Knerr Sarah, Wernli Karen J, Leppig Kathleen, Ehrlich Kelly, Graham Amanda L, Farrell David, Evans Chalanda, Luta George, Schwartz Marc D, O'Neill Suzanne C
Group Health Research Institute, Seattle, WA 98101, USA(1).
Group Health Research Institute, Seattle, WA 98101, USA(1).
Contemp Clin Trials. 2017 May;56:25-33. doi: 10.1016/j.cct.2017.02.009. Epub 2017 Feb 28.
Mammographic breast density is one of the strongest risk factors for breast cancer after age and family history. Mandatory breast density disclosure policies are increasing nationally without clear guidance on how to communicate density status to women. Coupling density disclosure with personalized risk counseling and decision support through a web-based tool may be an effective way to allow women to make informed, values-consistent risk management decisions without increasing distress.
METHODS/DESIGN: This paper describes the design and methods of Engaged, a prospective, randomized controlled trial examining the effect of online personalized risk counseling and decision support on risk management decisions in women with dense breasts and increased breast cancer risk. The trial is embedded in a large integrated health care system in the Pacific Northwest. A total of 1250 female health plan members aged 40-69 with a recent negative screening mammogram who are at increased risk for interval cancer based on their 5-year breast cancer risk and BI-RADS® breast density will be randomly assigned to access either a personalized web-based counseling and decision support tool or standard educational content. Primary outcomes will be assessed using electronic health record data (i.e., chemoprevention and breast MRI utilization) and telephone surveys (i.e., distress) at baseline, six weeks, and twelve months.
Engaged will provide evidence about whether a web-based personalized risk counseling and decision support tool is an effective method for communicating with women about breast density and risk management. An effective intervention could be disseminated with minimal clinical burden to align with density disclosure mandates. Clinical Trials Registration Number:NCT03029286.
乳腺钼靶密度是除年龄和家族史外最强的乳腺癌风险因素之一。全国范围内强制披露乳腺密度的政策不断增加，但在如何向女性传达密度状况方面却缺乏明确指导。通过基于网络的工具将密度披露与个性化风险咨询和决策支持相结合，可能是一种有效的方式，能让女性在不增加困扰的情况下做出明智的、符合价值观的风险管理决策。
方法/设计：本文描述了“参与”（Engaged）这一前瞻性随机对照试验的设计和方法，该试验旨在研究在线个性化风险咨询和决策支持对乳腺密度高且乳腺癌风险增加的女性风险管理决策的影响。该试验嵌入太平洋西北地区的一个大型综合医疗保健系统。共有1250名年龄在40 - 69岁、近期乳腺钼靶筛查结果为阴性、基于其5年乳腺癌风险和乳腺影像报告和数据系统（BI-RADS®）乳腺密度患间期癌风险增加的女性健康计划成员将被随机分配，以访问个性化的基于网络的咨询和决策支持工具或标准教育内容。主要结局将在基线、六周和十二个月时使用电子健康记录数据（即化学预防和乳腺MRI使用情况）和电话调查（即困扰程度）进行评估。
“参与”试验将提供证据，证明基于网络的个性化风险咨询和决策支持工具是否是与女性就乳腺密度和风险管理进行沟通的有效方法。一种有效的干预措施可以在临床负担最小的情况下进行传播，以符合密度披露要求。临床试验注册号：NCT03029286。
