Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Centre Hospitalier d'Avignon, Hôpital Henri Duffaut
Avignon, France
Actively Recruiting
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
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