FACILITATING INFORMED DECISIONS ABOUT BRCA1 TESTING

乳腺癌易感基因（BRCA 1）最近被发现。在 在不久的将来，检测乳腺癌和/或卵巢癌将成为可能。 患者及其一级亲属是否存在BRCA 1。许多 在BRCA 1检测成为标准临床检测之前， 实践女性需要哪些信息来做出明智的决定 关于测试？如何才能最好地提供这种信息？是什么 BRCA 1检测对乳腺癌的心理和社会心理影响 患者及其一级亲属？ 拟议的研究旨在 回答这些问题在我们研究项目的开发阶段， 焦点小组将与乳腺癌患者和他们的第一次 度亲属。关于BRCA 1的态度、信念和信息需求 测试将被评估。将举行更多的焦点小组会议， 接受过其他疾病基因检测的人。的 在焦点小组中获得的数据将用于制定一个量身定制的 考虑BRCA 1检测的女性的知情同意信息。在 干预阶段，将进行一项随机试验，比较 定制的知情同意书（TICI），包括患者护理知情 知情同意信息（UICI）。UICI材料将审查所有必要的 知情同意的各个方面，但不会为个人量身定制 女人总共有400名乳腺癌和/或卵巢癌患者及其 家庭成员将增加。所有受试者将被确定为 根据家族史，BRCA 1阳性的风险很高，他们将 进行BRCA 1检测。据推测， 同意组对乳腺癌的侵入性想法会更少， 提高对BRCA 1检测的认识， 患乳腺癌的风险（仅限亲属）。在BRCA 1检测之后， 研究参与者将在一个月和六个月时重新评估， 测试的心理社会后果和健康行为的变化。我们 我相信这项研究将有助于改善决策 关于BRCA 1测试和更好地了解心理社会 基因检测对乳腺癌的影响

The breast cancer susceptibility gene (BRCA1) was recently identified. In the near future, it will be possible to test breast and/or ovarian cancer patients and their first degree relatives for the presence of BRCA1. Many questions must be answered before BRCA1 testing becomes standard clinical practice. What information do women need to make an informed decision about testing? How can this information best be provided? What is the psychological and psychosocial impact of BRCA1 testing on breast cancer patients and their first degree relatives? The proposed research seeks to answer these questions. In the Development Phase of our research program, focus groups will be held with breast cancer patients and their first degree relatives. Attitudes, beliefs, and information needs about BRCA1 testing will be assessed. Additional focus groups will be held with individuals who have undergone genetic testing for other disorders. The data obtained in the focus groups will be used in developing a Tailored Informed Consent information for women considering BRCA1 testing. In the Intervention Phase, a randomized trial will be conducted comparing the Tailored informed Consent information (TICI) with Usual Care Informed Consent information (UICI). The UICI materials will review all essential aspects of informed consent but will not be tailored for the individual woman. A total of 400 breast and/or ovarian cancer patients and their family members will be accrued. All subjects will have been determined to be at high risk of BRCA1 positivity based on family history, and they will be offered BRCA1 testing. it is hypothesized that the Tailored Informed Consent group will have fewer intrusive thoughts about breast cancer, improved knowledge about of BRCA1 testing, and a more accurate perception of their breast cancer risk (relatives only). Following BRCA1 testing, study participants will be re-assessed at one and six months to assess the psychosocial consequences of testing and changes in health behavior. We believe that this research will lead to improved decision-making concerning BRCA1 testing and a better understanding of the psychosocial impact of genetic testing for breast cancer.