Acute Leukaemia in Relapse
Conditions
Keywords
acute leukaemia, supportive / palliative care
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 .
Interventions
OTHERSupportive /palliative care intervention
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.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mesure of quality of life | 12 weeks | Quality of life measured by FACT Leu questionnaire. score of quality of life will be compared between the 2 groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| measure of symptoms intensity | 12 weeks | Symptom intensity measured by ESAS questionnaire. Score of symptoms intensity will be compared between the 2 groups |
| measure of depression | 12 weeks | score of depression measured by HADS questionnaire. Score of depression will be compared between the 2 groups |
| measure of anxiety | 12 weeks | score of anxiety measured by HADS questionnaire. score of anxiety will be compared between the 2 groups |
| measure of the quality of the end of life | up to 9 months | 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. |
| overall survival | 9 months | — |
Countries
France
Outcome results
None listed