The Evaluating Multidisciplinary Bone Marrow Failure Care in Bone Marrow Failure and Related Disorders.
EMBRACE
1 other identifier
observational
100
1 country
1
Brief Summary
This is a prospective hybrid implementation-effectiveness study of a model of care for patients with bone marrow failure syndromes and inherited predisposition to haematological malignancy that includes comprehensive diagnostic genomic evaluation, multidisciplinary case review, provision of clinical care including from clinical haematologists, medical geneticists and genetic counsellors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2021
CompletedFirst Posted
Study publicly available on registry
March 29, 2021
CompletedStudy Start
First participant enrolled
June 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedAugust 23, 2021
August 1, 2021
1.8 years
March 24, 2021
August 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
to assess the effectiveness and implementation of the model of care through a mixture of objective metrics and patient /physician reported outcomes
Effectiveness - patient/physician reported outcomes of satisfaction with model of care as measured by questionnaire Implementation - compliance with of model as measured by audit against pre-specified key performance indicators
12 months
Secondary Outcomes (2)
To assess longitudinal quality of life assessment in patients being treated with the model
12 months
To quantitate healthcare usage of patients within the model
12 months
Study Arms (1)
BMFS patients
Patients with BMFS attending Peter MacCallum Cancer Centre haematology clinic.
Interventions
Eligibility Criteria
Patients with a diagnosis of inherited bone marrow disorder (IBMD) including traditional inherited bone marrow failure syndromes (BMFS) and germline predisposition to haematological malignancy who meet all the inclusion criteria will be eligible for participation in this study.
You may qualify if:
- Patients must meet all the following criteria for study entry:
- Age \> or = 18 years at enrolment
- Able to give informed consent (or responsible family member able to give informed consent)
- Patient is receiving care under the institutional guidelines/stream model of care
You may not qualify if:
- \. Patient not eligible for management under the model of care
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Piers Blombery, MBBS(Hons)
Peter MacCallum Cancer Centre, Australia
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2021
First Posted
March 29, 2021
Study Start
June 9, 2021
Primary Completion
April 1, 2023
Study Completion
April 1, 2024
Last Updated
August 23, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share