INTERNET DECISION SUPPORT FOR BRCA1/BRCA2 CARRIERS

描述(申请人提供)：BRCA1和BRCA2(BRCA1/2)突变的基因检测已成为有乳腺癌或卵巢癌家族史的女性的常规临床护理的一部分。携带BRCA1/2突变的女性一生中患乳腺癌和卵巢癌的风险更高。管理指南包括密切监测或考虑降低乳房和卵巢切除术的风险。尽管这些手术方法显著降低了相关癌症的风险，但许多携带者不愿选择这些策略。考虑到这些高度重要的决定的复杂和情绪性，许多运营商报告对他们收到的关于这些决定的信息和咨询感到不满也就不足为奇了。此外，他们经常将管理决策列为BRCA1/2测试中压力最大的方面之一。这项研究的目的是评估潜在的可传播干预措施的有效性，以帮助患者做出与他们的偏好一致的知情和执行的管理决定。为了实现这一点，将评估传统印刷信息、基于网络的信息和决策辅助工具(DA)的效果，这些信息也是通过网络以印刷和交互方式提供的。DA已被证明在帮助患者做出复杂的医疗决定方面是有效的。虽然已经为BRCA1/2携带者开发了几种DA，但很少有在随机试验中进行测试。因此，在这项大型多点试验中，将采用2×2随机析因设计，在BRCA1/2结果呈阳性的女性临床人群中评估干预(仅提供信息与信息+DA)和交付方式(网络与印刷)的有效性和成本效益。将评估多种患者的结果，包括使用降低风险的手术、与健康相关的生活质量和痛苦。此外，还将确定干预措施对患者结局的影响机制，以及最有可能和最不可能从干预措施中受益的个人的特征和预测因素，并利用网络和印刷材料。这项创新研究的结果不仅与越来越多的BRCA1/2携带者有关，而且随着“个性化医疗”变得越来越普遍，也将与其他人群相关。还将评估有关如何最好地针对灾难援助和基于网络的干预措施的潜在优势的重要问题。公共卫生相关性：这项研究的目的是评估印刷品和基于网络的干预措施的临床有效性，这些干预措施为携带BRCA1/2突变的妇女提供信息和决策支持。通过促进知情决策，希望这些高危妇女将实施乳腺癌和卵巢癌风险管理决策，对她们的福祉和生活质量产生积极影响，并最终降低这些癌症的发病率和死亡率。

DESCRIPTION (provided by applicant): Genetic testing for BRCA1 and BRCA2 (BRCA1/2) mutations has become part of routine clinical care for women with a strong family history of breast or ovarian cancer. Women who carry a BRCA1/2 mutation have elevated lifetime risks of developing breast and ovarian cancer. Management guidelines consist of intensive surveillance or consideration of risk reducing mastectomy and oophorectomy. Although these surgical approaches significantly reduce the risk of associated cancers, many carriers are reluctant to choose these strategies. Given the complex and emotional nature of these highly consequential decisions, it is not surprising that many carriers report dissatisfaction with the information and counseling they have received regarding these decisions. Moreover, they often rate management decision making as one of the most stressful aspects of BRCA1/2 testing. The goal of this study is to evaluate the effectiveness of potentially disseminable interventions to help patients make well- informed, and implemented, management decisions that are consistent with their preferences. In order to accomplish this, the effects of traditional print information, web- based information, and a decision aid (DA) also delivered in print and interactively via the web will be assessed. DAs have been shown to be effective in helping patients make complex medical decisions. Although several DAs have been developed for BRCA1/2 carriers, few have been tested in randomized trials. Thus, in this large multi-site trial, a 2 X 2 randomized factorial design will be employed to evaluate both the effectiveness and cost effectiveness of the intervention (information only vs. information + DA) and delivery mode (web vs. print) within a clinical population of women receiving positive BRCA1/2 results. Multiple patient outcomes, including utilization of risk reducing surgery, health related quality of life, and distress will be assessed. In addition, the mechanisms by which the interventions impact on patient outcomes as well as characteristics and predictors of individuals most and least likely to benefit from the interventions and to utilize the web and print materials will be identified. The findings from this innovative research will be relevant not only to the increasing numbers of identified BRCA1/2 carriers, but also to other populations as "personalized medicine" becomes more widespread. Important questions about how to best target DAs and the potential advantages of web-based interventions will also be evaluated. PUBLIC HEALTH RELEVANCE: The purpose of this study is to assess the clinical effectiveness of print and web based interventions that provide information and decision support to women who have BRCA1/2 mutations. By facilitating informed decision making, it is hoped that these high risk women will implement breast and ovarian cancer risk management decisions that have positive effects on their well being and quality of life, and which ultimately reduce morbidity and mortality from these cancers.