Neoplasms

Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Behaviors and Mental Disorders

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Leukemia, Myeloid, Chronic-Phase

Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Quality of Life

Myeloid Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

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

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

Patients are followed by the advanced practice nurse and the hematologist.

APN and medical management

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

Medical management

Quality of life assessment

Treatment compliance assessment

Marilyne Grinand, PhD

Christine Tosello, APN

Borhane Slama, MD

Hacène Zerazhi, MD

Safia Chebrek, MD

Thierry Takam, MD

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.

60 patients will be included, these patients will be randomized into two groups.

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

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).

GIRERD questionnaire (measures range from 0 to 6. A low score represents a high level of compliance).

Centre Hospitalier Henri Duffaut - Avignon

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Advanced Practice Nurse's Management of Patients With Chronic Myeloid Leukemia	NCT06082804	Chronic Myeloge...	APN and medical... Medical managem... Quality of life... Treatment compl...	18 Years -	Centre Hospitalier Henri Duffaut - Avignon
Evaluation of Advanced Practice Nurse's Management of Patients With Chronic Myeloid Leukemia	NCT06082804	Chronic Myeloge...	APN and medical... Medical managem... Quality of life... Treatment compl...	18 Years -	Centre Hospitalier Henri Duffaut - Avignon
Evaluation of Advanced Practice Nurse's Management of Patients With Chronic Myeloid Leukemia	NCT06082804	Chronic Myeloge...	APN and medical... Medical managem... Quality of life... Treatment compl...	18 Years -	Centre Hospitalier Henri Duffaut - Avignon
Evaluation of Advanced Practice Nurse's Management of Patients With Chronic Myeloid Leukemia	NCT06082804	Chronic Myeloge...	APN and medical... Medical managem... Quality of life... Treatment compl...	18 Years -	Centre Hospitalier Henri Duffaut - Avignon

Spots Global Cancer Trial Database for treatment compliance assessment