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NCT Number: NCT07499765

Benefits of Formalized Care Support Program Following 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.

Recruiting

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Key information

Age range

26 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

care support program after diagnosis announcement

Other

a dedicated time with a specialized nurse in announcement will be given tot the patient. The anxiety will also be evaluated

Primary outcomes

  1. Anxiety improvment

    Time frame: 7 days after diagnosis announcement

    variation of anxiety level using STAI questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Doriane Richard, PhD

CONTACT

[email protected]

+33232082985

Johan Le Fel, PhD

CONTACT

[email protected]

+232082918

Sponsors and collaborators

Lead sponsor

Centre Henri Becquerel

Other

Registry information

Official study title

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

Acronym: ANX-LA

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 30, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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