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.

IF 8.3 1区 医学 Q1 ONCOLOGY
Penelope Schofield, Stephen Quinn, Natalie Richards, Alan White, Fiona White, Mark Frydenberg, Suzanne Chambers, Louisa G Gordon, Robert Alexander 'Frank' Gardiner, Declan G Murphy, Matthew J Roberts, John Yaxley, Nathan Lawrentschuk, Kevin Chu, Jeremy Millar, Jeremy Grummet, Ilona Juraskova
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引用次数: 0

Abstract

Background and objective: 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.

Methods: 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.

Key findings and limitations: 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.

Conclusions and clinical implications: 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.

适合主动监测的低风险前列腺癌患者及其伴侣的在线治疗决策辅助增加了主动监测的吸收:导航随机对照试验
背景和目的:有证据表明,低危前列腺癌(LRPC)的根治性治疗与主动监测(AS)相比没有生存益处;因此,治疗选择成为一个价值敏感的决策。决策辅助(DAs)有可能促进这一进程,但还没有为澳大利亚卫生保健系统或人口量身定制的DA。本研究旨在评估在线DA(导航)对澳大利亚AS的吸收、生活质量和决策的影响。方法:该平行组、前瞻性、随机对照试验通过自我推荐或临床医生推荐从参与的癌症中心招募男性(2017年5月至2021年5月)。纳入标准如下:近期LRPC诊断,未决定治疗,临床适合AS。合伙人也可以报名参加。在基线(决策前)和基线后(1、2和6个月)进行评估。参与者按1:1随机分配到导航(在线DA,干预)或国家前列腺癌网站(常规护理),按现场/招募方法分层。合伙人被分配到与其各自的合伙人相匹配的小组。主要结局是在1个月时接受一线治疗的AS的自我报告。次要结局包括决策准备;决策冲突、后悔和满足;疾病的沟通;前列腺癌特有的生活质量。进行意向治疗分析。主要发现和局限性:在619例患者中,符合条件的患者(n = 302)被随机分配到导航组(n = 153)或常规治疗组(n = 149),基线时组间无显著差异。男性自我报告AS与其他治疗的比例为90.6%(导航)对79.0%(常规护理;p = 0.008)。导航参与者还报告了更大的决策准备(p结论和临床意义:为男性提供在线DA导致LRPC的AS吸收高于标准资源,并且增加了决策准备。通过增加AS的摄取,DAs可能有助于减少治疗相关的发病率。需要实施研究,评估将导航纳入标准护理的可能性。
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来源期刊
CiteScore
15.50
自引率
2.40%
发文量
128
审稿时长
20 days
期刊介绍: Journal Name: European Urology Oncology Affiliation: Official Journal of the European Association of Urology Focus: First official publication of the EAU fully devoted to the study of genitourinary malignancies Aims to deliver high-quality research Content: Includes original articles, opinion piece editorials, and invited reviews Covers clinical, basic, and translational research Publication Frequency: Six times a year in electronic format
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