An Online Treatment Decision Aid for Men with Low-risk Prostate Cancer Eligible for Active Surveillance and Their Partners Increases the Uptake of Active Surveillance: The Navigate Randomised Controlled Trial

Evidence suggests that curative treatment for low-risk prostate cancer (LRPC) has no survival benefits over active surveillance (AS); thus, treatment choice becomes a value-sensitive decision. Decision aids (DAs) have the potential to facilitate this process, yet no DA has been tailored to the Australian health care system or population. This study aims to evaluate the impact of an online DA (Navigate) on the uptake of AS, quality of life, and decision-making in Australia. This parallel-group, prospective, randomised controlled trial recruited men (from May 2017 to May 2021) from participating cancer centres, via self-referral, or via clinician referral. The inclusion criteria were the following: a recent LRPC diagnosis, no decision on treatment, and clinical suitability for AS. Partners could also enrol. Assessments were undertaken at baseline (before decision) and after baseline (1, 2, and 6 mo). Participants were randomised 1:1 to Navigate (online DA, intervention) or a national prostate cancer website (usual care), stratified by the site/recruitment method. Partners were allocated to the group matching their respective partners. The primary outcome was self-reported uptake of AS for first-line treatment at 1 mo. The secondary outcomes included decision-making preparedness; decisional conflict, regret, and satisfaction; illness communication; and prostate cancer-specific quality of life. Intention-to-treat analyses were conducted. Of the 619 patients referred, those eligible (n = 302) were randomised to either Navigate (n = 153) or usual care (n = 149), with no significant between-group differences at baseline. The proportion of men self-reporting AS versus another treatment was 90.6% (Navigate) versus 79.0% (usual care; p = 0.008). Navigate participants also reported greater decision-making preparedness (p < 0.001). Partners were allocated to Navigate (n = 70) or usual care (n = 49); no significant between-group differences were found. Longer-term outcomes were not measured. Providing men with an online DA resulted in higher uptake of AS for LRPC than standard resources and in increased decision-making preparedness. By increasing the uptake of AS, DAs may help reduce treatment-related morbidity. Implementation research assessing the possibility of integrating Navigate into standard care is needed.