Health TrialsbyHealthPanel

Precision Care Initiative: Integrating Precision Oncology Into Clinical Programs

ConditionCancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of New South Wales

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

have been referred to the Precision Care Clinic at POWH

speak English

are aged 18 years or over

are able to provide informed consent

Disqualifiers

aged under 18 years

non-English speaking

are unable to provide informed consent

Trial design

Design model

Single group

Treatments tested in this trial

  • Precision Care Clinic services

    Other intervention

    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.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Precision Care Clinic patientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Implementation Outcomes

appropriateness (e.g., perceived fit); qualitative measurement collected via interviews/focus groups/questionnaires

Time frame
3 months post-referral
2

Implementation Outcomes

acceptability (clinician satisfaction); qualitative measurement collected via interviews/focus groups/questionnaires

Time frame
3 months post-referral
3

Implementation Outcomes

feasibility; qualitative measurement collected via interviews/focus groups/questionnaires

Time frame
3 months post-referral
4

Implementation Outcomes

adoption (e.g., telehealth uptake); qualitative measurement collected via interviews/focus groups/questionnaires

Time frame
3 months post-referral

Secondary outcomes

1

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).

Time frame
3, 6, 9 months post-referral
2

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

Time frame
3, 6, 9 months post-referral
3

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

qualitative measures captured via interviews/questionnaires

Time frame
3, 6, 9 months post-referral
4

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

qualitative measures captured via interviews/questionnaires

Time frame
3, 6, 9 months post-referral

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of New South Wales

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: