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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05309018
Other study ID # 2021-07Obs-CHRMT
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 15, 2024
Est. completion date December 15, 2024

Study information

Verified date February 2023
Source Centre Hospitalier Régional Metz-Thionville
Contact Jennifer HUET
Phone 0033387553304
Email jennifer.huet@hotmail.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 35
Est. completion date December 15, 2024
Est. primary completion date August 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Régional Metz-Thionville

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Perception of care team 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
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