Chronic Leukemia
Conditions
Brief summary
The objective of this project is to evaluate, over a 12-month period, the feasibility of integrating a digital tool into the follow-up care of patients with chronic myeloid leukemia who have been off treatment for up to 2 years. Feasibility will be assessed based on the usage rate, defined as the proportion of patients who accessed the digital tool at least: * once a month, if treatment discontinuation was ≤ 6 months; * once a quarter, if treatment discontinuation was \> 6 months. The usage rate will be assessed and compared to a threshold of 60%; if the rate falls below this threshold, feasibility will be considered insufficient.
Interventions
OTHERIntegration of a digital tool
Integration of a digital tool into the follow-up care of patients with CML who have been off treatment for up to 2 years.
Sponsors
Versailles Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 or older * Patients with chronic myeloid leukemia who have been off treatment for ≤ 2 years * Patients with access to a digital device with internet access * Be enrolled in the social security system * Have given verbal consent after reviewing the study information sheet
Exclusion criteria
* Patients who cannot read or understand French; * Individuals entitled to enhanced protection, namely minors, individuals deprived of their liberty by a judicial or administrative decision, individuals staying in a health or social care facility, adults under legal guardianship, and, finally, patients in emergency situations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility will be assessed based on the usage rate, defined as the proportion of patients who accessed the digital tool at least: - once a month, if treatment interruption is ≤ 6 months; - once a quarter, if treatment interruption is > 6 months. | 12 months | To evaluate, over a 12-month period, the feasibility of integrating a digital tool into the care of patients with chronic myeloid leukemia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of times patients used the device. | 12 months | Assess how often the device is used. |
| The number of days between when the blood test is performed and when the IPA and the patient view the results on the device. | 12 months | Assess the time it takes for the Study Nurse and the patient to access laboratory results. |
| The frequency with which patients contact the study nurse through the system's communication module. | 12 months | Evaluate the use of the digital device's data exchange module between the patient and the Study Nurse |
| Anxiety scores will be assessed at enrollment, at M3, M6, and M12 using the 7-item Generalized Anxiety Disorder Screening Scale (GAD-7) (scores range from 0 to 21). | 12 months | To study anxiety symptoms and their progression over the course of follow-up. |
| Changes in the GAD-7 anxiety score (0 to 21) based on the duration of treatment interruption (months) and the frequence | 12 months | To examine the relationship between changes in anxiety scores based on the duration of treatment interruption and the use of the device. |
| Patient satisfaction will be assessed using a questionnaire designed specifically for this population, consisting of 9 items (with a score ranging from 0 to 36) and a numerical scale for overall satisfaction ranging from 0 to 10. | 12 months | Assess patient satisfaction with the digital tool. |
| The tool's usability will be evaluated using the 10-item System Usability Scale (SUS) (0 to 100). | 12 months | Evaluate the usability of the digital device. |
Countries
France
Contacts
CONTACTLaure Morisset
PRINCIPAL_INVESTIGATORCindy JAFFRY
Versailles Hospital
Outcome results
None listed