The use of a risk assessment and decision support tool (CRISP) compared with usual care in general practice to increase risk-stratified colorectal cancer screening: study protocol for a randomised controlled trial
Jennifer G. Walker,
Finlay Macrae,
Ingrid Winship,
Jasmeen Oberoi,
Sibel Saya,
Shakira Milton,
Adrian Bickerstaffe,
James G. Dowty,
Richard De Abreu Lourenço,
Malcolm Clark,
Louise Galloway,
George Fishman,
Fiona M. Walter,
Louisa Flander,
Patty Chondros,
Driss Ait Ouakrim,
Marie Pirotta,
Lyndal Trevena,
Mark A. Jenkins,
Jon D. Emery
Affiliations
Jennifer G. Walker
Centre for Cancer Research, Department of General Practice, Victorian Comprehensive Cancer Centre, The University of Melbourne
Finlay Macrae
Department of Medicine, The University of Melbourne
Ingrid Winship
Department of Medicine, The University of Melbourne
Jasmeen Oberoi
Centre for Cancer Research, Department of General Practice, Victorian Comprehensive Cancer Centre, The University of Melbourne
Sibel Saya
Centre for Cancer Research, Department of General Practice, Victorian Comprehensive Cancer Centre, The University of Melbourne
Shakira Milton
Centre for Cancer Research, Department of General Practice, Victorian Comprehensive Cancer Centre, The University of Melbourne
Adrian Bickerstaffe
Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne
James G. Dowty
Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne
Richard De Abreu Lourenço
Centre for Health Economics Research and Evaluation, University of Technology Sydney
Malcolm Clark
Centre for Cancer Research, Department of General Practice, Victorian Comprehensive Cancer Centre, The University of Melbourne
Louise Galloway
Department of Health and Human Services, Victorian Government
George Fishman
Joint Consumer Advisory Group, Primary Care Collaborative Cancer Clinical Trials Group
Fiona M. Walter
Centre for Cancer Research, Department of General Practice, Victorian Comprehensive Cancer Centre, The University of Melbourne
Louisa Flander
Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne
Patty Chondros
Department of General Practice, The University of Melbourne
Driss Ait Ouakrim
Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne
Marie Pirotta
Centre for Cancer Research, Department of General Practice, Victorian Comprehensive Cancer Centre, The University of Melbourne
Lyndal Trevena
School of Public Health, The University of Sydney
Mark A. Jenkins
Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne
Jon D. Emery
Centre for Cancer Research, Department of General Practice, Victorian Comprehensive Cancer Centre, The University of Melbourne
Abstract Background Australia and New Zealand have the highest incidence rates of colorectal cancer worldwide. In Australia there is significant unwarranted variation in colorectal cancer screening due to low uptake of the immunochemical faecal occult blood test, poor identification of individuals at increased risk of colorectal cancer, and over-referral of individuals at average risk for colonoscopy. Our pre-trial research has developed a novel Colorectal cancer RISk Prediction (CRISP) tool, which could be used to implement precision screening in primary care. This paper describes the protocol for a phase II multi-site individually randomised controlled trial of the CRISP tool in primary care. Methods This trial aims to test whether a standardised consultation using the CRISP tool in general practice (the CRISP intervention) increases risk-appropriate colorectal cancer screening compared to control participants who receive standardised information on cancer prevention. Patients between 50 and 74 years old, attending an appointment with their general practitioner for any reason, will be invited into the trial. A total of 732 participants will be randomised to intervention or control arms using a computer-generated allocation sequence stratified by general practice. The primary outcome (risk-appropriate screening at 12 months) will be measured using baseline data for colorectal cancer risk and objective health service data to measure screening behaviour. Secondary outcomes will include participant cancer risk perception, anxiety, cancer worry, screening intentions and health service utilisation measured at 1, 6 and 12 months post randomisation. Discussion This trial tests a systematic approach to implementing risk-stratified colorectal cancer screening in primary care, based on an individual’s absolute risk, using a state-of-the-art risk assessment tool. Trial results will be reported in 2020. Trial registration Australian and New Zealand Clinical Trial Registry, ACTRN12616001573448p. Registered on 14 November 2016.
