France, 75005
    • Institut Curie - Paris
  • Saint-Cloud, France, 92210
    • Institut Curie - Saint Cloud
  • Vandœuvre-lès-Nancy, France, 54519
    • Institut de Cancerologie de Lorraine
  • Villejuif, France, 94805
    • Institut Gustave Roussy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard; 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; Experimental strategy: patients will be systematically referred to a palliative care team.	Other: Systematic referral to a palliative care team; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aggressiveness of care near the end of life	Percentage and number of patients who meet at least one of the following criteria : More than 1 hospitalization in the last 30 days of life;; More than 1 visit in an emergency unit in the last 30 days of life;; More than 14 days in hospital in the last 30 days of life;; Hospitalization in a resuscitation unit in the last 30 days of life;; Treatment with systemic anticancer therapy in the last 14 days of life;; New systemic anticancer therapy regimen starting in the last 30 days of life;; Patients dying in an acute care setting.	From date of randomization until the date of death from any cause, assessed up to 30 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
More than 1 hospitalization in the last 30 days of life	Percentage and number of patients having more than 1 hospitalization in the last 30 days of life	From date of randomization until the date of death from any cause, assessed up to 48 months
More than 1 visit in an emergency unit in the last 30 days of life	Percentage and number of patients having more than 1 visit in an emergency unit in the last 30 days of life	From date of randomization until the date of death from any cause, assessed up to 30 months
More than 14 days in hospital in the last 30 days of life	Percentage and number of patients having more than 14 days in hospital in the last 30 days of life	From date of randomization until the date of death from any cause, assessed up to 30 months
Hospitalization in a resuscitation unit in the last 30 days of life	Percentage and number of patients having a hospitalization in a resuscitation unit in the last 30 days of life	From date of randomization until the date of death from any cause, assessed up to 30 months
Treatment with chemotherapy in the last 14 days of life	Percentage and number of patients having a treatment with chemotherapy in the last 14 days of life	From date of randomization until the date of death from any cause, assessed up to 30 months
New chemotherapy regimen starting in the last 30 days of life	Percentage and number of patients having a new chemotherapy regimen starting in the last 30 days of life	From date of randomization until the date of death from any cause, assessed up to 30 months
Death in an acute care setting	Percentage and number of patients dying in an acute care setting	At the date of death from any cause, assessed up to 30 months
Medical resources mobilized in terms of palliative care	Medical resources mobilized in terms of palliative care (psychologist, social worker, nutritional counselling, etc.) will be described for the interventional group in terms of number and percentage of patients with at least one consultation with each specialist	From date of randomization until the date of death from any cause, assessed up to 30 months
Health-related quality of life using the FACT-G7 cancer specific questionnaire	The total score ranges from 0 and 28, with a higher score indicates better quality of life. Scores will be described per randomized group at each measurement time (inclusion,3 months and 6 months) using same criteria as for other quantitative variables (number of observations, mean, standard deviation, median, minimum and maximum values).	At inclusion, 3 months, 6 months, 9 months and at 12 months
Health-related quality of life using the HADS	One score is generated for anxiety and one score for depression on a 0 to 21 points, with a higher score indicates higher level of trouble. Scores will be described per randomized group at each measurement time (inclusion,3 months and 6 months) using same criteria as for other quantitative variables (number of observations, mean, standard deviation, median, minimum and maximum values). Number and percentage of patients without anxiety or depression trouble (i.e. with a score of 7 or lower), moderate trouble (score between 8 to 10) and severe trouble (score of 11 or more) will be reported.	At inclusion, 3 months, 6 months, 9 months and at 12 months
Symptoms of cancer disease using the Edmonton Symptoms Assessment System (ESAS) symptom scores	Pain, tiredness, drowsiness, nausea, lack of appetite, depression, anxiety, shortness of breath, and wellbeing and patient-specific symptoms are each described on a scale ranging from 0 to 10 (10 being the worst). The mean change in symptoms will be estimated from baseline and at each follow-up time. The ESAS symptom scores will be calculated according to the authors' recommendations and described per randomized group at each time point by mean, standard deviation, median and range.	From date of randomization until the date of death from any cause, assessed up to 30 months
Place of death	Hospital and type of unit or home will be described per randomized group	At the date of death from any cause, assessed up to 30 months
Overall Survival	Defined as the time from the date of inclusion to the date of death due to any cause.	At the date of death from any cause, assessed up to 30 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergency healthcare professionals' perceptions of early palliative care before the beginning of recruitment	Described by the potential factors limiting or facilitating the referral of patients to palliative caregivers. Descriptive analyses will be done. Quantitative variables will be described with mean (standard deviation) and median (min-max). Qualitative variables will be described with numbers and percentages.	Before the beginning of recruitmentof in their centre
Health improvement (Life Year gained)	Health improvement will be measured in Life Year (LY) gained.	12 months from randomization
Health improvement (Quality-Adjusted Life Years gained)	Health improvement will be measured in Quality-Adjusted Life Years (QALY) gained, based on the EQ-5D-5L assessments, performed at inclusion, 3 months, 6 months, 9 months and at 12 months. For EQ-5D-5L, 5 attributes will therefore be investigated: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each attributes having five levels. The score falls on the 0.0 (dead) to 1.0 (perfect health) value scale. The value set for the EQ-5D-5L based on societal preferences of the French population will be used. QALYs will be calculated as the sum of QALY of each of the periods weighted by it respective probability. Effects will be also not discounted.	12 months from randomization
Mean Total Costs	Mean total costs associated with each strategy, including hospital care, outpatient care, medical goods, transport, and palliative support.	12 months from randomization
Sensitivity Analyses	One-way sensitivity analyses varying all cost items by minimal and maximal values observed in the sample	12 months from randomization
Incremental Cost-Effectiveness Ratio (ICER) per QALY gained	The ICER will compare the cost per QALY gained between the experimental strategy and the conventional strategy. QALY gained will be based on the EQ-5D-5L assessments, performed at inclusion, 3 months, 6 months, 9 months and at 12 months. For EQ-5D-5L, 5 attributes will therefore be investigated: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each attributes having five levels. The score falls on the 0.0 (dead) to 1.0 (perfect health) value scale. The value set for the EQ-5D-5L based on societal preferences of the French population will be used. QALYs will be calculated as the sum of QALY of each of the periods weighted by it respective probability. Effects will be also not discounted.	12 months from randomization
Incremental Cost-Effectiveness Ratio (ICER) per LY gained	The ICER will compare the cost per LY gained between the experimental strategy and the conventional strategy.	12 months from randomization
Impact of clinical variables on cost	Multiple regression analyses will be performed to examine the correlation between costs and a range of potentially explanatory clinical variables	12 months from randomization
Impact of patient variables on cost	Multiple regression analyses will be performed to examine the correlation between costs and a range of potentially explanatory patient variables	12 months from randomization

Collaborators and Investigators

• Sponsor: Centre Leon Berard
• Investigators: Principal Investigator: Gisèle CHVETZOFF, MD,PhD, Centre Leon Berard

Publications and helpful links

General Publications

• Chvetzoff G, Anota A, Perrier L, Gautier J, Bouleuc C, Moreau P, Thomaso M, Le Divenah G, Henry A, Francois M, Massiani MA, Mateus C, Merad M, Bissuel L, Baudry AS, Christophe V, Russias B, Perol D. Systematic referral to palliative care in patients attending dedicated emergency units from French comprehensive anticancer centres: the prospective multicentre randomised comparative clinical trial PALLU. BMJ Open. 2025 Aug 24;15(8):e101299. doi: 10.1136/bmjopen-2025-101299.

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: November 17, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Actual): November 29, 2023

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; Emergency; Early palliative care; Aggressiveness of care
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Neoplasms; Emergencies
• Other Study ID Numbers: ET22-175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: In the patient information sheet and informed consent form, the participants do not agree to share their individual personal data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No