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)风险增加的女性 由于BRCA1/2突变，请转介进行遗传咨询，并考虑进行基因检测。意识到 阳性结果可以为癌症患者的治疗决定和两种癌症的风险管理计划提供信息 幸存者和未受癌症影响的妇女。将准则转化为实践的速度缓慢尤其影响 在社区卫生诊所接受服务的少数民族人口。拉美裔女性的知晓率较低 和使用遗传咨询和检测(GCT)比非拉丁裔白人。拉丁裔面临多重医疗保健， 影响GCT普及的实用和心理社会障碍。拉丁裔更喜欢西班牙语中有文化针对性的干预 用通俗易懂的语言、视觉辅助手段和叙事格式。我们开发了一段具有文化针对性的叙事视频 西班牙语是高危拉丁人的意思。在单臂试验(N=40)中进行试点的拉丁裔患者报告说非常满意并展示了 从考试前到考试后，知识有了显著的增长。几乎所有参与者(95%)都表示对 GCT，62%的人完成了遗传咨询。我们将使用一种创新的混合研究设计，将 传统功效研究的要素以及实施研究的最佳做法，以加强 翻译过程的质量和速度。在扩展的集成行为模型的指导下，我们将 进行随机对照试验，以评估我们的视频与FORCE情况说明书在增强GCT摄入量和 心理社会后果。为了最大限度地发挥社区诊所的实施潜力，我们将培训诊所 工作人员管理转诊筛查工具(RST)，这是一种有效的工具，用于识别处于HBOC风险中的妇女。引导式 根据实施研究综合框架，我们将开展以实施为重点的 流程评估，以收集关于临床实施结果的数据，以使用转诊筛查工具和 录像带。我们将向参与者推荐免费的西班牙电话遗传咨询。我们将随机抽查300名有风险的 在拉丁裔人口众多的四个地点。我们的主要成果是遗传咨询的接受。 目标1.评估我们的视频与情况说明书对GCT应用的影响。视频手臂的参与者将拥有 较高的遗传咨询接受度(H1.1)和较高的遗传检测摄取率(H1.2)。在4个月的时候。 目标2.评估我们的视频与情况说明书对心理社会和流程评估结果的影响。H2.1： 视频参与者将拥有更高的知识、积极的态度、主观规范、自我效能感和积极 预期性情绪。H2.2。视频参与者将具有更高的可接受性和可行性评级。 研究目标：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ARM对咨询的理解没有不同，那么我们将评估 吸食的预测指标。 目标3.检查可行性、可接受性、采用率、忠诚度和未来的关键实施成果 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.