Clinical trial NCT06082804: Evaluation of Advanced Practice Nurse's Management of Patients with Chronic Myeloid Leukemia
Official title: Evaluation of Advanced Practice Nurse's Management of Patients with Chronic Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Myelogenous Leukemia - Chronic Phase
Keywords: Advanced Practice Nursing
Quality of life
Adverse event
Lead sponsor: Centre Hospitalier Henri Duffaut - Avignon
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 60 patients will be included, these patients will be randomized into two groups.
Primary purpose: SUPPORTIVE_CARE

Brief 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 criteria: 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.

Primary outcomes:
measure: 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).
timeFrame: Inclusion and 6 months
Secondary outcomes:
measure: 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).
timeFrame: 6 months and 12 months
measure: Assessment of patient's quality of life
timeFrame: Inclusion, 6 months and 12 months
measure: Assessment of patient's compliance to treatment
timeFrame: 6 months and 12 months
measure: Grade > II adverse events rates
timeFrame: 6 months and 12 months
measure: Hospitalization rate
timeFrame: 6 months and 12 months
measure: Treatment discontinuation rate and/or treatment change rate
timeFrame: Every medical consultation, from inclusion to 12 months
measure: Consultation time comparison between advanced practice nurse and hematologist
timeFrame: Every medical consultation, from inclusion to 12 months
measure: Molecular response rate assessment
timeFrame: 6 months and 12 months
Other outcomes:
Locations:
city: Avignon
country: France
facility: Centre Hospitalier d'Avignon, Hôpital Henri Duffaut
Study officials:
affiliation: Centre Hospitalier d'Avignon, Service d'Oncologie Médicale-Hématologie Clinique
name: Christine Tosello, APN
role: PRINCIPAL_INVESTIGATOR
References: