Early Palliative Care in Patient With Acute Leukaemia

Acute Leukaemia in Relapse Clinical Trial

— Pablo Hemato  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02631811
• Other study ID #: 69HCL15_0305
• Status: Completed
• Phase: N/A
• Start date: February 9, 2016
• Est. completion date: October 1, 2020

Study information

• Verified date: February 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Disease
• Acute Leukaemia in Relapse
• Leukemia
• Recurrence

Intervention

Other:
• Supportive /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.

Locations

Country	Name	City	State
France	Centre Hospitalier LYON SUD	Pierre Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	measure of symptoms intensity	Symptom intensity measured by ESAS questionnaire. Score of symptoms intensity will be compared between the 2 groups	12 weeks
Secondary	measure of depression	score of depression measured by HADS questionnaire. Score of depression will be compared between the 2 groups	12 weeks
Secondary	measure of anxiety	score of anxiety measured by HADS questionnaire. score of anxiety will be compared between the 2 groups	12 weeks
Secondary	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
Secondary	overall survival		9 months