Actively Recruiting

Phase Not Applicable
Age: 26Years - 80Years
All Genders
ID07499765

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

Age: 26Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Care Support Program

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

Anxiety and Quality of Life Assessments

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

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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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