Department of Psychology, Swinburne University of Technology, Melbourne, Victoria, Australia.
Behavioural Science Unit, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
Trials. 2021 Jan 11;22(1):49. doi: 10.1186/s13063-020-04986-9.
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.
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.
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.
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.
主动监测（AS）是低危前列腺癌的首选疾病管理方案。尽管如此，患有低危前列腺癌（LRPC）的男性发现管理决策令人痛苦和困惑。我们开发了 Navigate，这是一种在线决策辅助工具，可帮助男性及其伴侣做出符合其价值观的管理决策。目的是评估 Navigate 对 AS 采用率的影响；决策准备情况；决策冲突、遗憾和满意度；疾病沟通质量；以及前列腺癌特异性生活质量和焦虑。此外，还将评估 Navigate 的医疗保健成本影响、成本效益和使用模式。本文介绍了研究方案。
304 名男性及其伴侣被随机分为一对一的 Navigate 组或对照组。随机分组是通过电子方式生成的，并按地点分层。Navigate 是一种在线决策辅助工具，它提供了针对澳大利亚男性及其伴侣的最新、无偏见的 LRPC 信息，包括每种管理选项和潜在的副作用，以及互动的价值观澄清练习。对照组中的参与者将被引导至澳大利亚前列腺癌最高国家机构的网站。符合条件的患者是在被诊断患有 LRPC 后 3 个月内的男性，年龄在 18 岁或以上，尚未做出治疗决策，他们的治疗医生认为他们适合接受 AS，并且有互联网访问权限和足够的英语水平来参与。主要结果是自我报告的 AS 作为一线管理选择的采用率。次要结果包括自我报告的决策准备情况；决策冲突、遗憾和满意度；疾病沟通质量；以及前列腺癌特异性生活质量。同意后 1 个月将通过患者自我报告确定 AS 的采用率。男性及其伴侣将在随机分组前、研究同意后 1、3 和 6 个月完成研究结果测量。
Navigate 在线决策辅助工具有可能增加 LRPC 中 AS 的选择，避免或延迟不必要的激进治疗和相关副作用。此外，Navigate 可能会减少患者和伴侣在管理决策中的困惑和困扰，并提高他们的生活质量。
澳大利亚和新西兰临床试验注册中心 ACTRN12616001665426。于 2016 年 12 月 2 日注册。WHO 试验注册数据集中的所有项目都可以在本文中找到。
