CancerNCT06077110
Precision Care Initiative: Integrating Precision Oncology Into Clinical Programs
A study testing Precision Care Clinic services in people with Cancer, run by The University of New South Wales.
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 Precision Care Clinic within the Prince of Wales Hospital, but also prime it for use within other health care sites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Precision Care Clinic services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have been referred to the Precision Care Clinic at POWH
- speak English
- are aged 18 years or over
- are able to provide informed consent
Who cannot join
- aged under 18 years
- non-English speaking
- are unable to provide informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Developing a Novel Precision Medicine Clinic to Drive Integration of Research Into Routine Healthcare: Precision Care Initiative
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:
- Co-design a Precision Care Clinic, its implementation platform and suite of outcome measures (Phase 1)
- Test the implementation-, service-, clinical, and cost-effectiveness of a Precision Care Clinic (Phase 2)
- Develop and pilot test a Precision Care scale-up model and toolkit (Phase 3)
Read more
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.
- Conditions
- Cancer
- Being tested
- Precision Care Clinic services
- Keywords
- precision medicine, oncology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precision Care Clinic servicesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Precision Care Clinic patients | Experimental | Not described Receives: Other: Precision Care Clinic services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation Outcomes
appropriateness (e.g., perceived fit); qualitative measurement collected via interviews/focus groups/questionnaires
Measured: 3 months post-referral
Implementation Outcomes
acceptability (clinician satisfaction); qualitative measurement collected via interviews/focus groups/questionnaires
Measured: 3 months post-referral
Implementation Outcomes
feasibility; qualitative measurement collected via interviews/focus groups/questionnaires
Measured: 3 months post-referral
Implementation Outcomes
adoption (e.g., telehealth uptake); qualitative measurement collected via interviews/focus groups/questionnaires
Measured: 3 months post-referral
Implementation Outcomes
fidelity (care model adopted as intended); qualitative measurement collected via interviews/focus groups/questionnaires
Measured: 3 months post-referral
Implementation Outcomes
cost (e.g., immediate versus ongoing implementation resource); qualitative measurement collected via interviews/focus groups/questionnaires
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months post-referral
Secondary outcomes (4)
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).
Measured: 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
Measured: 3, 6, 9 months post-referral
Clinical Outcome: Psychological outcomes (e.g., anxiety and depression, coping with uncertainty)
qualitative measures captured via interviews/questionnaires
Measured: 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
Measured: 3, 6, 9 months post-referral
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study startMay 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalie Taylor, The University of New South Wales
- Investigators
- Natalie Taylor, PhD, Principal investigator, The University New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077110
- Sponsor's protocol ID
- RG214257
- Other IDs
- RARUR000125
- Status last verified
- Jun 2024
- First submitted
- 21 Sep 2023
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41093322
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Novel Precision Medicine Clinic to Drive Integration of Research Into Routine Healthcare: Precision Care Initiative
- ClinicalTrials.gov ID
- NCT06077110
- Acronym / sponsor ID
- RG214257
- Conditions
- Cancer
- Keywords
- precision medicine, oncology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Co-design a Precision Care Clinic, its implementation platform and suite of outcome measures (Phase 1)
- Test the implementation-, service-, clinical, and cost-effectiveness of a Precision Care Clinic (Phase 2)
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Precision Care Clinic patients | Experimental | Other: Precision Care Clinic services |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- have been referred to the Precision Care Clinic at POWH
- speak English
- are aged 18 years or over
- are able to provide informed consent
Key exclusion criteria (3 listed)
- aged under 18 years
- non-English speaking
- are unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Precision Care Clinic servicesThe 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. | Other | Precision Care Clinic patients |
Primary outcome
Implementation Outcomes
Time frame: 3 months post-referral
appropriateness (e.g., perceived fit); qualitative measurement collected via interviews/focus groups/questionnaires
Implementation Outcomes
Time frame: 3 months post-referral
acceptability (clinician satisfaction); qualitative measurement collected via interviews/focus groups/questionnaires
Implementation Outcomes
Time frame: 3 months post-referral
feasibility; qualitative measurement collected via interviews/focus groups/questionnaires
Implementation Outcomes
Time frame: 3 months post-referral
adoption (e.g., telehealth uptake); qualitative measurement collected via interviews/focus groups/questionnaires
Implementation Outcomes
Time frame: 3 months post-referral
fidelity (care model adopted as intended); qualitative measurement collected via interviews/focus groups/questionnaires
Implementation Outcomes
Time frame: 3 months post-referral
cost (e.g., immediate versus ongoing implementation resource); qualitative measurement collected via interviews/focus groups/questionnaires
Implementation Outcomes
Time frame: 3 months post-referral
penetration (e.g., research enrolment numbers including culturally and linguistically diverse, remote/regional); qualitative measurement collected via interviews/focus groups/questionnaires
Implementation Outcomes
Time frame: 3 months post-referral
sustainability [industry engagement, grant support; clinical trial \& access options, research links (e.g., sub-studies) generated]; qualitative measurement collected via interviews/focus groups/questionnaires
Service Outcomes
Time frame: 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.
Service Outcomes
Time frame: 3 months post-referral
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.
Service Outcomes
Time frame: 3 months post-referral
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.
Service Outcomes
Time frame: 3 months post-referral
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.
Clinical Outcomes
Time frame: 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.
4 secondary outcomes
Clinical Outcome: Quality of life improvement (EQ-5D-5L, EuroQol-5 Dimension-5 Level)
Time frame: 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
Time frame: 3, 6, 9 months post-referral
Clinical Outcome: Psychological outcomes (e.g., anxiety and depression, coping with uncertainty)
Time frame: 3, 6, 9 months post-referral
Clinical Outcome: Decisional outcomes (e.g., decisional regret regarding personalised treatment, decisional satisfaction)
Time frame: 3, 6, 9 months post-referral
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Derived from this study: PubMed 41093322Liang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Natalie Taylor, PhD principal investigator
The University New South Wales
Questions about this trial
What is this clinical trial studying?
A study testing Precision Care Clinic services in people with Cancer, run by The University of New South Wales.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuang Liang, PhD (+61 2 9348 1126, shuang.liang4@unsw.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation Outcomes (time frame: 3 months post-referral). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06077110, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.