Feasibility Study to Evaluate a Digital Tool for Monitoring Patients Who Have Discontinued Treatment for Chronic Myeloid Leukemia (FREE CML)
7. august 2026 opdateret af: Cindy JAFFRY, Versailles Hospital
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
20
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Laure Morisset
- Telefonnummer: +33139239785
- E-mail: lmorisset@ght78sud.fr
Studiesteder
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-
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Le Chesnay, Frankrig, 78150
- CH de Versailles
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Kontakt:
- Laure MORISSET
- Telefonnummer: 0139239785
- E-mail: lmorisset@ght78sud.fr
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Integration of a digital tool into the follow-up care of patients with CML who have been off treatment for up to 2 years.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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.
Tidsramme: 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
|
12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of times patients used the device.
Tidsramme: 12 months
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Assess how often the device is used.
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12 months
|
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The number of days between when the blood test is performed and when the IPA and the patient view the results on the device.
Tidsramme: 12 months
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Assess the time it takes for the Study Nurse and the patient to access laboratory results.
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12 months
|
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The frequency with which patients contact the study nurse through the system's communication module.
Tidsramme: 12 months
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Evaluate the use of the digital device's data exchange module between the patient and the Study Nurse
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12 months
|
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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).
Tidsramme: 12 months
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To study anxiety symptoms and their progression over the course of follow-up.
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12 months
|
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Changes in the GAD-7 anxiety score (0 to 21) based on the duration of treatment interruption (months) and the frequence
Tidsramme: 12 months
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To examine the relationship between changes in anxiety scores based on the duration of treatment interruption and the use of the device.
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12 months
|
|
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.
Tidsramme: 12 months
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Assess patient satisfaction with the digital tool.
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12 months
|
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The tool's usability will be evaluated using the 10-item System Usability Scale (SUS) (0 to 100).
Tidsramme: 12 months
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Evaluate the usability of the digital device.
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12 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Cindy JAFFRY, Versailles Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
15. september 2026
Primær færdiggørelse (Anslået)
30. september 2027
Studieafslutning (Anslået)
30. september 2028
Datoer for studieregistrering
Først indsendt
7. august 2026
Først indsendt, der opfyldte QC-kriterier
7. august 2026
Først opslået (Faktiske)
12. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- P25/02_FREE CML
- 2025-A02577-42 (Anden identifikator: ID-RCB Number)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .