Clinical trial NCT06077110: Precision Care Initiative: Integrating Precision Oncology Into Clinical Programs
Official title: Developing a Novel Precision Medicine Clinic to Drive Integration of Research Into Routine Healthcare: Precision Care Initiative
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Keywords: precision medicine
oncology
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Implementation Outcomes
timeFrame: 3 months post-referral
measure: Implementation Outcomes
timeFrame: 3 months post-referral
measure: Implementation Outcomes
timeFrame: 3 months post-referral
measure: Implementation Outcomes
timeFrame: 3 months post-referral
measure: Implementation Outcomes
timeFrame: 3 months post-referral
measure: Implementation Outcomes
timeFrame: 3 months post-referral
measure: Implementation Outcomes
timeFrame: 3 months post-referral
measure: Implementation Outcomes
timeFrame: 3 months post-referral
measure: Service Outcomes
timeFrame: 3 months post-referral
measure: Service Outcomes
timeFrame: 3 months post-referral
measure: Service Outcomes
timeFrame: 3 months post-referral
measure: Service Outcomes
timeFrame: 3 months post-referral
measure: Clinical Outcomes
timeFrame: 3 months post-referral
Secondary outcomes:
measure: Clinical Outcome: Quality of life improvement (EQ-5D-5L, EuroQol-5 Dimension-5 Level)
timeFrame: 3, 6, 9 months post-referral
measure: Clinical Outcome: Views and attitudes (patient-perceived benefits and drawbacks of process and care model), result return preferences, knowledge, perceived importance of genomic profiling
timeFrame: 3, 6, 9 months post-referral
measure: Clinical Outcome: Psychological outcomes (e.g., anxiety and depression, coping with uncertainty)
timeFrame: 3, 6, 9 months post-referral
measure: Clinical Outcome: Decisional outcomes (e.g., decisional regret regarding personalised treatment, decisional satisfaction)
timeFrame: 3, 6, 9 months post-referral
Other outcomes:
Locations:
Study officials:
affiliation: The University New South Wales
name: Natalie Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
References: