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MPN Clinical Trial Finder

Clinical Trial Finder

Search Results

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06082804
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Centre Hospitalier Henri Duffaut - Avignon
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Christine Tosello, APN
Principal Investigator Affiliation Centre Hospitalier d'Avignon, Service d'Oncologie Médicale-Hématologie Clinique
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Chronic Myelogenous Leukemia - Chronic Phase
Arms & Interventions

Arms

Experimental: A: IPA group

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

Active Comparator: B: Control group

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

Interventions

Other: - APN and medical management

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

Other: - Medical management

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

Behavioral: - Quality of life assessment

EORTC-QLQ-C30 questionnaire

Behavioral: - Treatment compliance assessment

GIRERD questionnaire

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Avignon, Provence-Alpes-Côte d'Azur, France

Status

Recruiting

Address

Centre Hospitalier d'Avignon, Hôpital Henri Duffaut

Avignon, Provence-Alpes-Côte d'Azur,

Site Contact

Marilyne Grinand, PhD

[email protected]

(+33)432759392

Nearest Location

Site Contact

Marilyne Grinand, PhD

[email protected]

(+33)432759392

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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