NCT07499765

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
35mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Mar 2026Apr 2029

First Submitted

Initial submission to the registry

March 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

March 30, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2029

Expected
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2029

Last Updated

April 29, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

March 24, 2026

Last Update Submit

April 24, 2026

Conditions

Keywords

acute leukemiaanxietycare support program

Outcome Measures

Primary Outcomes (1)

  • Anxiety improvment

    variation of anxiety level using STAI questionnaire

    7 days after diagnosis announcement

Study Arms (2)

Standard arm

NO INTERVENTION

After randomization and diagnosis announcement, patient will be followed as usually

Experimental arm

EXPERIMENTAL

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

Interventions

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

Experimental arm

Eligibility Criteria

Age26 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Diagnosed psychiatric illness
  • Patient under guardianship, curatorship, or legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Henri Becquerel

Rouen, France

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Fabrice Jardin, Md PhD

    Centre Henri Becquerel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2026

First Posted

March 30, 2026

Study Start

March 30, 2026

Primary Completion (Estimated)

March 30, 2029

Study Completion (Estimated)

April 15, 2029

Last Updated

April 29, 2026

Record last verified: 2026-03

Locations