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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard | No Intervention | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systematic referral to a palliative care team | Other | 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. |
| 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 :
| From date of randomization until the date of death from any cause, assessed up to 30 months |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gisèle CHVETZOFF, MD,PhD | Centre Leon Berard | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Léon Bérard | Lyon | 69008 | France | |||
| ICM Val d'Aurelle |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40850913 | Derived | 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. |
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In the patient information sheet and informed consent form, the participants do not agree to share their individual personal data.
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Randomization (ratio 1:1) will be stratified according to the investigation center and pre-existing follow-up by pain management team.
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Montpellier |
| 34090 |
| France |
| Institut Curie - Paris | Paris | 75005 | France |
| Institut Curie - Saint Cloud | Saint-Cloud | 92210 | France |
| Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | 54519 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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