Actively Recruiting
Benefits of Formalized Care Support Program Following an Announcement of Acute Leukemia Diagnosis
Led by Centre Henri Becquerel · Updated on 2026-04-29
110
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the impact on anxiety in patients diagnosed with acute leukemia (AL) by comparing those who receive a period of care support following their diagnosis announcement with those who do not. The study focuses on how this specialized support might affect patients' anxiety levels and quality of life during a critical time after diagnosis. Participants are adults aged 26 to 80 years who are newly diagnosed and hospitalized for acute leukemia. Participants will be randomly assigned to one of two groups. One group will receive usual care without additional support, while the other group will have dedicated time with a nurse specialized in delivering the diagnosis and providing care support soon after the diagnosis announcement. Anxiety and quality of life will be assessed at multiple time points, including at diagnosis, shortly after the care support period, and two months after ICU admission. Patients in the care support group will also complete an evaluation of the support received, and all participants will fill out satisfaction questionnaires about their care. Throughout the study, patients will complete anxiety and quality of life questionnaires at specified times to measure changes and effects of the care support. The primary outcome measured is anxiety improvement seven days after the diagnosis announcement. Both groups will be monitored within their usual care setting, with assessments conducted shortly after diagnosis and following ICU admission. The study lasts through these scheduled assessments to understand the psychological effects of care support during this period.
CONDITIONS
Brief Title
Benefits of Formalized Care Support Program Following Acute Leukemia Diagnosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Medical confirmation of acute leukemia diagnosis
- Age 26 years or older and under 80 years
- Confirmed diagnosis not yet treated
- Hospitalization at Centre Henri Becquerel
- Member or beneficiary of social security
You will not qualify if you...
- Unable to understand the study or comply with trial requirements
- Patient in relapse of acute leukemia
- Diagnosis of acute myeloid leukemia 3
- History of cancer within 5 years before study enrollment
- Alcohol or drug abuse
- Participation in another trial evaluating quality of life or psychological well-being
- Diagnosed psychiatric illness
- Under guardianship, curatorship, or legal protection
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 7 days after diagnosis announcement
Participants randomized to the experimental arm meet a specialized nurse within 7 days after diagnosis announcement to receive dedicated care support and anxiety evaluation. Participants in the standard arm continue usual care.
1 visit (in-person) for care support group
Duration - Approximately 2 months
Participants in both groups complete anxiety and quality of life questionnaires at multiple timepoints including baseline, within 24 hours after care support or equivalent time for control, and approximately 2 months after intensive care unit admission.
3 questionnaire assessments at specified timepoints
Trial Site Locations
Total: 1 location
1
Centre Henri Becquerel
Rouen, France
Actively Recruiting
Research Team
J
Johan Le Fel, PhD
D
Doriane Richard, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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