Testing a culturally targeted narrative video to reduce disparities in the use of genetic counseling and testing in Latina women at-risk of HBOC

摘要 国家指南建议，遗传性乳腺癌和卵巢癌（HBOC）风险增加的妇女 由于BRCA 1/2突变被转介遗传咨询，并考虑基因检测。知名度 积极的结果可以为癌症患者的治疗决策和癌症风险管理计划提供信息。 幸存者和未受癌症影响的女性。指导方针转化为实践的缓慢特别影响到 在社区卫生诊所接受服务的少数民族人口。拉丁裔女性的意识较低 和使用遗传咨询和测试（GCT）比非拉丁裔白人。拉丁裔面临多重医疗保健， 实用主义和心理障碍的GCT吸收。拉丁裔更喜欢用西班牙语进行有文化针对性的干预 用简单的语言，视觉辅助，和叙述的形式。我们开发了一个有文化针对性的叙事视频， 西班牙语是给有危险的拉丁裔的在一项单臂试验（N=40）中，拉丁裔报告了高满意度， 从测试前到测试后，知识有了显著的增长。几乎所有参与者（95%）都表示对以下方面感兴趣： GCT，62%完成遗传咨询。我们将采用创新的混合研究设计， 传统功效研究的要素以及实施研究的最佳做法， 翻译过程的质量和速度。在扩展的综合行为模型的指导下，我们将 进行随机对照试验，以评估我们的视频与FORCE事实说明书在增强GCT摄取方面的有效性， 心理社会结果。为了最大限度地发挥在社区诊所实施的潜力，我们将培训诊所 工作人员管理转诊筛查工具，这是一个经验证的工具，用于识别有高血压风险的妇女。指导 根据实施研究的综合框架，我们将开展一项以实施为重点的 流程评估，收集诊所实施结果数据，以使用转诊筛选工具， 视频.我们将为参与者提供免费的西班牙语电话遗传咨询。我们将随机抽取300名高危人群 拉丁裔在四个网站与大拉丁裔人口。我们的主要成果是遗传咨询的吸收。 目标1.评估我们的视频与事实说明书对GCT吸收的影响。视频组的参与者将拥有 更高的遗传咨询接受率（H1.1.）和更高的基因检测吸收率（H1.2.）4个月时。 目标2.评估我们的视频与情况说明书对社会心理和过程评估结果的影响。H2.1： 视频参与者会有更高的知识、积极态度、主观规范、自我效能感、积极 预期的情绪。H2.2。视频参与者将有更高的可接受性和可行性评级。 探索性目的：评估视频对遗传咨询吸收的影响机制（知识，态度， 规范、自我效能、预期情绪）。如果咨询吸收不存在手臂差异，那么我们将评估 摄取的预测因子。 目标3.审查可行性、可接受性、采用性、忠实性和未来的关键实施结果 在社区诊所使用转诊筛查工具和视频的可持续性。

ABSTRACT National guidelines recommend that women at increased risk for Hereditary Breast and Ovarian Cancer (HBOC) due to BRCA1/2 mutations be referred for genetic counseling and consider genetic testing. Awareness of a positive result can inform treatment decisions for cancer patients and risk management plans in both cancer survivors and women unaffected with cancer. The slow translation of guidelines into practice particularly impacts minority populations who receive services in community health clinics. Latina women have lower awareness and use of genetic counseling and testing (GCT) than non-Latina Whites. Latinas face multiple health care, pragmatic, and psychosocial barriers to GCT uptake. Latinas prefer culturally targeted interventions in Spanish with plain language, visual aids, and a narrative format. We developed a culturally targeted narrative video in Spanish for at-risk Latinas. Piloted in a single-arm trial (N=40), Latinas reported high satisfaction and exhibited a significant increase in knowledge from pre- to post-test. Nearly all participants (95%) reported an interest in GCT, and 62% completed genetic counseling. We will use an innovative hybrid research design that combines elements of traditional efficacy studies as well as best practices from implementation research to enhance the quality and speed of the translational process. Guided by an expanded Integrated Behavioral Model, we will conduct a RCT to evaluate the efficacy of our video vs. the FORCE fact sheet on enhancing GCT uptake and psychosocial outcomes. To maximize the potential for implementation in community clinics, we will train clinic staff to administer the Referral Screening Tool (RST), a validated tool to identify women at-risk of HBOC. Guided by the Consolidated Framework for Implementation Research, we will conduct an Implementation Focused Process Evaluation to gather data on clinic implementation outcomes for use of the Referral Screening Tool and the video. We will refer participants to free Spanish telephone genetic counseling. We will randomize 300 at-risk Latinas at four sites with large Latinx populations. Our primary outcome is genetic counseling uptake. Aim 1. Evaluate the impact of our video vs. fact sheet on GCT uptake. Participants in the video arm will have higher genetic counseling uptake (H1.1.) and higher genetic testing uptake (H1.2.) at 4 months. Aim 2. Evaluate the impact of our video vs. fact sheet on psychosocial and process evaluation outcomes. H2.1: Video participants will have higher knowledge, positive attitudes, subjective norms, self-efficacy, and positive anticipatory emotions. H2.2. Video participants will have higher acceptability and feasibility ratings. Exploratory aim: Evaluate mechanisms of the video's impact on genetic counseling uptake (knowledge, attitudes, norms, self-efficacy, anticipatory emotions). If counseling uptake does not differ by arm, then we will evaluate predictors of uptake. Aim 3. Examine key implementation outcomes of feasibility, acceptability, adoption, fidelity, and future sustainability of using the Referral Screening Tool and the video at the community clinics.