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Trial Title:
Evaluation of Advanced Practice Nurse's Management of Patients With Chronic Myeloid Leukemia
NCT ID:
NCT06082804
Condition:
Chronic Myelogenous Leukemia - Chronic Phase
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Conditions: Keywords:
Advanced Practice Nursing
Quality of life
Adverse event
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
60 patients will be included, these patients will be randomized into two groups.
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
APN and medical management
Description:
Patients are followed by the advanced practice nurse and the hematologist.
Arm group label:
A: IPA group
Intervention type:
Other
Intervention name:
Medical management
Description:
Patients are followed by the hematologist only (standard of care).
Arm group label:
B: Control group
Intervention type:
Behavioral
Intervention name:
Quality of life assessment
Description:
EORTC-QLQ-C30 questionnaire
Arm group label:
A: IPA group
Arm group label:
B: Control group
Intervention type:
Behavioral
Intervention name:
Treatment compliance assessment
Description:
GIRERD questionnaire
Arm group label:
A: IPA group
Arm group label:
B: Control group
Summary:
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Hospitalier d'Avignon, Hôpital Henri Duffaut
Address:
City:
Avignon
Country:
France
Status:
Recruiting
Contact:
Last name:
Marilyne Grinand, PhD
Phone:
(+33)432759392
Email:
grinand.marilyne@ch-avignon.fr
Investigator:
Last name:
Christine Tosello, APN
Email:
Principal Investigator
Investigator:
Last name:
Borhane Slama, MD
Email:
Sub-Investigator
Investigator:
Last name:
Hacène Zerazhi, MD
Email:
Sub-Investigator
Investigator:
Last name:
Safia Chebrek, MD
Email:
Sub-Investigator
Investigator:
Last name:
Thierry Takam, MD
Email:
Sub-Investigator
Start date:
November 29, 2023
Completion date:
December 2027
Lead sponsor:
Agency:
Centre Hospitalier Henri Duffaut - Avignon
Agency class:
Other
Source:
Centre Hospitalier Henri Duffaut - Avignon
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06082804
