Evaluation of Advanced Practice Nurse's Management of Patients With Chronic Myeloid Leukemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Henri Duffaut - Avignon
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years old.
CML patient in chronic phase, eligible for 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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
APN and medical management
Other interventionPatients are followed by the advanced practice nurse and the hematologist.
Medical management
Other interventionPatients are followed by the hematologist only (standard of care).
Quality of life assessment
BehavioralEORTC-QLQ-C30 questionnaire
Treatment compliance assessment
BehavioralGIRERD questionnaire
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: A: IPA groupExperimental treatment 3 interventions
Group B: B: Control groupActive comparator 3 interventions
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
Grade > II adverse events rates
Time frame
6 months and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov