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

Обзор

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.

Вмешательства

• Другое APN and medical management
  Patients are followed by the advanced practice nurse and the hematologist.
• Другое Medical management
  Patients are followed by the hematologist only (standard of care).
• Поведенческое Quality of life assessment
  EORTC-QLQ-C30 questionnaire
• Поведенческое Treatment compliance assessment
  GIRERD questionnaire

Первичные конечные точки

• Evaluate the role of the advanced practice nurse in early detection of grade I-II adverse events during care and management of Chronic Myeloid Leukemia compared to standard of care (hematologist only). [Срок оценки: Inclusion and 6 months]

Вторичные конечные точки (8)

• Evaluate the role of the advanced practice nurse in early detection of grade I-II adverse events during care and management of Chronic Myeloid Leukemia compared to standard of care (hematologist only). [Срок оценки: 6 months and 12 months]
• Assessment of patient's quality of life [Срок оценки: Inclusion, 6 months and 12 months]
• Assessment of patient's compliance to treatment [Срок оценки: 6 months and 12 months]
• Grade > II adverse events rates [Срок оценки: 6 months and 12 months]
• Hospitalization rate [Срок оценки: 6 months and 12 months]
• Treatment discontinuation rate and/or treatment change rate [Срок оценки: Every medical consultation, from inclusion to 12 months]
• Consultation time comparison between advanced practice nurse and hematologist [Срок оценки: Every medical consultation, from inclusion to 12 months]
• Molecular response rate assessment [Срок оценки: 6 months and 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Centre Hospitalier d'Avignon, Hôpital Henri Duffaut — Avignon

Идентификаторы

NCT: NCT06082804 · IPA-LMC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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