An interventional study of APN and medical management and Medical management in Chronic Myelogenous Leukemia - Chronic Phase, sponsored by Centre Hospitalier Henri Duffaut - Avignon. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by Centre Hospitalier Henri Duffaut - Avignon · Not applicable, Interventional, and Supportive care
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.
439 studies on the registry are indexed under Leukemia, Myeloid, Chronic-Phase; 27 are open to participants now.
This study's planned enrollment of 60 is above the median of 43 across 322 interventional studies indexed under Leukemia, Myeloid, Chronic-Phase.
Browse Leukemia, Myeloid, Chronic-Phase studies →Centre Hospitalier Henri Duffaut - Avignon is the lead sponsor of 10 studies on the registry; 5 are open to participants now.
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Newly diagnosed CML and/or initiating oral therapy :
Exclusion Criteria:
Patients in arm A are followed by the advanced practice nurse and the hematologist.
Other: APN and medical management · Behavioral: Quality of life assessment · Behavioral: Treatment compliance assessment
Patients in arm B are followed by the hematologist only (standard of care).
Other: Medical management · Behavioral: Quality of life assessment · Behavioral: Treatment compliance assessment
Patients are followed by the advanced practice nurse and the hematologist.
Patients are followed by the hematologist only (standard of care).
EORTC-QLQ-C30 questionnaire
GIRERD questionnaire
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
Time frame: Inclusion and 6 months
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
Time frame: 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).
Time frame: 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).
Time frame: 6 months and 12 months
Grade > II adverse events rates
Time frame: 6 months and 12 months
Hospitalization rate
Time frame: 6 months and 12 months
Treatment discontinuation rate and/or treatment change rate
Time frame: Every medical consultation, from inclusion to 12 months
Consultation time comparison between advanced practice nurse and hematologist
Time frame: Every medical consultation, from inclusion to 12 months
Molecular response rate assessment
Time frame: 6 months and 12 months
Started Nov 2023 (actual). Primary completion is estimated for Jun 2027, 43 months after the start.
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Leukemia, Myeloid, Chronic-Phase →
Centre Hospitalier Henri Duffaut - Avignon