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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 6-month visit of the last patient still alive or when the 192nd death has occurred, whichever occurs first.

Official Title
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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

Conditions
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Cancer, Emergencies

Intervention / Treatment
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* Other: Systematic referral to a palliative care team


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization (ratio 1:1) will be stratified according to the investigation center and pre-existing follow-up by pain management team.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard<br>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<br>Experimental strategy: patients will be systematically referred to a palliative care team. | Other: Systematic referral to a palliative care team<br>* 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.<br>|

What is the study measuring?
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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 chemotherapy in the last 14 days of life; New chemotherapy 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 48 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 48 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 48 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 48 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 48 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 48 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 48 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 48 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, at 3 months and at 6 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, at 3 months and at 6 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 48 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 48 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 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early palliative care, Cancer, Aggressiveness of care, Emergency