Early Palliative Care in Patient With Acute Leukaemia (Pablo Hemato)

September 11, 2025 updated by: Hospices Civils de Lyon

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

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pierre-Bénite, France, 69495
        • Centre Hospitalier Lyon Sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supportive /palliative care intervention
patients will be supported by a multidisciplinary palliative specialist team
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.
No Intervention: usual medical follow up
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
Time Frame: 12 weeks
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
overall survival
Time Frame: 9 months
9 months
measure of symptoms intensity
Time Frame: 12 weeks
Symptom intensity measured by ESAS questionnaire. Score of symptoms intensity will be compared between the 2 groups
12 weeks
measure of depression
Time Frame: 12 weeks
score of depression measured by HADS questionnaire. Score of depression will be compared between the 2 groups
12 weeks
measure of anxiety
Time Frame: 12 weeks
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
Time Frame: 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.
up to 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2016

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

December 10, 2015

First Submitted That Met QC Criteria

December 11, 2015

First Posted (Estimated)

December 16, 2015

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 11, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL15_0305

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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