Department of Epidemiology, School of Public Health, Rutgers University, New Brunswick, Jersey; Cancer Institute of New Jersey, Rutgers University, New Brunswick, Jersey.
Comprehensive Cancer Center, University of New Mexico, Albuquerque, Mexico.
Contemp Clin Trials. 2018 Oct;73:123-135. doi: 10.1016/j.cct.2018.09.005. Epub 2018 Sep 18.
Although national guidelines for cancer genetic risk assessment (CGRA) for hereditary breast and ovarian cancer (HBOC) have been available for over two decades, less than half of high-risk women have accessed these services, especially underserved minority and rural populations. Identification of high-risk individuals is crucial for cancer survivors and their families to benefit from biomedical advances in cancer prevention, early detection, and treatment.
This paper describes community-engaged formative research and the protocol of the ongoing randomized 3-arm controlled Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) trial. Ethnically and geographically diverse breast and ovarian cancer survivors at increased risk for hereditary cancer predisposition who have not had a CGRA are recruited through the three statewide cancer registries. The specific aims are to: 1) compare the effectiveness of a targeted intervention (TP) vs. a tailored counseling and navigation(TCN) intervention vs. usual care (UC) on CGRA utilization at 6 months post-diagnosis (primary outcome); compare the effectiveness of the interventions on genetic counseling uptake at 12 months after removal of cost barriers (secondary outcome); 2) examine potential underlying theoretical mediating and moderating mechanisms; and 3) conduct a cost evaluation to guide dissemination strategies.
The ongoing GRACE trial addresses an important translational gap by developing and implementing evidence-based strategies to promote guideline-based care and reduce disparities in CGRA utilization among ethnically and geographically diverse women. If effective, these interventions have the potential to reach a large number of high-risk families and reduce disparities through broad dissemination.
NCT03326713; clinicaltrials.gov.
尽管癌症遗传风险评估（CGRA）的国家指南已经存在了二十多年，但只有不到一半的高风险女性接受了这些服务，尤其是服务不足的少数族裔和农村地区的女性。确定高风险个体对于癌症幸存者及其家庭从癌症预防、早期发现和治疗的生物医学进展中获益至关重要。
本文描述了社区参与的形成性研究和正在进行的随机 3 臂对照遗传风险评估以进行癌症教育和赋权（GRACE）试验的方案。通过三个全州癌症登记处招募了患有遗传性癌症易感性增加的乳腺癌和卵巢癌幸存者，这些幸存者尚未进行 CGRA。具体目标是：1）比较靶向干预（TP）与量身定制的咨询和导航（TCN）干预与常规护理（UC）在诊断后 6 个月 CGRA 利用率方面的有效性（主要结局）；比较干预措施在消除成本障碍后 12 个月内对遗传咨询参与的有效性（次要结局）；2）检查潜在的潜在理论中介和调节机制；并 3）进行成本评估以指导传播策略。
正在进行的 GRACE 试验通过制定和实施循证策略来解决重要的转化差距，以促进基于指南的护理并减少不同种族和地理背景的女性在 CGRA 利用方面的差异。如果有效，这些干预措施有可能通过广泛传播来接触到大量高危家庭并减少差异。
NCT03326713；clinicaltrials.gov。
