INTERNET DECISION SUPPORT FOR BRCA1/BRCA2 CARRIERS

描述（由申请人提供）：BRCA1和BRCA2 （BRCA1/2）突变基因检测已成为有乳腺癌或卵巢癌家族史的女性常规临床护理的一部分。携带BRCA1/2基因突变的女性一生中患乳腺癌和卵巢癌的风险更高。管理指南包括加强监测或考虑降低风险的乳房切除术和卵巢切除术。尽管这些手术方式显著降低了相关癌症的风险，但许多携带者不愿意选择这些策略。考虑到这些重大决定的复杂性和情感性质，许多运营商对他们收到的有关这些决定的信息和咨询表示不满也就不足为奇了。此外，他们通常认为管理决策是BRCA1/2检测中压力最大的方面之一。本研究的目的是评估潜在的可推广干预措施的有效性，以帮助患者做出充分了解和实施符合其偏好的管理决策。为了实现这一目标，将评估传统印刷信息、基于网络的信息以及以印刷形式和通过网络交互方式提供的决策辅助（DA）的效果。DAs在帮助病人做出复杂的医疗决定方面已被证明是有效的。尽管已经为BRCA1/2携带者开发了几种da，但很少在随机试验中进行测试。因此，在这项大型多地点试验中，将采用2 × 2随机因子设计，在BRCA1/2阳性结果的女性临床人群中评估干预（仅信息vs信息+ DA）和递送模式（网络vs印刷品）的有效性和成本效益。多种患者结果，包括使用降低风险的手术，健康相关的生活质量和痛苦将被评估。此外，将确定干预措施对患者结果的影响机制，以及最有可能和最不可能从干预措施中受益的个体的特征和预测因素，并利用网络和印刷材料。这项创新研究的发现不仅与越来越多的BRCA1/2携带者相关，而且随着“个性化医疗”的普及，也将与其他人群相关。还将评估关于如何最好地针对发展中国家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：本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BRCA1/2突变妇女提供信息和决策支持。通过促进知情决策，希望这些高风险妇女能够实施乳腺癌和卵巢癌风险管理决策，对她们的健康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.