Acute Leukemia
Conditions
Keywords
acute leukemia, anxiety, care support program
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.
Interventions
OTHERcare support program after diagnosis announcement
a dedicated time with a specialized nurse in announcement will be given tot the patient. The anxiety will also be evaluated
Sponsors
Centre Henri Becquerel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
26 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety improvment | 7 days after diagnosis announcement | variation of anxiety level using STAI questionnaire |
Countries
France
Contacts
CONTACTJohan Le Fel, PhD
CONTACTDoriane Richard, PhD
PRINCIPAL_INVESTIGATORFabrice Jardin, Md PhD
Centre Henri Becquerel
Outcome results
None listed