About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Integration of a digital tool
Other interventionIntegration of a digital tool into the follow-up care of patients with CML who have been off treatment for up to 2 years.
Treatment groups
Trial outcomes
Primary outcomes
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.
To evaluate, over a 12-month period, the feasibility of integrating a digital tool into the care of patients with chronic myeloid leukemia
Secondary outcomes
Number of times patients used the device.
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.
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.
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).
To study anxiety symptoms and their progression over the course of follow-up.
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: