INTERNET DECISION SUPPORT FOR BRCA1/BRCA2 CARRIERS

BRCA1/BRCA2 运营商的互联网决策支持

• 批准号: 8267060
• 负责人: Marc D Schwartz
• 金额: $ 42.13万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-07-01 至 2014-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8267060
• 关键词: Address; Age; BRCA1 Mutation; BRCA1 gene; BRCA2 Mutation; BRCA2 gene; Body Image; Cancer Patient; Caring; Characteristics; Charge; Child; Clinical; Clinical Trials; Clinical effectiveness; Complex; Comprehensive Cancer Center; Conflict (Psychology); Counseling; Decision Aid; Decision Making; Distress; Effectiveness; Effectiveness of Interventions; Emotional; Expert Opinion; Family history of; Genetic; Genetic Counseling; Genetic Programming; Genetic screening method; Goals; Guidelines; Health; High Risk Woman; Individual; Institutes; Internet; Intervention; Knowledge; Lead; Malignant Neoplasms; Malignant neoplasm of ovary; Mastectomy; Materials Testing; Mediating; Medical; Medicine; Menopausal Symptom; Morbidity - disease rate; Nature; Online Systems; Operative Surgical Procedures; Outcome; Ovariectomy; Participant; Patient Education; Patients; Persons; Piper; Population; Printing; Quality of life; Randomized; Regrets; Relative (related person); Reporting; Research; Risk; Risk Management; Sampling; Sexuality; Technology; Test Result; Testing; Time; Virginia; Woman; arm; base; cancer risk; child bearing; clinical care; clinical practice; cost; cost effectiveness; design; follow-up; health literacy; health related quality of life; improved; innovation; intervention effect; lifetime risk; malignant breast neoplasm; medical schools; mortality; multi-site trial; mutation carrier; preference; primary outcome; psychosocial; randomized trial; satisfaction; tool; uptake

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.

描述（由申请人提供）：BRCA1和BRCA2（BRCA1/2）的基因测试已成为具有较强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突变的女性患乳腺癌和卵巢癌的终生风险升高。管理指南包括密集监视或考虑降低乳房切除术和卵巢切除术的风险。尽管这些手术方法大大降低了相关癌症的风险，但许多载体不愿选择这些策略。鉴于这些高度结果决定的复杂和情感性质，许多载体报告对他们对这些决定的信息和咨询的不满，这并不奇怪。此外，他们通常将管理决策评为BRCA1/2测试最紧张的方面之一。这项研究的目的是评估潜在的可见干预措施的有效性，以帮助患者做出符合其偏好一致的知情和实施的管理决策。为了实现这一目标，将评估传统印刷信息，基于Web的信息以及通过Web进行印刷和互动交付的决策援助（DA）的影响。 DAS已被证明可以有效地帮助患者做出复杂的医疗决策。尽管已经为BRCA1/2载体开发了多个DA，但在随机试验中很少进行测试。因此，在这项大型多站点试验中，将采用2 x 2的随机阶乘设计来评估干预措施（仅信息与信息 + DA）和输送模式（Web vs. Print）的有效性和成本有效性（在接受BRCA1/2结果阳性的妇女人群中）。将评估多种患者结局，包括降低手术的风险，与健康相关的生活质量和困扰。此外，将确定干预措施对患者结果的影响以及最可能受益于干预措施并利用网络和印刷材料的个体的特征和预测因素的机制。这项创新研究的发现不仅与越来越多的已确定的BRCA1/2载体有关，而且还与其他人群有关，因为“个性化医学”变得更加普遍。还将评估有关如何最佳针对DA的重要问题以及基于Web的干预措施的潜在优势。公共卫生相关性：本研究的目的是评估基于印刷和网络的干预措施的临床有效性，这些干预措施为患有BRCA1/2突变的妇女提供信息和决策支持。通过促进明智的决策，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，这些决策对其良好的生活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。