Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06082804

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

Led by Centre Hospitalier Henri Duffaut - Avignon · Updated on 2026-03-04

60

Participants Needed

1

Research Sites

209 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 218 years or older
  • Diagnosis of Chronic Myeloid Leukemia in chronic phase, eligible for oral therapy
  • Newly diagnosed or initiating oral therapy, including patients changing treatment for non-response, loss of response, or toxicities if resolved or grade I at inclusion
  • Eligible for follow-up by an advanced practice nurse
  • Able to understand French and complete questionnaires
Not Eligible

You will not qualify if you...

  • Follow-up by an advanced practice nurse for CML for more than 3 months before inclusion
  • Changing treatment for toxicities that are still above grade I at inclusion
  • Enrolled in another interventional research protocol for CML
  • Pregnant women
  • Under legal protection, deprived of liberty, or unable to participate in research

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Centre Hospitalier d'Avignon, Hôpital Henri Duffaut

Avignon, France

Actively Recruiting

Loading map...

Research Team

M

Marilyne Grinand, PhD

CONTACT

C

Christine Tosello, APN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here