Bridging Geographic Barriers: Remote Cancer Genetics Counseling for Rural Women

跨越地理障碍：为农村妇女提供远程癌症遗传学咨询

• 批准号: 8270572
• 负责人: Anita Y. Kinney
• 金额: $ 55.05万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-08-13 至 2014-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8270572
• 关键词: Access to Information; Adoption; Affect; Affective; Anxiety; Area; BRCA1 gene; Behavioral; Breast; Cancer Center; Cancer Control; Client satisfaction; Clinical; Cognitive; Communication; Conflict (Psychology); Counseling; Data; Decision Making; Diffusion; Disclosure; Distant; Distress; Enrollment; Evaluation; Family history of; Genes; Genetic; Genetic Counseling; Genetic Services; Genetic screening method; Health; Health Services Accessibility; Healthcare; Hereditary Breast Carcinoma; Hereditary Breast and Ovarian Cancer Syndrome; High Risk Woman; Intervention; Knowledge; Life; Malignant Neoplasms; Malignant neoplasm of ovary; Mediating; Modeling; Mutation; Nature; Outcome; Outcome Study; Patients; Perception; Persons; Policies; Policy Maker; Population; Pre-Post Tests; Predisposition; Prevention strategy; Provider; Psychosocial Factor; Public Health; Publishing; Quality of Care; Quality of life; Randomized; Regrets; Relative (related person); Reporting; Risk; Role; Rural; Rural Health; Safety; Secondary Prevention; Services; Site; Source; Specialist; Specific qualifier value; Telecommunications; Telephone; Testing; Time; Woman; base; cancer genetics; cancer prevention; clinical practice; cost; design; experience; health disparity; health related quality of life; improved; innovation; patient oriented; prevent; psychologic; psychological distress; randomized trial; satisfaction; standard of care; uptake

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.

描述（由申请人提供）：生活在农村和其他服务欠缺地区的人们遇到了相当大的障碍，这些障碍减少或阻碍了获得优质癌症遗传服务的便捷性。癌症遗传专家为适当选择的女性提供面对面的遗传咨询已被普遍接受为标准护理。有人建议使用电信在远离专家的地点提供临床遗传服务，作为减少地理困难地区的获取差异的一种方法。远程遗传咨询有可能通过获取信息以及与经验丰富的提供者沟通来改善健康并增强知情决策，而不会对护理质量产生不利影响。尽管电话咨询已被有效地用作面对面遗传服务的补充，但没有公布的数据可以将电话遗传咨询作为测试前和测试后披露咨询的唯一来源与高危女性中标准面对面遗传咨询进行比较。然而，许多公司和一些提供商正在提供基于电话的癌症易感性遗传咨询和测试服务。许多临床医生和政策制定者担心此类咨询的质量以及通过电话进行的咨询是否与标准的面对面咨询一样有效。在广泛采用和推广电话提供的癌症遗传服务之前，重要的是要确定这种遗传交流模式是否与居住在农村和其他服务欠缺地区的妇女群体中的传统面对面咨询模式相当，在该群体中，远程咨询可能会带来最大的益处。这项两组随机等效/非劣效性试验旨在确定，在 1132 名地理位置偏僻的女性中，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的替代方案，这些女性有乳腺癌和/或卵巢癌的个人和/或家族史，足以表明需要进行遗传咨询和检测。我们将评估以下结果：基因检测的采用率、心理困扰以及与健康相关的生活质量。我们还将比较两组的成本、以患者为中心的沟通和知情决策结果，例如决策冲突、决策后悔和感知个人控制以及有关预防策略的决策。总体而言，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，了解为有 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：减少农村健康差距是国家优先事项。我们的研究具有创新性，因为我们的方法在向地理上服务不足、遗传性乳腺癌和卵巢癌风险增加的女性提供远程癌症遗传服务方面是前所未有的。将评估的许多结果对于确定电话提供的遗传咨询课程是否是传统面对面咨询的合理替代方案非常重要。研究结果包括焦虑、癌症担忧、生活质量、知情决策、成本以及 BRCA1/2 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，确定最有可能使用这些服务的人群的有效性和安全性是否受到严重损害至关重要。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。