Promoting guideline-based cancer genetic risk assessment for hereditary breast and ovarian cancer in ethnically and geographically diverse cancer survivors: Rationale and design of a 3-arm randomized controlled trial.

Promoting guideline-based cancer genetic risk assessment for hereditary breast and ovarian cancer in ethnically and geographically diverse cancer survivors: Rationale and design of a 3-arm randomized controlled trial.
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DOI:
10.1016/j.cct.2018.09.005
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发表时间:
2018-10
影响因子:
2.2
通讯作者:
Walters ST
Walters ST
中科院分区:
医学4区
文献类型:
--
作者:
Kinney AY;Howell R;Ruckman R;McDougall JA;Boyce TW;Vicuña B;Lee JH;Guest DD;Rycroft R;Valverde PA;Gallegos KM;Meisner A;Wiggins CL;Stroup A;Paddock LE;Walters ST

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尽管针对遗传性乳腺癌和卵巢癌(HBOC)的癌症遗传风险评估(CGRA)国家指南已问世二十多年,但不到一半的高风险女性使用过这些服务,尤其是服务不足的少数族裔和农村人口。识别高风险个体对于癌症幸存者及其家庭从癌症预防、早期检测和治疗的生物医学进展中获益至关重要。 本文介绍了社区参与的形成性研究,以及正在进行的三臂随机对照“癌症遗传风险评估教育与赋能”(GRACE)试验的方案。通过三个全州范围的癌症登记处,招募具有遗传性癌症易感性较高风险、但尚未接受过CGRA的不同种族和地域的乳腺癌和卵巢癌幸存者。具体目标为:1)比较靶向干预(TP)、定制咨询与导航(TCN)干预以及常规护理(UC)在诊断后6个月对CGRA使用率的效果(主要结局);比较去除费用障碍12个月后,这些干预措施对遗传咨询接受度的效果(次要结局);2)研究潜在的理论中介和调节机制;3)开展成本评估以指导推广策略。 正在进行的GRACE试验通过制定和实施基于证据的策略,来促进基于指南的医疗服务,并减少不同种族和地域女性在CGRA使用方面的差异,从而填补了一个重要的转化空白。如果这些干预措施有效,就有可能惠及大量高风险家庭,并通过广泛推广来减少差异。
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.
黑人妇女知道并想了解BRCA1/2的咨询和测试。
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