[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522016":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":51,"studyPopulation":51,"armGroups":58,"interventions":64,"overallOfficials":69,"centralContacts":74,"locations":51,"responsibleParty":82,"collaborators":51,"id":85,"slug":51,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":51,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":51,"enrollmentInfo":93,"targetDuration":51,"studyType":96,"phases":97,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":104,"whyStopped":51,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":51},{"fullName":5,"class":6},"The University of New South Wales","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":39,"otherOutcomes":51},[9,13,15,17,19,21,23,25,27,30,32,34,36],{"measure":10,"description":11,"timeFrame":12},"Implementation Outcomes","appropriateness (e.g., perceived fit); qualitative measurement collected via interviews\u002Ffocus groups\u002Fquestionnaires","3 months post-referral",{"measure":10,"description":14,"timeFrame":12},"acceptability (clinician satisfaction); qualitative measurement collected via interviews\u002Ffocus groups\u002Fquestionnaires",{"measure":10,"description":16,"timeFrame":12},"feasibility; qualitative measurement collected via interviews\u002Ffocus groups\u002Fquestionnaires",{"measure":10,"description":18,"timeFrame":12},"adoption (e.g., telehealth uptake); qualitative measurement collected via interviews\u002Ffocus groups\u002Fquestionnaires",{"measure":10,"description":20,"timeFrame":12},"fidelity (care model adopted as intended); qualitative measurement collected via interviews\u002Ffocus groups\u002Fquestionnaires",{"measure":10,"description":22,"timeFrame":12},"cost (e.g., immediate versus ongoing implementation resource); qualitative measurement collected via interviews\u002Ffocus groups\u002Fquestionnaires",{"measure":10,"description":24,"timeFrame":12},"penetration (e.g., research enrolment numbers including culturally and linguistically diverse, remote\u002Fregional); qualitative measurement collected via interviews\u002Ffocus groups\u002Fquestionnaires",{"measure":10,"description":26,"timeFrame":12},"sustainability \\[industry engagement, grant support; clinical trial \\& access options, research links (e.g., sub-studies) generated\\]; qualitative measurement collected via interviews\u002Ffocus groups\u002Fquestionnaires",{"measure":28,"description":29,"timeFrame":12},"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.",{"measure":28,"description":31,"timeFrame":12},"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.",{"measure":28,"description":33,"timeFrame":12},"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.",{"measure":28,"description":35,"timeFrame":12},"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.",{"measure":37,"description":38,"timeFrame":12},"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.",[40,44,47,49],{"measure":41,"description":42,"timeFrame":43},"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",{"measure":45,"description":46,"timeFrame":43},"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\u002Fquestionnaires",{"measure":48,"description":46,"timeFrame":43},"Clinical Outcome: Psychological outcomes (e.g., anxiety and depression, coping with uncertainty)",{"measure":50,"description":46,"timeFrame":43},"Clinical Outcome: Decisional outcomes (e.g., decisional regret regarding personalised treatment, decisional satisfaction)",null,{"allocation":53,"interventionModel":54,"interventionModelDescription":51,"primaryPurpose":55,"observationalModel":51,"timePerspective":51,"maskingInfo":56},"NA","SINGLE_GROUP","HEALTH_SERVICES_RESEARCH",{"masking":57,"maskingDescription":51,"whoMasked":51},"NONE",[59],{"label":60,"type":61,"description":51,"interventionNames":62},"Precision Care Clinic patients","EXPERIMENTAL",[63],"Other: Precision Care Clinic services",[65],{"type":6,"name":66,"description":67,"armGroupLabels":68,"otherNames":51},"Precision Care Clinic services","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.",[60],[70],{"name":71,"affiliation":72,"role":73},"Natalie Taylor, PhD","The University New South Wales","PRINCIPAL_INVESTIGATOR",[75,80],{"name":76,"role":77,"phone":78,"phoneExt":51,"email":79},"Shuang Liang, PhD","CONTACT","+61 2 9348 1126","shuang.liang4@unsw.edu.au",{"name":71,"role":77,"phone":78,"phoneExt":51,"email":81},"natalie.taylor@unsw.edu.au",{"type":73,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":51,"oldOrganization":51},"Natalie Taylor","Associate Professor","100522016",false,"NCT06077110","Precision Care Initiative: Integrating Precision Oncology Into Clinical Programs","Developing a Novel Precision Medicine Clinic to Drive Integration of Research Into Routine Healthcare: Precision Care Initiative","Inclusion Criteria:\n\n* have been referred to the Precision Care Clinic at POWH\n* speak English\n* are aged 18 years or over\n* are able to provide informed consent\n\nExclusion Criteria:\n\n* aged under 18 years\n* non-English speaking\n* are unable to provide informed consent","ALL","18 Years",{"count":94,"type":95},300,"ESTIMATED","INTERVENTIONAL",[53],"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:\n\n1. Co-design a Precision Care Clinic, its implementation platform and suite of outcome measures (Phase 1)\n2. Test the implementation-, service-, clinical, and cost-effectiveness of a Precision Care Clinic (Phase 2)\n3. Develop and pilot test a Precision Care scale-up model and toolkit (Phase 3)\n\nA 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)\n\nIt 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.",[100],"Cancer",[102,103],"precision medicine","oncology","NOT_YET_RECRUITING","2025-03-24",{"date":107,"type":108},"2025-03-28","ACTUAL",{"date":110,"type":95},"2025-05",{"date":112,"type":95},"2027-03",{"name":5,"class":6}]