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OpenTrials
Completed

NCT Number: NCT02631811

Early Palliative Care in Patient With Acute Leukaemia

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 .

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Key information

Conditions

Acute Leukaemia in Relapse

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier LYON SUD

Pierre-Bénite, 69495, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supportive /palliative care intervention

Other

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 outcomes

  1. 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

Secondary outcomes

  1. 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

  2. measure of depression

    Time frame: 12 weeks

    score of depression measured by HADS questionnaire. Score of depression will be compared between the 2 groups

  3. measure of anxiety

    Time frame: 12 weeks

    score of anxiety measured by HADS questionnaire. score of anxiety will be compared between the 2 groups

  4. 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.

  5. overall survival

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: Pablo Hemato

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 16, 2015
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.