Cancer
Conditions
Keywords
precision medicine, oncology
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.
Interventions
OTHERPrecision 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.
Sponsors
The University of New South Wales
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implementation Outcomes | 3 months post-referral | appropriateness (e.g., perceived fit); qualitative measurement collected via interviews/focus groups/questionnaires |
| Service Outcomes | 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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: Decisional outcomes (e.g., decisional regret regarding personalised treatment, decisional satisfaction) | 3, 6, 9 months post-referral | qualitative measures captured via interviews/questionnaires |
| 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 |
Contacts
Primary ContactShuang Liang, PhD
Backup ContactNatalie Taylor, PhD
Outcome results
None listed