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

Chronic Myelogenous Leukemia - Chronic Phase Clinical Trial

— IPA-LMC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06082804
• Other study ID #: IPA-LMC
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2023
• Est. completion date: December 2027

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Henri Duffaut - Avignon
• Contact: Marilyne Grinand, PhD
• Phone: (+33)432759392
• Email: grinand.marilyne[@]ch-avignon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Myelogenous Leukemia - Chronic Phase
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Chronic-Phase

Intervention

Other:
• APN and medical management
Patients are followed by the advanced practice nurse and the hematologist.
• Medical management
Patients are followed by the hematologist only (standard of care).

Behavioral:
• Quality of life assessment
EORTC-QLQ-C30 questionnaire
• Treatment compliance assessment
GIRERD questionnaire

Locations

Country	Name	City	State
France	Centre Hospitalier d'Avignon, Hôpital Henri Duffaut	Avignon	Provence-Alpes-Côte d'Azur

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Henri Duffaut - Avignon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Grade > II adverse events rates		6 months and 12 months
Secondary	Hospitalization rate		6 months and 12 months
Secondary	Treatment discontinuation rate and/or treatment change rate		Every medical consultation, from inclusion to 12 months
Secondary	Consultation time comparison between advanced practice nurse and hematologist		Every medical consultation, from inclusion to 12 months
Secondary	Molecular response rate assessment		6 months and 12 months