Myeloid LeukemiaLAMIPANCT05309018
Implantation of an Advanced Practice Nurse in the Complex Care Pathway of Patients With AML
An observational study of Myeloid Leukemia, run by Centre Hospitalier Régional Metz-Thionville.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloid Leukemia
- What is being tested?
- Interviews
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2024to 15 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with MLA Care team
Who may be able to join
- 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
Who cannot join
- Moderate or severe cognitive impairment
- Language barrier
- Other communication disorders
About this study
Official title: 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.
- Conditions
- Myeloid Leukemia
- Being tested
- Interviews
- Keywords
- Advanced Practice Nurse, Acute Myeloid Leukemia,
- Medical subject headings
- Leukemia, Myeloid, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewsOther
Semi-structured interview about perceptions and expectations of APN participation in AML monitoring according to patient and to care team.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described Receives: Other: Interviews | |
| medical staff | Not described Receives: Other: Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 1 month
Secondary outcomes (1)
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.
Measured: Within 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start15 May 2024 (estimated)
- Primary completion15 Aug 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Why it stopped: investigator's unavailability
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer HUET, Principal investigator, CHR Metz Thionville Hopital de Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309018
- Sponsor's protocol ID
- 2021-07Obs-CHRMT
- Acronym
- LAMIPA
- Status last verified
- May 2024
- First submitted
- 25 Mar 2022
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantation of an Advanced Practice Nurse in the Complex Care Pathway of Patients Followed for AML Treated With Oral Targeted Therapy
- ClinicalTrials.gov ID
- NCT05309018
- Acronym / sponsor ID
- LAMIPA / 2021-07Obs-CHRMT
- Conditions
- Myeloid Leukemia
- Keywords
- Advanced Practice Nurse, Acute Myeloid Leukemia,
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: investigator's unavailability
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 15 Aug 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Interviews |
| medical staff | – | Other: Interviews |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with MLA Care team
Key inclusion criteria (7 listed)
- Patient with AML
- Treated with a new targeted oral therapy as monotherapy or in combination:
- Whose follow-up is provided alternately by a hematologist and an IPA.
- Affiliated to a social security scheme
Key exclusion criteria (3 listed)
- Moderate or severe cognitive impairment
- Language barrier
- Other communication disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewsSemi-structured interview about perceptions and expectations of APN participation in AML monitoring according to patient and to care team. | Other | Patients, medical staff |
Primary outcome
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.
1 secondary outcome
Perception of care team
Time frame: Within 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer HUET principal investigator
CHR Metz Thionville Hopital de Mercy
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloid Leukemia, run by Centre Hospitalier Régional Metz-Thionville.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception of patient (time frame: Within 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.