Implantation of an Advanced Practice Nurse in the Complex Care Pathway of Patients With AML (LAMIPA)

May 22, 2024 updated by: Centre Hospitalier Régional Metz-Thionville

Implantation of an Advanced Practice Nurse in the Complex Care Pathway of Patients Followed for AML Treated With Oral Targeted Therapy

Advanced Practice Nurse (APN) is a new contributor in the French healthcare system. APN is part of a multidisciplinary team and aim to monitor patients under the coordination of the doctor particularly in onco-hematology. The aim of the study is to describe the different perceptions and expectations of APN monitoring according to patients with acute myeloid leukemia (AML) and their care team.

This study will involve 10 patients, recruited over a provisional period of 5 months and 25 member of care team. Patients and their care team will be asked about their perceptions and expectations of APN participation in (AML monitoring) during a semi-structured interviews.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient with MLA Care team

Description

Inclusion Criteria:

  • Patient with AML

  • Treated with a new targeted oral therapy as monotherapy or in combination:

    • Venetoclax* in combination with ivosidenib (IDH1 inhibitor)
    • Onureg* (azacitin: pyrimidine analogue)
    • Venetoclax (BCL-2 protein inhibitor) in combination with subcutaneous azacitin
  • Whose follow-up is provided alternately by a hematologist and an IPA.
  • Affiliated to a social security scheme

Exclusion Criteria:

  • Moderate or severe cognitive impairment
  • Language barrier
  • Other communication disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Other: Interviews
Semi-structured interview about perceptions and expectations of APN participation in AML monitoring according to patient and to care team.
medical staff
Other: Interviews
Semi-structured interview about perceptions and expectations of APN participation in AML monitoring according to patient and to care team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perception of patient
Time Frame: Within 1 month
Semi-structured interview about perceptions and expectations of Advanced Practice Nurse (APN) participation in acute myeloid leukemia (AML) monitoring according to patient.
Within 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perception of care team
Time Frame: Within 1 month
Semi-structured interview about perceptions and expectations of Advanced Practice Nurse (APN) participation in acute myeloid leukemia (AML) monitoring according to care team.
Within 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional Metz-Thionville

Investigators

  • Principal Investigator: Jennifer HUET, CHR Metz Thionville Hopital de Mercy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2024

Primary Completion (Estimated)

August 15, 2024

Study Completion (Estimated)

December 15, 2024

Study Registration Dates

First Submitted

March 25, 2022

First Submitted That Met QC Criteria

March 25, 2022

First Posted (Actual)

April 4, 2022

Study Record Updates

Last Update Posted (Actual)

May 23, 2024

Last Update Submitted That Met QC Criteria

May 22, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-07Obs-CHRMT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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