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Evaluation of Advanced Practice Nurse's Management of Patients With Chronic Myeloid Leukemia

NCT06082804 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-04

No results posted yet for this study

Summary

Chronic Myeloid Leukemia (CML) affects 820 people per year in France (2018), half of them are older than 60 years old.

Tyrosine Kinase Inhibitors (TKI) are new kind of targeted therapy whose efficiency allow for a high rate of complete molecular response, leading to a disruption of treatment under certain conditions.

Optimizing CML treatment is a major concern, particularly for adverse events management, treatment compliance and therapeutic response. Multiple studies demonstrated that grade ≤ II adverse events are most likely to be under reported by patients and clinicians. Although these adverse events are mostly reported by clinical examination, needing minimal treatment. These toxicities could alter daily and domestic living activities, potentially impacting treatment compliance and therapeutic response. Therefore, early detection of these adverse events is a major challenge for the prognosis and care of CML.

The Advanced Practice Nurse (APN), a new health care professional, acquired the skills needed to independently follow, manage and care the patients with medical approvals.

At international level, many studies, in oncology and in others domains, have been done to demonstrate the added value of the APN, particularly in improving patient's quality of life, management, care of drug-induced adverse events and treatment compliance.

In France, because of the recentness of the profession, only few studies were have been conducted. The goal of this study is to demonstrate the benefit of APN in clinical follow-up, quality of life, treatment compliance, and therapeutic response of CML patients. These effects could be managed thanks to early detection and management of ≤ grade II adverse events during consultation, in partnership with the patients, and in collaborative working.

Conditions

  • Chronic Myelogenous Leukemia - Chronic Phase

Interventions

OTHER

APN and medical management

Patients are followed by the advanced practice nurse and the hematologist.

OTHER

Medical management

Patients are followed by the hematologist only (standard of care).

BEHAVIORAL

Quality of life assessment

EORTC-QLQ-C30 questionnaire

BEHAVIORAL

Treatment compliance assessment

GIRERD questionnaire

Sponsors & Collaborators

  • Centre Hospitalier Henri Duffaut - Avignon

    lead OTHER

Principal Investigators

  • Christine Tosello, APN · Centre Hospitalier d'Avignon, Service d'Oncologie Médicale-Hématologie Clinique

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-29
Primary Completion
2027-06-30
Completion
2027-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06082804 on ClinicalTrials.gov