Bridging Geographic Barriers: Remote Cancer Genetics Counseling for Rural Women

描述（由申请人提供）：生活在农村和其他地理服务不足地区的人遇到相当大的障碍，减少或阻止方便地获得高质量的癌症遗传服务。由癌症遗传学专家为适当选择的妇女提供面对面的遗传咨询已被普遍接受为护理标准。有人建议利用电信在远离专家的地点提供临床遗传服务，作为减少地理条件恶劣地区获得服务机会不均等的一种办法。远程遗传咨询有可能通过获得信息和与有经验的提供者沟通来改善健康和加强知情决策，而不会对护理质量产生不利影响。虽然电话咨询已被有效地用于补充人的遗传服务，没有公布的数据比较电话遗传咨询作为唯一的来源，测试前和测试后的披露咨询，标准的人的遗传咨询的高风险妇女。然而，许多公司和一些供应商正在提供基于电话的遗传咨询和癌症易感性测试服务。许多临床医生和政策制定者都关心这种咨询的质量，以及通过电话进行的咨询是否和标准的面对面咨询一样有效。在广泛采用和传播电话提供的癌症遗传服务之前，重要的是要确定这种遗传沟通模式是否与传统的面对面咨询模式相媲美，在远程咨询可能受益最大的群体中，居住在农村和其他服务不足地区的妇女。这项两组随机等效性/非劣效性试验旨在确定通过电话提供的遗传咨询是否是传统面对面遗传咨询的可接受替代方案，该试验在1132名地理隔离的女性中进行，这些女性具有足够强的乳腺癌和/或卵巢癌个人和/或家族史，表明需要进行遗传咨询和检测。我们将评估以下结果：基因检测吸收，心理困扰和健康相关的生活质量。我们还将比较两组在成本，以患者为中心的沟通，知情的决策结果，如决策冲突，决策后悔和感知的个人控制以及有关预防策略的决定。总的来说，我们的研究结果将为癌症中心和当地公共卫生决策者提供重要信息，这些信息涉及为有BRCA 1/2突变风险的农村妇女提供基于电话的临床癌症遗传服务的安全性，有效性和成本。公共卫生相关性：减少农村卫生差距是国家的优先事项。我们的研究是创新的，因为我们的方法在为遗传性乳腺癌和卵巢癌风险增加的地理服务不足的妇女提供远程癌症遗传服务方面是前所未有的。许多将要评估的结果对于确定电话遗传咨询是否是传统面对面咨询的合理替代方案非常重要。研究的结果包括焦虑，癌症担忧，生活质量，知情决策，成本以及BRCA 1/2基因检测和癌症预防策略的利用。在广泛使用电话提供的临床癌症遗传咨询服务之前，关键是要确定在最有可能使用这些服务的人群中，疗效和安全性是否会受到相当大的影响。我们的研究结果可用于为农村和其他偏远地区的临床实践以及癌症控制政策提供信息。

DESCRIPTION (provided by applicant): Persons living in rural and other geographically underserved areas encounter considerable barriers that reduce or prevent convenient access to quality cancer genetic services. In-person genetic counseling for appropriately selected women by cancer genetic specialists has generally been accepted as the standard of care. The use of telecommunications to deliver clinical genetic services at a site distant from specialists has been suggested as an approach to reduce disparity in access in geographically challenged areas. Remote genetic counseling has the potential to improve health and enhance informed decision-making through access to information and communication with experienced providers without adversely affecting the quality of care. Although telephone counseling has been effectively used as a supplement to in-person genetic services, no published data are available that compare telephone genetic counseling as the sole source of pre-test and post-test disclosure counseling to standard in-person genetic counseling among high-risk women. However, many companies and some providers are offering telephone-based genetic counseling and testing services for cancer susceptibility. Many clinicians and policy makers are concerned about the quality of such counseling and whether counseling conducted over the telephone is as effective as standard in- person counseling. Before widespread adoption and diffusion of telephone-delivered cancer genetic services, it is important to determine whether this mode of genetic communication is comparable to the conventional in-person counseling model within the group where remote counseling is likely to be of greatest benefit, women residing in rural and other underserved areas. This two-group randomized equivalency/non-inferiority trial is designed to determine if genetic counseling delivered by telephone is an acceptable alternative to traditional in-person genetic counseling among 1132 geographically isolated women who have a personal and/or family history of breast and/or ovarian cancer strong enough to suggest that genetic counseling and testing is indicated. We will evaluate the following outcomes: genetic testing uptake, psychological distress, and health-related quality of life. We will also compare the two groups with regard to costs, patient centered communication, and informed decision- making outcomes such as decisional conflict, decision regret and perceived personal control as well as decisions regarding preventive strategies. Overall, our study's findings will provide important information to cancer centers and local public health decision makers about the safety, efficacy, and costs of delivering telephone-based clinical cancer genetic services for rural women at risk for having BRCA 1/2 mutations. PUBLIC HEALTH RELEVANCE: Reducing rural health disparities is a national priority. Our study is innovative in that our approach is unprecedented with regard to provision of remote cancer genetic services to geographically underserved women at increased risk for hereditary breast and ovarian cancer. Many of the outcomes that will be evaluated are important for determining whether telephone- delivered genetic counseling sessions are a reasonable alternative to conventional face-to-face counseling. Outcomes studied include anxiety, cancer worry, quality of life, informed-decision making, costs, as well as utilization of BRCA1/2 gene testing and cancer prevention strategies. Prior to widespread use of telephone-delivered clinical cancer genetic counseling services, it is critical to determine whether efficacy and safety are considerably compromised in a population that is most likely to use these services. Our study's findings may be used to inform clinical practice in rural and other remote areas as well as cancer control policy.