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NCT Number: NCT07760311

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

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.

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Key information

Conditions

Chronic Leukemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Integration of a digital tool

Other

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

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.

    Time frame: 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 outcomes

  1. Number of times patients used the device.

    Time frame: 12 months

    Assess how often the device is used.

  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.

    Time frame: 12 months

    Assess the time it takes for the Study Nurse and the patient to access laboratory results.

  3. The frequency with which patients contact the study nurse through the system's communication module.

    Time frame: 12 months

    Evaluate the use of the digital device's data exchange module between the patient and the Study Nurse

  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).

    Time frame: 12 months

    To study anxiety symptoms and their progression over the course of follow-up.

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

    Time frame: 12 months

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

  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.

    Time frame: 12 months

    Assess patient satisfaction with the digital tool.

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

    Time frame: 12 months

    Evaluate the usability of the digital device.

Study contacts

Contact information is provided by the study sponsor or research team.

Laure Morisset

CONTACT

[email protected]

+33139239785

Sponsors and collaborators

Lead sponsor

Versailles Hospital

Other

Registry information

Acronym: FREE CML

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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