NCT07760311

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
25mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

September 15, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 7, 2026

Last Update Submit

August 7, 2026

Conditions

Chronic Leukemia

Outcome Measures

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

    12 months

Secondary Outcomes (7)

  • Number of times patients used the device.

    12 months

  • 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

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

    12 months

  • 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

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

    12 months

  • +2 more secondary outcomes

Study Arms (1)

Intervention arm

EXPERIMENTAL

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

Integration of a digital toolOTHER

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

Intervention arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CH de Versailles

Le Chesnay, 78150, France

Location

Study Officials

  • Cindy JAFFRY

    Versailles Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laure Morisset

CONTACT

+33139239785lmorisset@ght78sud.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 7, 2026

First Posted

August 12, 2026

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2028

Last Updated

August 12, 2026

Record last verified: 2026-08

Locations

FR(1)