FACILITATING INFORMED DECISIONS ABOUT BRCA1 TESTING

乳腺癌易感基因(BRCA1)是新近发现的。在……里面 在不久的将来，检测乳腺癌和/或卵巢癌将成为可能 患者及其一级亲属为BRCA1的存在。许多 在BRCA1检测成为临床标准之前，必须回答问题 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？如何才能最好地提供这些信息？什么是 BRCA1检测对乳腺癌患者的心理和社会心理影响 病人和他们的一级亲属？这项拟议的研究旨在 回答这些问题。在我们研究计划的开发阶段， 焦点小组将与乳腺癌患者和他们的第一个 学位亲属。关于BRCA1的态度、信念和信息需求 将对测试进行评估。将举行更多焦点小组会议， 接受过其他疾病基因检测的个人。这个 在焦点小组中获得的数据将用于制定量身定做的 考虑进行BRCA1检测的妇女的知情同意信息。在 干预阶段，将进行一项随机试验，比较 定制的知情同意信息(TICI)和常规护理 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做 女人。共有400名乳腺癌和/或卵巢癌患者和他们的 家庭成员将被累加。所有受试者都将被决定 基于家族病史的BRCA1阳性的高风险，他们会 接受BRCA1测试。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， 提高了对BRCA1测试的了解，并获得了更准确的感知 他们患乳腺癌的风险(仅限亲属)。在BRCA1测试之后， 研究参与者将在1个月和6个月时重新评估，以评估 检测和健康行为变化的心理社会后果。我们 相信这项研究将导致决策的改进 关于BRCA1测试和更好地理解心理社会 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.