Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT05309018
Status:
WITHDRAWN
Last Update Posted:
2024-05-23
First Post:
2022-03-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Implantation of an Advanced Practice Nurse in the Complex Care Pathway of Patients With AML
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': "investigator's unavailability", 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-05-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-22', 'studyFirstSubmitDate': '2022-03-25', 'studyFirstSubmitQcDate': '2022-03-25', 'lastUpdatePostDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perception of patient', 'timeFrame': 'Within 1 month', 'description': 'Semi-structured interview about perceptions and expectations of Advanced Practice Nurse (APN) participation in acute myeloid leukemia (AML) monitoring according to patient.'}], 'secondaryOutcomes': [{'measure': 'Perception of care team', 'timeFrame': 'Within 1 month', 'description': 'Semi-structured interview about perceptions and expectations of Advanced Practice Nurse (APN) participation in acute myeloid leukemia (AML) monitoring according to care team.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced Practice Nurse', 'Acute Myeloid Leukemia,'], 'conditions': ['Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with MLA Care team', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with AML\n* Treated with a new targeted oral therapy as monotherapy or in combination:\n\n * Venetoclax\\* in combination with ivosidenib (IDH1 inhibitor)\n * Onureg\\* (azacitin: pyrimidine analogue)\n * Venetoclax (BCL-2 protein inhibitor) in combination with subcutaneous azacitin\n* Whose follow-up is provided alternately by a hematologist and an IPA.\n* Affiliated to a social security scheme\n\nExclusion Criteria:\n\n* Moderate or severe cognitive impairment\n* Language barrier\n* Other communication disorders'}, 'identificationModule': {'nctId': 'NCT05309018', 'acronym': 'LAMIPA', 'briefTitle': 'Implantation of an Advanced Practice Nurse in the Complex Care Pathway of Patients With AML', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Régional Metz-Thionville'}, 'officialTitle': 'Implantation of an Advanced Practice Nurse in the Complex Care Pathway of Patients Followed for AML Treated With Oral Targeted Therapy', 'orgStudyIdInfo': {'id': '2021-07Obs-CHRMT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'interventionNames': ['Other: Interviews']}, {'label': 'medical staff', 'interventionNames': ['Other: Interviews']}], 'interventions': [{'name': 'Interviews', 'type': 'OTHER', 'description': 'Semi-structured interview about perceptions and expectations of APN participation in AML monitoring according to patient and to care team.', 'armGroupLabels': ['Patients', 'medical staff']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jennifer HUET', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHR Metz Thionville Hopital de Mercy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Régional Metz-Thionville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}