Introduction Effective implementation of a research Program requires an actionable plan to guide execution. To assess the actionability and success of that plan, both scientific and implementation elements must be taken into account. The aim of this study is to assess the ‘Zero Childhood Cancer Personalised Medicine Program’ (the Zero Program), an Australian first-ever and most comprehensive personalised medicine programme for children with high-risk or relapsed cancer, in terms of its structure, process and implementational effect.
Methods and analysis We will assess Program delivery mechanisms. The development of the implementation and evaluation strategy will concentrate on the work of the Zero Program as a complex whole. This includes the structure of collaborative links across stakeholder groups involved in Program development and delivery, changes to collaborative relationships over time and the impact of group working on Program outcomes. We are applying a mixed-methods design including: a rapid ethnography (observations of stakeholder interactions and informal conversations), Program professionals’ completion of a rapid health implementation proforma and a social network analysis. Formative evaluations of the implementation science effects, applying feedback techniques, for example, Formative Evaluation Feedback Loops and the Zero Program professionals’ feedback, will determine where Program tailoring may be needed. A repeat of the social network analysis downstream will examine network changes over time, followed by an expert panel using the expert recommendations for implementing change to assess the integration of implementation strategies into the Program structure. A summative evaluation of the Program will bring the research elements together, leading to comprehensive data triangulation and determining the sustainability and implementational effects of Program delivery.
Ethics and dissemination Ethical approval for this study has been granted by Hunter New England Research Ethics Committee, New South Wales, Australia (approval ref: 2019/ETH12025). Knowledge translation will be achieved through publications, reports and conference presentations to healthcare professionals, patients, families and researchers.
Trial Registration NCT03336931; Pre-results.
- childhood cancer, genomics
- mixed methods research
- implementation science
- precision medicine
- rapid-cycle evaluation
- rapid ethnography
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Contributors FR is the guarantor for this study. FR, JB, JS, TAO, VJT, JCL, HG and EVAM conceived, designed and conducted the study over multiple iterations. JS, FR and JB further fine-tuned the study. The manuscript development was coordinated by JS with assistance from FR and JB. All authors edited the manuscript for important intellectual content and approved the final version. The following members of the study group contributed to the developing research question, planning the protocol of work, gaining funding and/or delivery of this research project: research question development; FR, JB, JS, JCL, HG, EVAM, TAO and VJT. Protocol: all authors. Funding: TAO and VJT. Delivery of research project: all authors.
Funding The study was funded by via Paediatrio Ltd as part of the Paediatric Precision Medicine Program 5 for this project. Paediatrio Ltd is a non-for-profit cooperative joint venture between Sydney Children’s Hospitals Network, Children’s Medical Research Institute and Children’s Cancer Institute established with the support of the NSW Government to coordinate and integrate paediatric research. Paediatrio is also affiliated with The University of Sydney and UNSW Sydney. Significant in-kind contributions were provided by the Zero Childhood Cancer Program. The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of Paediatrio Ltd. The funder had no involvement in: the collection, analysis and interpretation of data; in the writing of the report and in the decision to submit the article for publication.
Competing interests All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf. JB reported grants from NSW Health during the conduct of the study. The other authors declared that there are no relevant conflicts of interests.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
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