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NCT Number: NCT06082804

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier d'Avignon, Hôpital Henri Duffaut

Avignon, France

Location status: Recruiting

Location contact

Borhane Slama, MD

SUB_INVESTIGATOR

Christine Tosello, APN

PRINCIPAL_INVESTIGATOR

Hacène Zerazhi, MD

SUB_INVESTIGATOR

Marilyne Grinand, PhD

CONTACT

[email protected]

(+33)432759392

Safia Chebrek, MD

SUB_INVESTIGATOR

Thierry Takam, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

APN and medical management

Other

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

Medical management

Other

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

Quality of life assessment

Behavioral

EORTC-QLQ-C30 questionnaire

Treatment compliance assessment

Behavioral

GIRERD questionnaire

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).

    Time frame: Inclusion and 6 months

    Grade I-II adverse events rate

Secondary 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).

    Time frame: 6 months and 12 months

    Grade I-II adverse events rate

  2. Assessment of patient's quality of life

    Time frame: Inclusion, 6 months and 12 months

    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).

  3. Assessment of patient's compliance to treatment

    Time frame: 6 months and 12 months

    GIRERD questionnaire (measures range from 0 to 6. A low score represents a high level of compliance).

  4. Grade > II adverse events rates

    Time frame: 6 months and 12 months

  5. Hospitalization rate

    Time frame: 6 months and 12 months

  6. Treatment discontinuation rate and/or treatment change rate

    Time frame: Every medical consultation, from inclusion to 12 months

  7. Consultation time comparison between advanced practice nurse and hematologist

    Time frame: Every medical consultation, from inclusion to 12 months

  8. Molecular response rate assessment

    Time frame: 6 months and 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Tosello, APN

CONTACT

[email protected]

(+33)432759348

Marilyne Grinand, PhD

CONTACT

[email protected]

(+33)432759392

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Henri Duffaut - Avignon

Other

Registry information

Acronym: IPA-LMC

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 13, 2023
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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