Formalized nurse-led care support after an acute leukemia diagnosis
Benefits of Formalized Care Support Program Following an Annoucement of Acute Leukemia Diagnosis
NA · Centre Henri Becquerel · NCT07499765
This trial will test whether a structured nurse-led support visit after being told you have acute leukemia can reduce anxiety for adult patients hospitalized at Centre Henri Becquerel.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 26 Years to 80 Years |
| Sex | All |
| Sponsor | Centre Henri Becquerel (other) |
| Locations | 1 site (Rouen) |
| Trial ID | NCT07499765 on ClinicalTrials.gov |
What this trial studies
This is a randomized interventional study comparing a short period of structured, nurse-delivered care support given soon after the announcement of an acute leukemia diagnosis to usual care. Eligible adult patients (26–79 years) with a new, untreated acute leukemia hospitalized at Centre Henri Becquerel who can consent are randomized to receive the accompaniment within 7 days or to a control group. Anxiety and quality of life (QLQ-C30) are measured at baseline (T0), again shortly after the intervention or equivalent time (T1), and at two months (±3 days) after ICU admission (T2), with satisfaction and program-evaluation questionnaires collected at T2. The primary outcome is change in anxiety between groups, and both groups receive usual medical care throughout.
Who should consider this trial
Good fit: Adults aged 26 to 79 with a newly confirmed, untreated acute leukemia who are hospitalized at Centre Henri Becquerel and able to give informed consent are ideal candidates.
Not a fit: Patients with psychiatric illness, relapse or prior recent cancer, substance abuse, legal guardianship, or those enrolled in conflicting trials are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could lower short-term anxiety and improve quality of life for patients after an acute leukemia diagnosis.
How similar studies have performed: Nurse-led and psychosocial support interventions have reduced anxiety in other cancer settings, but formalized accompaniment specifically at acute leukemia diagnosis is relatively untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rouen
- Centre Henri Becquerel — Rouen, France (RECRUITING)
Study contacts
- Principal investigator: Fabrice Jardin, Md PhD — Centre Henri Becquerel
- Study coordinator: Johan Le Fel, PhD
- Email: johan.lefel@chb.unicancer.fr
- Phone: +232082918
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Leukemia, acute leukemia, anxiety, care support program