NCT Number: NCT06077110
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.
Trial opening soon.
Get NotifiedHealthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 3 months post-referral
appropriateness (e.g., perceived fit); qualitative measurement collected via interviews/focus groups/questionnaires
Time frame: 3 months post-referral
acceptability (clinician satisfaction); qualitative measurement collected via interviews/focus groups/questionnaires
Time frame: 3 months post-referral
feasibility; qualitative measurement collected via interviews/focus groups/questionnaires
Time frame: 3 months post-referral
adoption (e.g., telehealth uptake); qualitative measurement collected via interviews/focus groups/questionnaires
Time frame: 3 months post-referral
fidelity (care model adopted as intended); qualitative measurement collected via interviews/focus groups/questionnaires
Time frame: 3 months post-referral
cost (e.g., immediate versus ongoing implementation resource); qualitative measurement collected via interviews/focus groups/questionnaires
Time frame: 3 months post-referral
penetration (e.g., research enrolment numbers including culturally and linguistically diverse, remote/regional); qualitative measurement collected via interviews/focus groups/questionnaires
Time frame: 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
Time frame: 3 months post-referral
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.
Time frame: 3 months post-referral
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.
Time frame: 3 months post-referral
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 3, 6, 9 months post-referral
qualitative measures captured via interviews/questionnaires
Time frame: 3, 6, 9 months post-referral
qualitative measures captured via interviews/questionnaires
Time frame: 3, 6, 9 months post-referral
qualitative measures captured via interviews/questionnaires
Contact information is provided by the study sponsor or research team.
Natalie Taylor, PhD
CONTACT
Shuang Liang, PhD
CONTACT
The University of New South Wales
Other
Developing a Novel Precision Medicine Clinic to Drive Integration of Research Into Routine Healthcare: Precision Care Initiative
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