Feasibility Study to Evaluate a Digital Tool for Monitoring Patients Who Have Discontinued Treatment for Chronic Myeloid Leukemia

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVersailles Hospital

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Integration of a digital tool

    Other intervention

    Integration 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

20 Participants
are divided into 1 treatment group
Group A: Intervention armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
12 months

Secondary outcomes

1

Number of times patients used the device.

Assess how often the device is used.

Time frame
12 months
2

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.

Time frame
12 months
3

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

Time frame
12 months
4

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: