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

RecruitingNAAges 18 Years - anyAllCentre Hospitalier Henri Duffaut - Avignon
NCT06082804 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years old. * CML patient in chronic phase, eligible for oral therapy. * Newly diagnosed CML and/or initiating oral therapy : * Patient changing treatment for non-response or loss of therapeutic response or toxicities, on the condition that these toxicities are resolved or grade I maximum at the time of inclusion. * Newly start of oral therapy. * Patient eligible to a follow-up by an advanced practice nurse. * Patient capable to understand french and complete a questionnaire. Exclusion Criteria: * Patient that had a follow-up \> 3 months by an advanced practice nurse for CML before inclusion. * Patient changing treatment for toxicities, if these toxicities are still \> grade I at inclusion. * Patient enrolled in another interventional research protocol for CML. * Pregnant women. * Patient under legal protection, deprived of liberty or unable to be included in a research protocol.
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What it tests

  • APN and medical management
  • Medical management
  • Quality of life assessment
  • Treatment compliance assessment
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Where

1 site
Centre Hospitalier d'Avignon, Hôpital Henri Duffaut
Avignon, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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