Acute LeukemiaANX-LANCT07499765
Benefits of Formalized Care Support Program Following Acute Leukemia Diagnosis
A study testing care support program after diagnosis announcement in people with Acute Leukemia, run by Centre Henri Becquerel at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 26 to 80 years
- Conditions the study is for
- Acute Leukemia
- What is being tested?
- care support program after diagnosis announcement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 30 Mar 2026to 15 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Henri Becquerel
Rouen
patricia Fleury, +33232082985, patricia.fleury@chb.unicancer.fr
Doriane Richard, +33232082985, doriane.richard@chb.unicancer.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Leukemia
- Being tested
- care support program after diagnosis announcement
- Keywords
- acute leukemia, anxiety, care support program
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
care support program after diagnosis announcementOther
a dedicated time with a specialized nurse in announcement will be given tot the patient. The anxiety will also be evaluated
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: care support program after diagnosis announcement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety improvment
variation of anxiety level using STAI questionnaire
Measured: 7 days after diagnosis announcement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start30 Mar 2026 (estimated)
- Primary completion30 Mar 2029 (estimated)
- Study completion15 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice Jardin, Md PhD, Principal investigator, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499765
- Sponsor's protocol ID
- CHB25.01
- Other IDs
- 2025-A00060-49
- Acronym
- ANX-LA
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Formalized Care Support Program Following an Annoucement of Acute Leukemia Diagnosis
- ClinicalTrials.gov ID
- NCT07499765
- Acronym / sponsor ID
- ANX-LA / CHB25.01
- Conditions
- Acute Leukemia
- Keywords
- acute leukemia, anxiety, care support program
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 15 Apr 2029 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard arm | No intervention | –After randomization and diagnosis announcement, patient will be followed as usually |
| Experimental arm | Experimental | Other: care support program after diagnosis announcementAfter 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 |
Who may qualify
- Ages
- 26 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- -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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| care support program after diagnosis announcementa dedicated time with a specialized nurse in announcement will be given tot the patient. The anxiety will also be evaluated | Other | Experimental arm |
Primary outcome
Anxiety improvment
Time frame: 7 days after diagnosis announcement
variation of anxiety level using STAI questionnaire
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fabrice Jardin, Md PhD principal investigator
Centre Henri Becquerel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing care support program after diagnosis announcement in people with Acute Leukemia, run by Centre Henri Becquerel at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johan Le Fel, PhD (+232082918, johan.lefel@chb.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety improvment (time frame: 7 days after diagnosis announcement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.