Precision Care Initiative: Integrating Precision Oncology Into Clinical Programs

The University of New South Wales

Status: Not yet enrolling

Conditions: Cancer

Treatments: Other: Precision Care Clinic services

Study type: Interventional

Funder types: Other

Identifiers

NCT06077110

RARUR000125 (Other Grant/Funding Number)

RG214257

Details and patient eligibility

About

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 Precision Care Clinic 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 Precision Care Clinic, its implementation platform and suite of outcome measures (Phase 1)
2. Test the implementation-, service-, clinical, and cost-effectiveness of a Precision Care Clinic (Phase 2)
3. Develop and pilot test a Precision Care 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 this novel 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 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• have been referred to the Precision Care 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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Precision Care Clinic patients

Experimental group

Treatment:

Other: Precision Care Clinic services