Evaluation of Advanced Practice Nurse's Management of Patients with Chronic Myeloid Leukemia (IPA-LMC)

Centre Hospitalier Henri Duffaut - Avignon

Status: Enrolling

Conditions: Chronic Myelogenous Leukemia - Chronic Phase

Treatments: Behavioral: Treatment compliance assessment; Other: Medical management; Behavioral: Quality of life assessment; Other: APN and medical management

Study type: Interventional

Funder types: Other

Identifiers

NCT06082804

IPA-LMC

Details and patient eligibility

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

A: IPA group

Experimental group

Description:

Patients in arm A are followed by the advanced practice nurse and the hematologist.

Treatment:

Other: APN and medical management

Behavioral: Quality of life assessment

Behavioral: Treatment compliance assessment

B: Control group

Active Comparator group

Description:

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

Treatment:

Behavioral: Quality of life assessment

Other: Medical management

Behavioral: Treatment compliance assessment