Precision Care Initiative: Integrating Precision Oncology Into Clinical Programs
- Conditions
- Cancer
- Interventions
- Other: P-OMICs-flow services
- Registration Number
- NCT06077110
- Lead Sponsor
- The University of New South Wales
- Brief 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 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
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- have been referred to the Precision Care Clinic at POWH
- speak English
- are aged 18 years or over
- are able to provide informed consent
- aged under 18 years
- non-English speaking
- are unable to provide informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description P-OMICs-flow patients P-OMICs-flow services -
- Primary Outcome Measures
Name Time Method Implementation Outcomes 3 months post-referral sustainability \[industry engagement, grant support; clinical trial \& access options, research links (e.g., sub-studies) generated\]; qualitative measurement collected via interviews/focus groups/questionnaires
Service Outcomes 3 months post-referral 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.
Clinical Outcomes 3 months post-referral 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.
- Secondary Outcome Measures
Name Time Method Clinical Outcome: Quality of life improvement (EQ-5D-5L, EuroQol-5 Dimension-5 Level) 3, 6, 9 months post-referral 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).
Clinical Outcome: Views and attitudes (patient-perceived benefits and drawbacks of process and care model), result return preferences, knowledge, perceived importance of genomic profiling 3, 6, 9 months post-referral qualitative measures captured via interviews/questionnaires
Clinical Outcome: Psychological outcomes (e.g., anxiety and depression, coping with uncertainty) 3, 6, 9 months post-referral qualitative measures captured via interviews/questionnaires
Clinical Outcome: Decisional outcomes (e.g., decisional regret regarding personalised treatment, decisional satisfaction) 3, 6, 9 months post-referral qualitative measures captured via interviews/questionnaires