RecruitingNot ApplicableNCT06082804

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


Sponsor

Centre Hospitalier Henri Duffaut - Avignon

Enrollment

60 participants

Start Date

Nov 29, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates whether specialized cancer nurse practitioners can effectively manage patients with chronic myeloid leukemia (CML), a type of blood cancer treated with oral medications. The goal is to see if nurse-led care (with physician oversight) achieves the same outcomes as traditional doctor-led care. **You may be eligible if...** - You are 18 or older and have been diagnosed with CML in the chronic phase - You are newly starting oral therapy for CML, OR switching medications due to side effects or treatment failure - You are able to read French and fill out questionnaires - You are eligible for follow-up by an advanced practice nurse **You may NOT be eligible if...** - You have already been followed by an advanced practice nurse for CML for more than 3 months before the study - You are switching treatment due to side effects that are still severe (above grade 1) - You are enrolled in another CML interventional research study - You are pregnant - You are under legal protection or unable to provide consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERAPN and medical management

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

OTHERMedical management

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

BEHAVIORALQuality of life assessment

EORTC-QLQ-C30 questionnaire

BEHAVIORALTreatment compliance assessment

GIRERD questionnaire


Locations(1)

Centre Hospitalier d'Avignon, Hôpital Henri Duffaut

Avignon, France

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NCT06082804


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