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

NCT05309018 | Withdrawn

• 1 other identifier: 2021-07Obs-CHRMT
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Myeloid Leukemia

Keywords

Advanced Practice Nurse; Acute Myeloid Leukemia,

Outcome Measures

Primary Outcomes (1)

• Perception of patient

  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 Outcomes (1)

• Perception of care team

  Within 1 month

Study Arms (2)

Patients

Other: Interviews

medical staff

Other: Interviews

Interventions

Interviews OTHER

Semi-structured interview about perceptions and expectations of APN participation in AML monitoring according to patient and to care team.

Patients; medical staff

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with MLA Care team

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

MeSH Terms

Conditions

Leukemia, Myeloid; Leukemia, Myeloid, Acute

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jennifer HUET

  CHR Metz Thionville Hopital de Mercy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 4, 2022
• Study Start: May 15, 2024
• Primary Completion: August 15, 2024
• Study Completion: December 15, 2024
• Last Updated: May 23, 2024

Record last verified: 2024-05