Benefits of Formalized Care Support Program Following Acute Leukemia Diagnosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: care support program after diagnosis announcement.
- Who it may be relevant to
- Registry conditions: Acute Leukemia. Basic parameters: 26 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Benefits of Formalized Care Support Program Following an Annoucement of Acute Leukemia Diagnosis
Overview
The purpose of this study is to determine the impact on anxiety between patients with a period of care support following their announcement of an acute leukemia (AL) diagnosis and patients without this accompaniment.
Detailed description
Patients answering the inclusion and exclusion criteria will be offered the opportunity to participate in the study by a nurse trained in this method of period of care support at the time of their announcement of an AL diagnosis. Patients will be given sufficient time to consider their decision. Following this period, patients who wish to participate will be included in the study, will sign the informed consent form and will be randomized (with or without a period of care support following their announcement of an AL diagnosis).
Patients in both groups will have their anxiety and quality of life questionnaire (QLQ-C30) assessed within the context of their usual care at T0 (at the time of the announcement).
Patients randomized in the arm with period of care support meet the nurse for this accompaniment within 7 days after the announcement.
Patients in both groups will have their anxiety at T1 (within 24 hours after the period of care support for the experimental group, same timeframe for the control group), and again their anxiety and quality of life at T2, two months (± 3 days) after admission to the intensive care unit. An evaluation questionnaire concerning period of care support will be given to the group benefiting from this care and a satisfaction questionnaire for the care will be given to patients in both groups at T2.
Interventions
- Other care support program after diagnosis announcement
a dedicated time with a specialized nurse in announcement will be given tot the patient. The anxiety will also be evaluated
Primary outcome measures
- Anxiety improvment [Time frame: 7 days after diagnosis announcement]
Eligibility criteria
Inclusion criteria
- informed consent signed
- medical confirmation of acute leukemia diagnosis
- age equal of superior to 26 years and under 80 years
- confirmed diagnosis not yet treated
- hospitalization at Centre Henri Becquerel
- member or beneficiary of a social security
Exclusion criteria
- -Patient unable to understand the study for any reason or to comply with the trial's requirements
- Patient in relapse of acute leukemia
- Patient diagnosed with acute myeloid leukemia 3
- History of cancer within the 5 years preceding the year of study enrollment
- Alcohol and drug abuse
- Inclusion in another therapeutic trial that prevents further enrollment in a trial evaluating quality of life or psychological well-being
- Diagnosed psychiatric illness
- Patient under guardianship, curatorship, or legal protection
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
France · 1 center
- Centre Henri Becquerel — Rouen
Identifiers
NCT: NCT07499765 · CHB25.01 · 2025-A00060-49