FACILITATING INFORMED DECISIONS ABOUT BRCA1 TESTING

乳腺癌易感基因的鉴定是最近的一项研究。 现象。事实上，自本申请书首次提交以来， 第二个乳腺癌易感基因BRCA2被鉴定出来。许多 随着基因检测成为临床标准，问题必须得到回答 练习一下。女性需要什么信息才能做出明智的决定 关于测试？什么是心理和心理社会的影响？ 乳腺癌、卵巢癌患者BRCA1/BRCA2检测及临床意义 亲戚呢？自从这个项目的工作开始以来，我们已经收集了宝贵的 关于以下方面的态度、信念和信息需求的信息 BRCA1和BRCA2测试。一项干预试验，使用量身定做的知情 第一年制定的同意信息和日常护理知情同意 正在顺利进行中。所有受试者都将被确定为处于兴奋状态 基于家族史的BRCA1/BRCA2阳性的风险，他们将 提供基因检测。据推测，量身定做的知情人士 同意小组对乳腺癌的侵入性想法会更少， 提高了关于基因检测的知识，并更准确地感知 他们患乳腺癌的风险(仅限亲属)。准备了量身定做的材料 对于基于已知的关于该人的信息并具有 通过提供以下服务扩展卫生专业人员研究的潜力 做出决策所需的信息和测试前阶段 咨询过程。由于这方面的巨大基础设施需求 相关项目，包括同意材料、问卷工具、 一个数据库和一个基因检测设施，应计开始时间晚于 最初的计划是。然而，当我们进入第三年时，干预措施 Trial已经招募了182名家庭成员，并正在以- 一流的基础设施和员工，以及来自内部和 在我们机构之外，包括达纳-法伯癌症研究所， 北卡罗来纳州夏洛特市的长老会医院和佛罗里达医院。我们期待着 首届完成400名学习参与者招生工作 第四年。咨询、基因检测和后续工作将继续进行。 一直持续到第五年的上半年。统计分析来回答这个问题 主要研究假设将在第四年进行，并于 第五年结束，从而实现了这一计划的所有原定目标 学习。我们相信，这项研究将有助于改进决策。 关于BRCA1/BRCA2测试和更好地了解 乳腺癌基因检测的心理社会影响。

The identification of breast cancer susceptibility genes is a recent phenomena. In fact, since the initial submission of this application a second breast cancer susceptibility gene, BRCA2, was identified. Many questions must be answered, as genetic testing becomes standard clinical practice. What information do women need to make an informed decision about testing? What is the psychological and psychosocial impact of BRCA1/BRCA2 testing on breast and ovarian cancer patients and their relatives? Since work on this project began, we have assembled valuable information concerning the attitudes, beliefs and information needs about BRCA1 and BRCA2 testing. An intervention trial, using Tailored Informed Consent Information and Usual Care Informed Consent developed in year one is well underway. All subjects will have been determined to be at high risk of BRCA1/BRCA2 positive based on family history, and they will be offered genetic testing. It is hypothesized that the Tailored Informed Consent group will have fewer intrusive thoughts about breast cancer, improved knowledge about genetic testing, and more accurate perception of their breast cancer risk (relatives only). Tailored materials are prepared for an individual based on information known about that person and have the potential to extend the research of health professional by providing information needed to make decisions and the pre-test phase of the counseling process. Due to the vast infrastructure needs for this and related projects, including consent materials, questionnaire instruments, a database, and a genetic testing facility, accrual began later than initially planned. However, as we entered year three, the intervention trial has enrolled 182 family members and is operating with a state-of- the-art infrastructure and staff as well as referral base from within and outside our institution, including the Dana-Farber Cancer Institute, Presbyterial Hospital in Charlotte, NC and Florida Hospital. We anticipate the completion of the enrollment of 400 study participants in the first year of year four. Counseling, genetic testing and follow-up will continue through the first half of year five. Statistical analyses to answer the main study hypotheses will be in progress in year four and completed by the end of year five, thus accomplishing all the original aims of this study. We believe that this research will lead to improved decision-making concerning BRCA1/BRCA2 testing and a better understanding of the psychosocial impact of genetic testing for breast cancer.