P-OMICs-flow: Integrating Precision Oncology Into Clinical Programs

Study Overview
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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 P-OMICs-flow model of care 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: Co-design a clinic, implementation platform and suite of outcome measures to optimise P-OMICs-flow (Phase 1) Test the implementation, service-, clinical, and cost-effectiveness of P-OMICs-flow (Phase 2) Develop and pilot test a P-OMICs-flow 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 the P-OMICs-flow 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 P-OMICs-flow 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.

Official Title
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Developing a Novel Precision Medicine Clinic to Drive Integration of Research Into Routine Healthcare: P-OMICs-flow

Conditions
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Cancer

Intervention / Treatment
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* Other: P-OMICs-flow services


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: have been referred to the P-OMICs-flow 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: P-OMICs-flow patients<br> | Other: P-OMICs-flow services<br>* The Service Intervention is the P-OMICs-flow 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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precision medicine, oncology