Evaluation of Advanced Practice Nurse's Management of Patients With Chronic Myeloid Leukemia (IPA-LMC)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Myelogenous Leukemia - Chronic Phase
• Intervention / Treatment: Other: APN and medical management; Behavioral: Treatment compliance assessment; Other: Medical management; Behavioral: Quality of life assessment

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marilyne Grinand, PhD; Phone Number: (+33)432759392; Email: grinand.marilyne@ch-avignon.fr
• Study Contact Backup: Name: Christine Tosello, APN; Phone Number: (+33)432759348; Email: ihuel.christine@ch-avignon.fr

Study Locations

• France
  • Provence-Alpes-Côte d'Azur
    • Avignon, Provence-Alpes-Côte d'Azur, France
      • Recruiting
      • Centre Hospitalier d'Avignon, Hôpital Henri Duffaut
      • Contact: Marilyne Grinand, PhD; Phone Number: (+33)432759392; Email: grinand.marilyne@ch-avignon.fr
      • Principal Investigator: Christine Tosello, APN
      • Sub-Investigator: Borhane Slama, MD
      • Sub-Investigator: Hacène Zerazhi, MD
      • Sub-Investigator: Safia Chebrek, MD
      • Sub-Investigator: Thierry Takam, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A: IPA group; Patients in arm A are followed by the advanced practice nurse and the hematologist.	Other: APN and medical management; Patients are followed by the advanced practice nurse and the hematologist.; Behavioral: Treatment compliance assessment; GIRERD questionnaire; Behavioral: Quality of life assessment; EORTC-QLQ-C30 questionnaire
Active Comparator: B: Control group; Patients in arm B are followed by the hematologist only (standard of care).	Behavioral: Treatment compliance assessment; GIRERD questionnaire; Other: Medical management; Patients are followed by the hematologist only (standard of care).; Behavioral: Quality of life assessment; EORTC-QLQ-C30 questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Henri Duffaut - Avignon
• Investigators: Principal Investigator: Christine Tosello, APN, Centre Hospitalier d'Avignon, Service d'Oncologie Médicale-Hématologie Clinique

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: October 9, 2023
• First Submitted That Met QC Criteria: October 9, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Quality of life; Adverse event; Advanced Practice Nursing
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Disease Attributes; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Chronic Disease; Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase
• Other Study ID Numbers: IPA-LMC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No