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Not yet recruitingNCT07760311FREE CMLUpdated Aug 12, 2026

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

An interventional study of Integration of a digital tool in Chronic Leukemia, sponsored by Versailles Hospital. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Versailles Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Chronic Leukemia
03

In context

Lead sponsor

Versailles Hospital is the lead sponsor of 74 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Intervention arm

    Integration of a digital tool into the follow-up care of patients with CML who have been off treatment for up to 2 years.

    Other: Integration of a digital tool

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.

06

What researchers measure

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

  5. Changes in the GAD-7 anxiety score (0 to 21) based on the duration of treatment interruption (months) and the frequence

    To examine the relationship between changes in anxiety scores based on the duration of treatment interruption and the use of the device.

    Time frame: 12 months

  6. 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.

    Assess patient satisfaction with the digital tool.

    Time frame: 12 months

  7. The tool's usability will be evaluated using the 10-item System Usability Scale (SUS) (0 to 100).

    Evaluate the usability of the digital device.

    Time frame: 12 months

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07760311
Lead sponsor
Versailles Hospital
Responsible party
Cindy JAFFRY (Principal investigator, Versailles Hospital) — Principal investigator
First posted
Aug 12, 2026
Start date
Sep 15, 2026 (estimated)
Primary completion
Sep 30, 2027 (estimated)
Completion
Sep 30, 2028 (estimated)
Last update
Aug 12, 2026

Study contacts

Laure Morisset
Contact
lmorisset@ght78sud.fr
+33139239785
Cindy JAFFRY
principal investigator · Versailles Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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