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

NCT06082804 | Recruiting

• 1 other identifier: IPA-LMC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Advanced Practice Nursing; Quality of life; Adverse event

Outcome Measures

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

  Inclusion and 6 months

Secondary Outcomes (8)

• 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).

  6 months and 12 months

• Assessment of patient's quality of life

  Inclusion, 6 months and 12 months

• Assessment of patient's compliance to treatment

  6 months and 12 months

• Grade > II adverse events rates

  6 months and 12 months

• Hospitalization rate

  6 months and 12 months

Study Arms (2)

A: IPA group

EXPERIMENTAL

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

B: Control group

ACTIVE COMPARATOR

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

Interventions

APN and medical management OTHER

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

A: IPA group

Medical management OTHER

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

B: Control group

Quality of life assessment BEHAVIORAL

EORTC-QLQ-C30 questionnaire

A: IPA group; B: Control group

Treatment compliance assessment BEHAVIORAL

GIRERD questionnaire

A: IPA group; B: Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old.
• CML patient in chronic phase, eligible for oral therapy.
• Newly diagnosed CML and/or initiating oral therapy :
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Henri Duffaut - Avignon: lead

Study Sites (1)

Centre Hospitalier d'Avignon, Hôpital Henri Duffaut

Avignon, France

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Chronic-Phase

Interventions

Practice Management, Medical

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Practice Management; Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Christine Tosello, APN

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marilyne Grinand, PhD

CONTACT

(+33)432759392; grinand.marilyne@ch-avignon.fr

Christine Tosello, APN

CONTACT

(+33)432759348; ihuel.christine@ch-avignon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 60 patients will be included, these patients will be randomized into two groups.

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 13, 2023
• Study Start: November 29, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

FR (1)