To hear about similar clinical trials, please enter your email below
Trial Title:
P-OMICs-flow: Integrating Precision Oncology Into Clinical Programs
NCT ID:
NCT06077110
Condition:
Cancer
Conditions: Keywords:
precision medicine
oncology
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
P-OMICs-flow services
Description:
The Service Intervention is the P-OMICs-flow clinic being delivered at The Prince of
Wales Hospital. This clinic provides a streamlined, multidisciplinary model to seamlessly
integrate research-led precision medicine into the routine oncology setting.
Arm group label:
P-OMICs-flow patients
Summary:
The purpose of this study is to drive integration of precision medicine into routine
oncology healthcare. It is hoped that this research will not only optimise the newly
established P-OMICs-flow model of care within The Prince of Wales Hospital, but also
prime it for use within other health care sites. The multidisciplinary team will work to
achieve the following three objectives:
1. Co-design a clinic, implementation platform and suite of outcome measures to
optimise P-OMICs-flow (Phase 1)
2. Test the implementation, service-, clinical, and cost-effectiveness of P-OMICs-flow
(Phase 2)
3. Develop and pilot test a P-OMICs-flow scale-up model and toolkit (Phase 3)
A mixed-methods approach will be used to develop and evaluate an implementation platform
to support the integration of precision medicine into the routine oncology setting at a
single hospital site. In the first study phase, interviews and focus-groups will be used
to develop the implementation platform, which involves a co-designed model of care
supported by a Learning Health System. A Type II Hybrid effectiveness-implementation
trial design will then be used to test the implementation, clinical, and
cost-effectiveness of the P-OMICs-flow model of care (phase 2). A combination of patient
surveys and interviews will be used to measure patient-reported outcome measures (PROMs)
and patient-reported experience measures (PREMs); stakeholder and patient interviews,
surveys and focus-groups will be used to measure implementation outcomes; and cost data
will be collected to inform an economic evaluation. These data will be collected at
various stages of implementation to evaluate the effectiveness of the P-OMICs-flow model
of care over time. In the final study phase (phase 3), a scale-up model will be developed
to support implementation of the new model of care across a wider range of clinical
contexts. (Phase 3 will be detailed in a separate ethics amendment)
It is hoped that this research will not only optimise the newly established model of care
within The Prince of Wales Hospital, but also prime it for use within other health care
sites.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- have been referred to the P-OMICs-flow clinic at POWH
- speak English
- are aged 18 years or over
- are able to provide informed consent
Exclusion Criteria:
- aged under 18 years
- non-English speaking
- are unable to provide informed consent
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 2023
Completion date:
March 2027
Lead sponsor:
Agency:
The University of New South Wales
Agency class:
Other
Source:
The University of New South Wales
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06077110
