An interventional study of Systematic referral to a palliative care team in Cancer and Emergencies, sponsored by Centre Leon Berard. Active, not recruiting at 6 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by Centre Leon Berard · Not applicable, Interventional, and Other
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.
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:
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 240 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Centre Leon Berard is the lead sponsor of 206 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
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 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.
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.
Time frame: From date of randomization until the date of death from any cause, assessed up to 30 months
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: At the date of death from any cause, assessed up to 30 months
Health improvement (Life Year gained)
Health improvement will be measured in Life Year (LY) gained.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 12 months from randomization
Sensitivity Analyses
One-way sensitivity analyses varying all cost items by minimal and maximal values observed in the sample
Time frame: 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.
Time frame: 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.
Time frame: 12 months from randomization
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.
Time frame: Before the beginning of recruitmentof in their centre
Plan to share: No — In the patient information sheet and informed consent form, the participants do not agree to share their individual personal data.
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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