Comparative Effectiveness of Interventions to Increase Guideline-based Genetic Counseling in Ethnically and Geographically Diverse Cancer Survivors

遗传性乳腺癌和卵巢癌的遗传咨询或癌症遗传风险评估(CGRA) (HBOC)是一种以证据为基础的精准医学战略，有助于在知情的情况下 有效的健康管理选项。确定HBOC风险增加的个人对于 癌症幸存者及其家人受益于癌症预防、早期发现、 治疗和生存。尽管关于CGRA和基因检测的国家指南已经为 二十年来，只有三分之一或更少的高危女性获得了这些服务。最优风险 评估策略从患有HBOC相关癌症的个人开始。广泛传播和传播 需要通过知情决策和促进CGRA的国家指导方针，以实现 减少人口层面的癌症发病率、死亡率和差异。因此，促进可获得性非常重要。 到CGRA，特别是在医疗服务不足的人群中。拟议的遗传风险评估 癌症教育和赋权(GRACE)项目寻求通过以下方式解决这一重要的翻译差距 制定和实施战略，在落基山区促进以指南为基础的护理 CGRA的使用按族裔和地理分布有明显的差异。值得注意的是，很少有人 进行了干预研究，以解决CGRA的区域和国家翻译差距 利用这些不同的人群，强调我们的研究的高影响力和创新的公共卫生 干预交付方法。格蕾丝项目由循证行为改变咨询指导 促进基于风险的护理提供和减少差异的战略，考虑到个人、文化、社会 和系统层面的因素。这项研究的主要目的是测试定向邮寄的比较效果 打印(TP)与TP以及基于电话的定制咨询和导航干预(TCN)与常规护理的对比 (UC)为HBOC增加基于指南的CGRA。我们将对拉美裔和农村居民进行过抽样，并招收 1206名癌症高危女性幸存者。女性将通过科罗拉多州和新墨西哥州的癌症招募 并符合CGRA转介的标准。参赛者将被随机分配到3个研究小组中的一个 完成基线、1个月、6个月和12个月的调查。具体目标是：1)比较 靶向干预(TP)与量身定制(TPC)干预与常规护理(UC)对CGRA的有效性 干预后6个月和移除关键通道后12个月的利用率(主要结果) 障碍；2)比较基因检测利用干预措施的有效性；3)检查潜力 潜在的理论调节和调节机制，将进一步明确和阐明重要的 干预效果；以及4)比较干预措施与常规护理的成本效益，以利用 CGRA服务。如果有效，任何一种或两种干预措施都有可能触及大量高危人群 通过广泛传播，减少家庭之间的差距。

Genetic counseling or Cancer Genetic Risk Assessment (CGRA) for hereditary breast and ovarian cancer (HBOC) is an evidence-based precision medicine strategy that facilitates informed decision making about effective health management options. Identification of individuals at increased risk of HBOC is crucial for cancer survivors and their families to benefit from biomedical advances in cancer prevention, early detection, treatment and survivorship. Although national guidelines for CGRA and genetic testing have been available for two decades, only one-third or less of high-risk women have accessed these services. The optimal risk assessment strategy starts with an individual with an HBOC-related cancer. Widespread dissemination and adoption of national guidelines for informed decision-making and promoting CGRA is needed to achieve a population-level reduction in cancer morbidity, mortality and disparities. Thus, it is important to promote access to CGRA, particularly in medically underserved populations. The proposed Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) Project seeks to address this important translational gap by developing and implementing strategies to promote guideline-based care in the Rocky Mountain region where there are distinguishable disparities in CGRA utilization by ethnicity and geography. Remarkably, few intervention studies have been conducted to address the regional and national translational gap in CGRA utilization for these diverse populations, underscoring our study's high impact and innovative public health intervention delivery approach. The GRACE Project is guided by evidenced-based behavior change counseling strategies to promote risk-based care delivery and reduce disparities that consider individual, cultural, social and system-level factors. The study's primary aim is to test the comparative effectiveness of mailed targeted print (TP) vs. TP plus a telephone-based tailored counseling and navigation intervention (TCN) vs. usual care (UC) to increase guideline-based CGRA for HBOC. We will oversample Hispanics and rural dwellers and enroll 1206 high-risk female cancer survivors. Women will be recruited through the Colorado and New Mexico cancer registries and meet the criteria for a CGRA referral. Enrollees will be randomized to one of 3 study arms and complete baseline, 1-month, 6-month and 12-month surveys. Specific aims are to: 1) compare the effectiveness of a targeted intervention (TP) vs. a tailored (TPC) intervention vs. usual care (UC) on CGRA utilization 6 months (primary outcome) after the intervention and at 12 months, after removal of key access barriers; 2) compare the effectiveness of the interventions on genetic testing utilization; 3) examine potential underlying theoretical mediating and moderating mechanisms that will further specify and elucidate significant intervention effects; and 4) compare the cost effectiveness of the interventions vs. usual care, for utilization of CGRA services. If effective, either or both interventions have the potential to reach a large number of high-risk families and reduce disparities through broad dissemination.