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| ID | Type | Description | Link |
|---|---|---|---|
| RARUR000125 | Other Grant/Funding Number | National Health and Medical Research Council |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Precision Care Clinic patients | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Precision Care Clinic services | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Implementation Outcomes | appropriateness (e.g., perceived fit); qualitative measurement collected via interviews/focus groups/questionnaires | 3 months post-referral |
| Implementation Outcomes | acceptability (clinician satisfaction); qualitative measurement collected via interviews/focus groups/questionnaires | 3 months post-referral |
| Implementation Outcomes | feasibility; qualitative measurement collected via interviews/focus groups/questionnaires | 3 months post-referral |
| Implementation Outcomes | adoption (e.g., telehealth uptake); qualitative measurement collected via interviews/focus groups/questionnaires | 3 months post-referral |
| Implementation Outcomes | fidelity (care model adopted as intended); qualitative measurement collected via interviews/focus groups/questionnaires | 3 months post-referral |
| Implementation Outcomes | cost (e.g., immediate versus ongoing implementation resource); qualitative measurement collected via interviews/focus groups/questionnaires | 3 months post-referral |
| Implementation Outcomes | penetration (e.g., research enrolment numbers including culturally and linguistically diverse, remote/regional); qualitative measurement collected via interviews/focus groups/questionnaires |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcome: Quality of life improvement (EQ-5D-5L, EuroQol-5 Dimension-5 Level) | Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). There are 3,125 possible health states defined by combining one level from each dimension, ranging from 11111 (full health) to 55555 (worst health). | 3, 6, 9 months post-referral |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuang Liang, PhD | Contact | +61 2 9348 1126 | shuang.liang4@unsw.edu.au | |
| Natalie Taylor, PhD | Contact | +61 2 9348 1126 | natalie.taylor@unsw.edu.au |
| Name | Affiliation | Role |
|---|---|---|
| Natalie Taylor, PhD | The University New South Wales | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41093322 | Derived | 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. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| 3 months post-referral |
| Implementation Outcomes | sustainability [industry engagement, grant support; clinical trial & access options, research links (e.g., sub-studies) generated]; qualitative measurement collected via interviews/focus groups/questionnaires | 3 months post-referral |
| Service Outcomes | Upstream indicators of clinical effectiveness: intervals between time from referral to treatment; captured via audit data; measured in days; a smaller value indicates a preferred outcome. | 3 months post-referral |
| Service Outcomes | Upstream indicators of clinical effectiveness that include: uptake of precision oncology treatment recommendations; captured via audit data; measured in percentages; a higher value indicates a preferred outcome. | 3 months post-referral |
| Service Outcomes | Upstream indicators of clinical effectiveness that include: time from identification of germline research result to familial cancer clinic referral; captured via audit data, measured in days; a smaller value indicates a preferred outcome. | 3 months post-referral |
| Service Outcomes | Upstream indicators of clinical effectiveness that include: time from identification of germline research result to clinical confirmation; captured via audit data, measured in days; a smaller value indicates a preferred outcome. | 3 months post-referral |
| Clinical Outcomes | Patient reported experience of coordinated care; collected via questionnaires adapted for the precision medicine context; measured as ratings; a higher rating indicates a preferred outcome. | 3 months post-referral |
| Clinical Outcome: Views and attitudes (patient-perceived benefits and drawbacks of process and care model), result return preferences, knowledge, perceived importance of genomic profiling | qualitative measures captured via interviews/questionnaires | 3, 6, 9 months post-referral |
| Clinical Outcome: Psychological outcomes (e.g., anxiety and depression, coping with uncertainty) | qualitative measures captured via interviews/questionnaires | 3, 6, 9 months post-referral |
| Clinical Outcome: Decisional outcomes (e.g., decisional regret regarding personalised treatment, decisional satisfaction) | qualitative measures captured via interviews/questionnaires | 3, 6, 9 months post-referral |