Back to resultsEarly Palliative Care in Patient With Acute Leukaemia (Pablo Hemato)
Primary Purpose
Acute Leukaemia in Relapse
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Supportive /palliative care intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Leukaemia in Relapse focused on measuring acute leukaemia, supportive / palliative care
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
Sites / Locations
- Centre Hospitalier LYON SUD
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Supportive /palliative care intervention
usual medical follow up
Arm Description
patients will be supported by a multidisciplinary palliative specialist team
patients will be supported by the support care team if asked by the oncologist
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
measure of symptoms intensity
Symptom intensity measured by ESAS questionnaire. Score of symptoms intensity will be compared between the 2 groups
measure of depression
score of depression measured by HADS questionnaire. Score of depression will be compared between the 2 groups
measure of anxiety
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
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
Full Information
NCT ID
NCT02631811
First Posted
December 10, 2015
Last Updated
February 4, 2021
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT02631811
Brief Title
Early Palliative Care in Patient With Acute Leukaemia
Acronym
Pablo Hemato
Official Title
Impact on Quality of Life of an Early Management Supportive Care of Patients With Acute Leukemia in First Relapse.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 9, 2016 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Leukaemia in Relapse
Keywords
acute leukaemia, supportive / palliative care
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supportive /palliative care intervention
Arm Type
Experimental
Arm Description
patients will be supported by a multidisciplinary palliative specialist team
Arm Title
usual medical follow up
Arm Type
No Intervention
Arm Description
patients will be supported by the support care team if asked by the oncologist
Intervention Type
Other
Intervention Name(s)
Supportive /palliative care intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
mesure of quality of life
Description
Quality of life measured by FACT Leu questionnaire. score of quality of life will be compared between the 2 groups
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
measure of symptoms intensity
Description
Symptom intensity measured by ESAS questionnaire. Score of symptoms intensity will be compared between the 2 groups
Time Frame
12 weeks
Title
measure of depression
Description
score of depression measured by HADS questionnaire. Score of depression will be compared between the 2 groups
Time Frame
12 weeks
Title
measure of anxiety
Description
score of anxiety measured by HADS questionnaire. score of anxiety will be compared between the 2 groups
Time Frame
12 weeks
Title
measure of the quality of the end of life
Description
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.
Time Frame
up to 9 months
Title
overall survival
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Centre Hospitalier LYON SUD
City
Pierre Bénite
ZIP/Postal Code
69495
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Early Palliative Care in Patient With Acute Leukaemia
We'll reach out to this number within 24 hrs