Benefits of Formalized Care Support Program Following Acu... | NCT07499765

Studies
Benefits of Formalized Care Support Program Following Acute Leukemia Diagnosis

NCT07499765

Sponsor

Centre Henri Becquerel

Status

Recruiting

Last Update Posted

Apr 29, 2026Actual

Enrollment

110Estimated

Phase

Not Applicable

Conditions

Acute Leukemia

Interventions

care support program after diagnosis announcement

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2025-A00060-49	Other Identifier	Ministry of Health

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 30, 2026Estimated

Primary Completion Date

Mar 30, 2029Estimated

Completion Date

Apr 15, 2029Estimated

First Submitted Date

Mar 24, 2026

First Submission Date that Met QC Criteria

Mar 24, 2026

First Posted Date

Mar 30, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2026

Last Update Posted Date

Apr 29, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

26 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Johan Le Fel, PhD	Contact	+232082918		johan.lefel@chb.unicancer.fr
Doriane Richard, PhD	Contact	+33232082985		doriane.richard@chb.unicancer.fr

Overall Officials

Name	Affiliation	Role
Fabrice Jardin, Md PhD	Centre Henri Becquerel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Henri Becquerel	Recruiting	Rouen			France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided