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

NCT ID: NCT06082804

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-29
• Study Completion Date: 2027-12-31

Brief 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.

Conditions

Chronic Myelogenous Leukemia - Chronic Phase

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

A: IPA group

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

Group Type: EXPERIMENTAL

APN and medical management

Intervention Type: OTHER

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

Quality of life assessment

Intervention Type: BEHAVIORAL

EORTC-QLQ-C30 questionnaire

Treatment compliance assessment

Intervention Type: BEHAVIORAL

GIRERD questionnaire

B: Control group

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

Group Type: ACTIVE_COMPARATOR

Medical management

Intervention Type: OTHER

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

Quality of life assessment

Intervention Type: BEHAVIORAL

EORTC-QLQ-C30 questionnaire

Treatment compliance assessment

Intervention Type: BEHAVIORAL

GIRERD questionnaire

Interventions

APN and medical management

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

Intervention Type: OTHER

Medical management

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

Intervention Type: OTHER

Quality of life assessment

EORTC-QLQ-C30 questionnaire

Intervention Type: BEHAVIORAL

Treatment compliance assessment

GIRERD questionnaire

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Henri Duffaut - Avignon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Tosello, APN

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier d'Avignon, Service d'Oncologie Médicale-Hématologie Clinique

Locations

Centre Hospitalier d'Avignon, Hôpital Henri Duffaut

Avignon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Marilyne Grinand, PhD

Role: CONTACT

grinand.marilyne@ch-avignon.fr

(+33)432759392

Christine Tosello, APN

Role: CONTACT

ihuel.christine@ch-avignon.fr

(+33)432759348

Facility Contacts

Marilyne Grinand, PhD

Role: primary

grinand.marilyne@ch-avignon.fr

(+33)432759392

Christine Tosello, APN

Role: backup

Borhane Slama, MD

Role: backup

Hacène Zerazhi, MD

Role: backup

Safia Chebrek, MD

Role: backup

Thierry Takam, MD

Role: backup

Other Identifiers

IPA-LMC

Identifier Type: -

Identifier Source: org_study_id