Cancer Clinical Trial - P-OMICs-flow: Integrating Precision Oncology Into

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Cancer

Clinical Trial Details

NCT number	NCT06077110
Study type	Interventional
Source	The University of New South Wales
Contact	Shuang Liang, PhD
Phone	+61 2 9348 1126
Email	shuang.liang4@unsw.edu.au
Status	Not yet recruiting
Phase	N/A
Start date	October 2023
Completion date	March 2027

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

P-OMICs-flow: Integrating Precision Oncology Into Clinical Programs — P-OMICs-flow

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms