Navigate: a study protocol for a randomised controlled trial of an online treatment decision aid for men with low-risk prostate cancer and their partners

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.

Co‐designing an online treatment decision aid for men with low‐risk prostate cancer: Navigate

“…The quality of the Navigate OTDA will likely be further enhanced by fieldtesting with users facing treatment decisions for LRPC, which is occurring in the current RCT of the OTDA. 30 The management of low and intermediate risk PC is a fast-moving field. In the period of time during which Navigate has been developed, AS is increasingly being used for favourable intermediate-risk PC.…”

“…Navigate continues to be updated with new research evidence and other relevant information as it becomes available. The quality of the Navigate OTDA will likely be further enhanced by field‐testing with users facing treatment decisions for LRPC, which is occurring in the current RCT of the OTDA 30 …”

“…In the period of time during which Navigate has been developed, AS is increasingly being used for favourable intermediate‐risk PC 31 . While Navigate was initially designed with and for men with LRPC, it is equally relevant for men with intermediate risk PC, and this cohort of men is included in the current RCT 30 …”

“…First, some quality criteria relating to the evaluation of Navigate have not yet been assessed, thus were not included in the quality score calculation. These items will be applied pending results from the randomised controlled trial (RCT) that nearing completion 30 . Second, Anglo‐Australians were over‐represented amongst the consumer representatives; therefore, consumer recommendations cannot be considered representative of all potential users.…”

A Qualitative Study of Men’s Experiences Using Navigate: A Localized Prostate Cancer Treatment Decision Aid

“…14 The Navigate DA Web site was created to assist Australian men with LPC make informed decisions about their treatment. 15 Navigate was co-designed by a multidisciplinary team and consumers, is theoretically driven, and complies with the International Patient Decision Aid Standards (IPDAS). 13 It presents current, unbiased information in various formats including written articles, graphical tables, video presentations of men's treatment decision-making processes, and their experiences relating to their chosen treatment (e.g., side effects) as well as an interactive values clarification exercise (VCE) to help men understand how their preferences and values align with the treatment options (see Supplementary Material).…”