Penelope Schofield1,2,3,4, Karla Gough5,6, Amelia Hyatt5, Alan White5, Mark Frydenberg7,8, Suzanne Chambers9,10,11,12, Louisa G Gordon13,14,15, Robert Gardiner16,17, Declan G Murphy18,19, Lawrence Cavedon20, Natalie Richards5, Barbara Murphy21,22, Stephen Quinn23, Ilona Juraskova24. 1. Department of Psychology, Swinburne University of Technology, Melbourne, Victoria, Australia. pschofield@swin.edu.au. 2. Behavioural Science Unit, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia. pschofield@swin.edu.au. 3. Sir Peter MacCallum Department of Oncology, The University of Melbourne, Parkville, Victoria, Australia. pschofield@swin.edu.au. 4. Swinburne University of Technology, John Street, Hawthorn, Australia. pschofield@swin.edu.au. 5. Behavioural Science Unit, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia. 6. Department of Nursing, The University of Melbourne, Parkville, Victoria, Australia. 7. Department of Urology, Cabrini Institute, Cabrini Health, Malvern, Australia. 8. Department of Surgery, Monash University, Melbourne, Victoria, Australia. 9. Faculty of Health, University of Technology Sydney, Sydney, Australia. 10. Health and Wellness Institute, Edith Cowan University, Perth, Australia. 11. Institute for Resilient Regions, University of Southern Queensland, Springfield, Australia. 12. Menzies Health Institute Queensland, Griffith University, Southport, Australia. 13. Population Health Department, Health Economics, QIMR Berghofer Medical Research Institute, Brisbane, Queensland, Australia. 14. School of Nursing, Queensland University of Technology (QUT), Brisbane, Queensland, Australia. 15. School of Public Health, University of Queensland, Brisbane, Queensland, Australia. 16. School of Medicine, University of Queensland, Brisbane, Queensland, Australia. 17. Department of Urology, Royal Brisbane & Women's Hospital, Herston, Queensland, Australia. 18. Sir Peter MacCallum Department of Oncology, The University of Melbourne, Parkville, Victoria, Australia. 19. Division of Cancer Surgery, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia. 20. School of Science, RMIT University, Melbourne, Victoria, Australia. 21. Department of Psychology, The University of Melbourne, Parkville, Victoria, Australia. 22. Faculty of Health, Deakin University, Bundoora, Victoria, Australia. 23. Department of Health Science and Biostatistics, Swinburne University of Technology, Melbourne, Victoria, Australia. 24. School of Psychology, Faculty of Science, Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), University of Sydney, Sydney, New South Wales, Australia.
Abstract
BACKGROUND: Active surveillance (AS) is the disease management option of choice for low-risk prostate cancer. Despite this, men with low-risk prostate cancer (LRPC) find management decisions distressing and confusing. We developed Navigate, an online decision aid to help men and their partners make management decisions consistent with their values. The aims are to evaluate the impact of Navigate on uptake of AS; decision-making preparedness; decisional conflict, regret and satisfaction; quality of illness communication; and prostate cancer-specific quality of life and anxiety. In addition, the healthcare cost impact, cost-effectiveness and patterns of use of Navigate will be assessed. This paper describes the study protocol. METHODS:Three hundred four men and their partners are randomly assigned one-to-one to Navigate or to the control arm. Randomisation is electronically generated and stratified by site. Navigate is an online decision aid that presents up-to-date, unbiased information on LRPC tailored to Australian men and their partners including each management option and potential side-effects, and an interactive values clarification exercise. Participants in the control arm will be directed to the website of Australia's peak national body for prostate cancer. Eligible patients will be men within 3 months of being diagnosed with LRPC, aged 18 years or older, and who are yet to make a treatment decision, who are deemed eligible for AS by their treating clinician and who have Internet access and sufficient English to participate. The primary outcome is self-reported uptake of AS as the first-line management option. Secondary outcomes include self-reported preparedness for decision-making; decisional conflict, regret and satisfaction; quality of illness communication; and prostate cancer-specific quality of life. Uptake of AS 1 month after consent will be determined through patient self-report. Men and their partners will complete study outcome measures before randomisation and 1, 3 and 6 months after study consent. DISCUSSION: The Navigate online decision aid has the potential to increase the choice of AS in LRPC, avoiding or delaying unnecessary radical treatments and associated side effects. In addition, Navigate is likely to reduce patients' and partners' confusion and distress in management decision-making and increase their quality of life. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry ACTRN12616001665426 . Registered on 2 December 2016. All items from the WHO Trial Registration Data set can be found in this manuscript.
RCT Entities:
BACKGROUND: Active surveillance (AS) is the disease management option of choice for low-risk prostate cancer. Despite this, men with low-risk prostate cancer (LRPC) find management decisions distressing and confusing. We developed Navigate, an online decision aid to help men and their partners make management decisions consistent with their values. The aims are to evaluate the impact of Navigate on uptake of AS; decision-making preparedness; decisional conflict, regret and satisfaction; quality of illness communication; and prostate cancer-specific quality of life and anxiety. In addition, the healthcare cost impact, cost-effectiveness and patterns of use of Navigate will be assessed. This paper describes the study protocol. METHODS: Three hundred four men and their partners are randomly assigned one-to-one to Navigate or to the control arm. Randomisation is electronically generated and stratified by site. Navigate is an online decision aid that presents up-to-date, unbiased information on LRPC tailored to Australian men and their partners including each management option and potential side-effects, and an interactive values clarification exercise. Participants in the control arm will be directed to the website of Australia's peak national body for prostate cancer. Eligible patients will be men within 3 months of being diagnosed with LRPC, aged 18 years or older, and who are yet to make a treatment decision, who are deemed eligible for AS by their treating clinician and who have Internet access and sufficient English to participate. The primary outcome is self-reported uptake of ASas the first-line management option. Secondary outcomes include self-reported preparedness for decision-making; decisional conflict, regret and satisfaction; quality of illness communication; and prostate cancer-specific quality of life. Uptake of AS 1 month after consent will be determined through patient self-report. Men and their partners will complete study outcome measures before randomisation and 1, 3 and 6 months after study consent. DISCUSSION: The Navigate online decision aid has the potential to increase the choice of AS in LRPC, avoiding or delaying unnecessary radical treatments and associated side effects. In addition, Navigate is likely to reduce patients' and partners' confusion and distress in management decision-making and increase their quality of life. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry ACTRN12616001665426 . Registered on 2 December 2016. All items from the WHO Trial Registration Data set can be found in this manuscript.
Entities:
Keywords:
Active surveillance; Decision aid; Distress; Low-risk prostate cancer; Management decision; Quality of life; RCT; Treatment decision
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