Expectations of Patients in Palliative Situation (ERAPH)

Expectations of Patients in Palliative Situation and Their Caregivers Concerning Blood Cell Transfusions in Haematology Department

To date, there is a lack of data about the benefit of blood cell transfusions for patients diagnosed of a hematologic malignancy who are not eligible for curative treatments. Furthermore, there is no clear guideline about how to transfuse these patients and when the blood cell transfusions should be stopped.

Allogenic stem cell transplantation is nowadays the only curative treatment for patients with high-risk myeloid neoplasms. Knowing that the median age at diagnostic for acute myeloid leukemia is 68 years and this incidence increases after 65 years, a lot of patients won't be eligible for allogenic stem cell transplantation.

Besides, patients with haematologic malignancies are prone to cytopenias, due to their pathology and the treatments used to limit its progression. A study estimate that these patients need a median of 4 blood cell units per month, and it is known that repeated transfusions are associated with an increased risk of dying in hospital.

Finally, it is estimate that there was a lack of 20 000 blood cell units in France in 2022.

It therefore seems essential to find ways to optimize blood transfusion prescriptions in this population of patients who won't be eligible for curative treatments, with the main idea of maintaining or even improving their quality of life.

The investigators will study the expectations of patients in palliative situation, paramedics and medical staff concerning blood cell transfusions, by asking them if whether or not they believe that the transfusion planed to be administer will benefit the patient. To do this, investigators will distribute questionnaires before each blood cell transfusions to patients who will be included, to the paramedic who administered the transfusion and to the physician who prescribed the transfusion.

It is to investigators knowledge the first study to compare the expectations of patients in palliative situation, paramedics and medical staff concerning blood cell transfusions in hematology department, and follow the evolution of these expectations prospectively.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Myeloid Leukemia
• Intervention / Treatment: Other: Questionnaire and Physical Exam

• Study Type: Observational
• Enrollment (Estimated): 37

Contacts and Locations

• Study Contact: Name: Hugo NAVARRO; Phone Number: 0467336733; Email: hugo.navarro@chu-montpellier.fr
• Study Contact Backup: Name: Olivier MAILLE, MD; Phone Number: 0467336733; Email: o-maille@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34000
    • UH Montpellier
    • Contact: Olivier MAILLE, MD; Phone Number: 0467336733; Email: o-maille@chu-montpellier.fr
    • Contact: Hugo NAVARRO, Resident; Phone Number: 0467336733; Email: hugo-navarro@chu-montpellier.fr
    • Principal Investigator: Hugo NAVARRO, Resident
    • Sub-Investigator: Olivier MAILLE, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruted in palliative department of the hospital

Description

Inclusion Criteria:

• Patients aged 18 years or more AND
• Diagnosed of an intermediate or high-risk acute leukemia and not eligible for allogenic stem cell transplantation Or
• Diagnosed of a high-risk myelodisplasic syndrome and not eligible for allogenic stem cell transplantation Or
• Diagnosed of an intermediate or high-risk myelofibrosis and not eligible for allogenic stem cell transplantation Or
• Diagnosed of a chronic myeloid leukemia in blast crisis phase and not eligible for allogenic stem cell transplantation Or
• Relapsing after allogenic stem cell transplantation and not eligible for a second allogenic stem cell transplantation

Exclusion criteria:

• Patients who can't read
• Patients who can't write
• Patients who can't express their consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient; Patient in palliative situation	Other: Questionnaire and Physical Exam; Questionnaires evaluating the expectations of patients in palliative situation, of paramedics and medical staff, concerning blood cell transfusions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the benefit of blood cell transfusion before each blood cell transfusion	Evaluate the concordance for the perceptions of the benefit of blood cell transfusions in a palliative situation in hematology department between patients, paramedical and medical staff	up to 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days before death	Define the median number of days before death, from which patients believe they no longer benefit from blood transfusions	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: January 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 19, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: haematology; palliative situation
• Other Study ID Numbers: RECHMPL24_0289; 2024-A02148-39 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Publication of the results
• IPD Sharing Access Criteria: Publication
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No