Early Palliative Care in Patient With Acute Leukaemia

Not Applicable

Completed

• Conditions: Acute Leukaemia in Relapse
• Interventions: Other: Supportive /palliative care intervention

• Registration Number: NCT02631811
• Lead Sponsor: Hospices Civils de Lyon

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 .

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-12-10
• Study First Submitted QC: 2015-12-11
• Study First Posted: 2015-12-16
• Study Start: 2016-02-09
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-04
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

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Exclusion Criteria

• unable to answer the questionnaire
• psychiatric disorders other than depression
• persons under guardianship

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supportive /palliative care intervention	Supportive /palliative care intervention	patients will be supported by a multidisciplinary palliative specialist team

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 anxiety	12 weeks	score of anxiety measured by HADS questionnaire. score of anxiety 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 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

Trial Locations

Locations (1)

Centre Hospitalier LYON SUD; 🇫🇷 Pierre Bénite, France