Chronic Myelogenous Leukemia - Chronic PhaseIPA-LMCNCT06082804
Evaluation of Advanced Practice Nurse's Management of Patients With Chronic Myeloid Leukemia
A study testing APN and medical management, Medical management and Quality of life assessment in people with Chronic Myelogenous Leukemia - Chronic Phase, run by Centre Hospitalier Henri Duffaut - Avignon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myelogenous Leukemia - Chronic Phase
- What is being tested?
- APN and medical management, Medical management and Quality of life assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 29 Nov 2023to Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier d'Avignon, Hôpital Henri Duffaut
Avignon
Marilyne Grinand, PhD, (+33)432759392, grinand.marilyne@ch-avignon.fr
Christine Tosello, APN
About this study
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.
Read more
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.
- Being tested
- APN and medical management, Medical management, Quality of life assessment, Treatment compliance assessment
- Keywords
- Advanced Practice Nursing, Quality of life, Adverse event
- Medical subject headings
- Leukemia, Myeloid, Chronic-Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APN and medical managementOther
Patients are followed by the advanced practice nurse and the hematologist.
Medical managementOther
Patients are followed by the hematologist only (standard of care).
Quality of life assessmentBehavioural
EORTC-QLQ-C30 questionnaire
Treatment compliance assessmentBehavioural
GIRERD questionnaire
| Study group | Role | What they receive |
|---|---|---|
| A: IPA group | Experimental | Patients in arm A are followed by the advanced practice nurse and the hematologist. Receives: 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). Receives: Other: Medical management; Behavioral: Quality of life assessment; Behavioral: Treatment compliance assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Grade I-II adverse events rate
Measured: 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).
Measured: 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).
Measured: 6 months and 12 months
Grade > II adverse events rates
Measured: 6 months and 12 months
Hospitalization rate
Measured: 6 months and 12 months
Treatment discontinuation rate and/or treatment change rate
Measured: Every medical consultation, from inclusion to 12 months
Consultation time comparison between advanced practice nurse and hematologist
Measured: Every medical consultation, from inclusion to 12 months
Molecular response rate assessment
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start29 Nov 2023
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myelogenous Leukemia - Chronic PhaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 60 patients will be included, these patients will be randomized into two groups.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Henri Duffaut - Avignon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Tosello, APN, Principal investigator, Centre Hospitalier d'Avignon, Service d'Oncologie Médicale-Hématologie Clinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082804
- Sponsor's protocol ID
- IPA-LMC
- Acronym
- IPA-LMC
- Status last verified
- Mar 2026
- First submitted
- 9 Oct 2023
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No