Expectations of Patients in Palliative Situation

NCT06786897 | Not Yet Recruiting

• 2 other identifiers: RECHMPL24_02892024-A02148-39
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Myeloid Leukemia

Keywords

haematology; palliative situation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of days before death

  through study completion, an average of 1 year

Study Arms (1)

Patient

Patient in palliative situation

Other: Questionnaire and Physical Exam

Interventions

Questionnaire and Physical Exam OTHER

Questionnaires evaluating the expectations of patients in palliative situation, of paramedics and medical staff, concerning blood cell transfusions.

Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruted in palliative department of the hospital

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

UH Montpellier

Montpellier, 34000, France

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Surveys and Questionnaires; Restraint, Physical

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization

Central Study Contacts

Hugo NAVARRO

CONTACT

0467336733; hugo.navarro@chu-montpellier.fr

Olivier MAILLE, MD

CONTACT

0467336733; o-maille@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 22, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Access Criteria: Publication

Locations

FR (1)