Expectations of Patients in Palliative Situation

NCT ID: NCT06786897

Last Updated: 2025-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-01

Study Completion Date

2028-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Myeloid Leukemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient

Patient in palliative situation

Questionnaire and Physical Exam

Intervention Type OTHER

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

Interventions

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Questionnaire and Physical Exam

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UH Montpellier

Montpellier, , France

Site Status

Countries

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France

Central Contacts

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Hugo NAVARRO

Role: CONTACT

0467336733

Olivier MAILLE, MD

Role: CONTACT

0467336733

Facility Contacts

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Hugo NAVARRO, Resident

Role: primary

0467336733

Olivier MAILLE, MD

Role: backup

0467336733

Other Identifiers

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2024-A02148-39

Identifier Type: OTHER

Identifier Source: secondary_id

RECHMPL24_0289

Identifier Type: -

Identifier Source: org_study_id

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