Early Palliative Care in Patient With Acute Leukaemia

Study Overview
=================
Brief Summary
-----------------
Several studies have shown that patients with acute leukemia have many symptoms during disease These symptoms decrease the quality of life and may even appear or worsen other symptoms such as depression Several studies point to the involvement of supportive care and palliative care is delayed in these patients The aim of this study is to evaluate the impact on the quality of life of an early and standardized involvement of a support / palliative care team for patients with acute leukemia in first relapse compared to a control group .

Official Title
-----------------
Impact on Quality of Life of an Early Management Supportive Care of Patients With Acute Leukemia in First Relapse.

Conditions
-----------------
Acute Leukaemia in Relapse

Intervention / Treatment
-----------------
* Other: Supportive /palliative care intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years old acute lymphoblastic or myeloblastic leukemia at first relapse and diagnosed within 8 weeks before inclusion. Patients in whom a curative strategy (transplant) is not considered. patients older that 75 years at the diagnosis informed signed consent Exclusion Criteria: unable to answer the questionnaire psychiatric disorders other than depression persons under guardianship

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive /palliative care intervention<br>patients will be supported by a multidisciplinary palliative specialist team | Other: Supportive /palliative care intervention<br>* patients will be seen by palliative care team at least once a month until the 12th week, more if needed. The symptom and suffering will be assessed by a multidisciplinary palliative specialist team of physician, nurse and psychologist. Physical, psychological, social and existential suffering will be addressed.<br>|
| No Intervention: usual medical follow up<br>patients will be supported by the support care team if asked by the oncologist | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mesure of quality of life | Quality of life measured by FACT Leu questionnaire. score of quality of life will be compared between the 2 groups | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure of symptoms intensity | Symptom intensity measured by ESAS questionnaire. Score of symptoms intensity will be compared between the 2 groups | 12 weeks | 
| measure of depression | score of depression measured by HADS questionnaire. Score of depression will be compared between the 2 groups | 12 weeks | 
| measure of anxiety | score of anxiety measured by HADS questionnaire. score of anxiety will be compared between the 2 groups | 12 weeks | 
| measure of the quality of the end of life | Within the last month of life, several parameters will be studied to evaluate the quality of the end of life like number of admission in emergency unit. | up to 9 months | 
| overall survival |  | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute leukaemia, supportive / palliative care