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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Myelogenous Leukemia - Chronic Phase

Intervention / Treatment
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* Other: APN and medical management
* Other: Medical management
* Behavioral: Quality of life assessment
* Behavioral: Treatment compliance assessment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 60 patients will be included, these patients will be randomized into two groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A: IPA group<br>Patients in arm A are followed by the advanced practice nurse and the hematologist. | Other: APN and medical management<br>* Patients are followed by the advanced practice nurse and the hematologist.<br>Behavioral: Quality of life assessment<br>* EORTC-QLQ-C30 questionnaire<br>Behavioral: Treatment compliance assessment<br>* GIRERD questionnaire<br>|
| Active Comparator: B: Control group<br>Patients in arm B are followed by the hematologist only (standard of care). | Other: Medical management<br>* Patients are followed by the hematologist only (standard of care).<br>Behavioral: Quality of life assessment<br>* EORTC-QLQ-C30 questionnaire<br>Behavioral: Treatment compliance assessment<br>* GIRERD questionnaire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Grade I-II adverse events rate | Inclusion and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Grade I-II adverse events rate | 6 months and 12 months | 
| Assessment of patient's quality of life | European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Core-30 : EORTC-QLQ-C30 (composed of both multi-item scales and single-item measures : 5 functional scales, 3 symptom scales, 6 single items and a global health status. All of the the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. ie : A high score for a functional scale represents a high level of functioning, a high score for the global health status represents a high quality of life but a high score for a symptom scale or a single item represents a high level of symptomatology). | Inclusion, 6 months and 12 months | 
| Assessment of patient's compliance to treatment | GIRERD questionnaire (measures range from 0 to 6. A low score represents a high level of compliance). | 6 months and 12 months | 
| Grade > II adverse events rates |  | 6 months and 12 months | 
| Hospitalization rate |  | 6 months and 12 months | 
| Treatment discontinuation rate and/or treatment change rate |  | Every medical consultation, from inclusion to 12 months | 
| Consultation time comparison between advanced practice nurse and hematologist |  | Every medical consultation, from inclusion to 12 months | 
| Molecular response rate assessment |  | 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Practice Nursing, Quality of life, Adverse event