Precision Care Initiative: Integrating Precision Oncology Into Clinical Programs

Официальное название

Developing a Novel Precision Medicine Clinic to Drive Integration of Research Into Routine Healthcare: Precision Care Initiative

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Implementation Outcomes [Срок оценки: 3 months post-referral]
• Implementation Outcomes [Срок оценки: 3 months post-referral]
• Implementation Outcomes [Срок оценки: 3 months post-referral]
• Implementation Outcomes [Срок оценки: 3 months post-referral]
• Implementation Outcomes [Срок оценки: 3 months post-referral]
• Implementation Outcomes [Срок оценки: 3 months post-referral]
• Implementation Outcomes [Срок оценки: 3 months post-referral]
• Implementation Outcomes [Срок оценки: 3 months post-referral]
• Service Outcomes [Срок оценки: 3 months post-referral]
• Service Outcomes [Срок оценки: 3 months post-referral]

Вторичные конечные точки (4)

• Clinical Outcome: Quality of life improvement (EQ-5D-5L, EuroQol-5 Dimension-5 Level) [Срок оценки: 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 [Срок оценки: 3, 6, 9 months post-referral]
• Clinical Outcome: Psychological outcomes (e.g., anxiety and depression, coping with uncertainty) [Срок оценки: 3, 6, 9 months post-referral]
• Clinical Outcome: Decisional outcomes (e.g., decisional regret regarding personalised treatment, decisional satisfaction) [Срок оценки: 3, 6, 9 months post-referral]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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 hy PMID 41093322

Идентификаторы

NCT: NCT06077110 · RG214257 · RARUR000125

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗