Precision Care Initiative: Integrating Precision Oncology Into Clinical Programs

NCT ID: NCT06077110

Last Updated: 2025-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-31

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Precision Care Clinic patients

Group Type EXPERIMENTAL

Precision Care Clinic services

Intervention Type OTHER

The Service Intervention is the Precision Care 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.

Interventions

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Precision Care Clinic services

The Service Intervention is the Precision Care 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of New South Wales

OTHER

Sponsor Role lead

Responsible Party

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Natalie Taylor

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Natalie Taylor, PhD

Role: PRINCIPAL_INVESTIGATOR

The University New South Wales

Central Contacts

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Shuang Liang, PhD

Role: CONTACT

+61 2 9348 1126

Natalie Taylor, PhD

Role: CONTACT

+61 2 9348 1126

References

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Liang S, McKay S, Lin F, Zaheed M, Morrow A, Douglas B, Chan J, Monaghan H, Chan P, Kennedy E, Tyedmers E, Walker S, Leaney K, Napier CE, Middleton S, Butow P, Williams R, Parkinson B, Ballinger ML, Tucker K, Goldstein D, Thomas D, Taylor N. Integration of precision medicine into routine cancer care-protocol for the Precision Care Initiative: a research programme of effectiveness-implementation hybrid trials. BMJ Open. 2025 Oct 15;15(10):e090270. doi: 10.1136/bmjopen-2024-090270.

Reference Type DERIVED
PMID: 41093322 (View on PubMed)

Other Identifiers

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RARUR000125

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

RG214257

Identifier Type: -

Identifier Source: org_study_id

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