Benefits of Formalized Care Support Program Following Acute Leukemia Diagnosis (ANX-LA)

April 24, 2026 updated by: Centre Henri Becquerel

Benefits of Formalized Care Support Program Following an Annoucement of Acute Leukemia Diagnosis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard arm
After randomization and diagnosis announcement, patient will be followed as usually
Experimental: Experimental arm
After randomization and diagnosis announcement, patient will have dedicated time with a nurse to explain in detail the diagnosis, the treatment. The anxiety will be also evaluated at different timepoints
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety improvment
Time Frame: 7 days after diagnosis announcement
variation of anxiety level using STAI questionnaire
7 days after diagnosis announcement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Henri Becquerel

Investigators

  • Principal Investigator: Fabrice Jardin, Md PhD, Centre Henri Becquerel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 30, 2026

Primary Completion (Estimated)

March 30, 2029

Study Completion (Estimated)

April 15, 2029

Study Registration Dates

First Submitted

March 24, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHB25.01
  • 2025-A00060-49 (Other Identifier: Ministry of Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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