Precision Care Initiative: Integrating Precision Oncology Into Clinical Programs

NCT06077110 | Not Yet Recruiting

• 2 other identifiers: RG214257RARUR000125
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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. 1.Co-design a Precision Care Clinic, its implementation platform and suite of outcome measures (Phase 1)
2. 2.Test the implementation-, service-, clinical, and cost-effectiveness of a Precision Care Clinic (Phase 2)
3. 3.Develop and pilot test a Precision Care scale-up model and toolkit (Phase 3)

Conditions

Cancer

Keywords

precision medicine; oncology

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (4)

• Clinical Outcome: Quality of life improvement (EQ-5D-5L, EuroQol-5 Dimension-5 Level)

  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

  3, 6, 9 months post-referral

• Clinical Outcome: Psychological outcomes (e.g., anxiety and depression, coping with uncertainty)

  3, 6, 9 months post-referral

• Clinical Outcome: Decisional outcomes (e.g., decisional regret regarding personalised treatment, decisional satisfaction)

  3, 6, 9 months post-referral

Study Arms (1)

Precision Care Clinic patients

EXPERIMENTAL

Other: Precision Care Clinic services

Interventions

Precision Care Clinic services OTHER

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.

Precision Care Clinic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have been referred to the Precision Care Clinic at POWH
• speak English
• are aged 18 years or over
• are able to provide informed consent

You may not qualify if:

• aged under 18 years
• non-English speaking
• are unable to provide informed consent

Sponsors & Collaborators

• The University of New South Wales: lead

Related Publications (1)

• Liang S, McKay S, Lin F, Zaheed M, Morrow A, Douglas B, Chan J, Monaghan H, Chan P, Kennedy E, Tyedmers E, Walker S, Leaney K, Napier CE, Middleton S, Butow P, Williams R, Parkinson B, Ballinger ML, Tucker K, Goldstein D, Thomas D, Taylor N. Integration of precision medicine into routine cancer care-protocol for the Precision Care Initiative: a research programme of effectiveness-implementation hybrid trials. BMJ Open. 2025 Oct 15;15(10):e090270. doi: 10.1136/bmjopen-2024-090270.

  PMID: 41093322 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Natalie Taylor, PhD

  The University New South Wales

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuang Liang, PhD

CONTACT

+61 2 9348 1126; shuang.liang4@unsw.edu.au

Natalie Taylor, PhD

CONTACT

+61 2 9348 1126; natalie.taylor@unsw.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 11, 2023
• Study Start: May 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 28, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share