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

Cancer Clinical Trial

— P-OMICs-flow  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06077110
• Other study ID #: RG214257
• Secondary ID: RARUR000125
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: March 2027

Study information

• Verified date: October 2023
• Source: The University of New South Wales
• Contact: Shuang Liang, PhD
• Phone: +61 2 9348 1126
• Email: shuang.liang4[@]unsw.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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: 1. Co-design a clinic, implementation platform and suite of outcome measures to optimise P-OMICs-flow (Phase 1) 2. Test the implementation, service-, clinical, and cost-effectiveness of P-OMICs-flow (Phase 2) 3. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: March 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• P-OMICs-flow services
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of New South Wales

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implementation Outcomes	appropriateness (e.g., perceived fit); qualitative measurement collected via interviews/focus groups/questionnaires	3 months post-referral
Primary	Implementation Outcomes	acceptability (clinician satisfaction); qualitative measurement collected via interviews/focus groups/questionnaires	3 months post-referral
Primary	Implementation Outcomes	feasibility; qualitative measurement collected via interviews/focus groups/questionnaires	3 months post-referral
Primary	Implementation Outcomes	adoption (e.g., telehealth uptake); qualitative measurement collected via interviews/focus groups/questionnaires	3 months post-referral
Primary	Implementation Outcomes	fidelity (care model adopted as intended); qualitative measurement collected via interviews/focus groups/questionnaires	3 months post-referral
Primary	Implementation Outcomes	cost (e.g., immediate versus ongoing implementation resource); qualitative measurement collected via interviews/focus groups/questionnaires	3 months post-referral
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Clinical Outcome: Psychological outcomes (e.g., anxiety and depression, coping with uncertainty)	qualitative measures captured via interviews/questionnaires	3, 6, 9 months post-referral
Secondary	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