Full Research Project 1: Testing the Efficacy of an eHealth Decision Support Tool to Help Latinx Cancer Patients Make Informed Decisions About Tumor Genomic Testing

项目摘要 完整研究项目1 -基因组检测 测试电子健康决策支持工具的有效性，以帮助Latinx癌症患者了解 关于肿瘤基因组检测的决定 TU FCCC：Sarah Bauerle Bass，PhD，MPH（联合负责人）和Michael Hall，MD，MS（联合负责人） HC：Tracey A. Revenson博士（共同负责人）和Ana F. Abraído-Lanza，博士（拉丁文化领袖） 使用肿瘤基因组分析（TGP）来确定潜在的癌症治疗方法也可以确定继发性肿瘤。 患者没有意识到的遗传风险。ASCO政策要求TGP风险的沟通， 管理这些类型的结果的偏好。拉丁裔患者的癌症风险和死亡率增加，但 特别容易受到阻碍对次级遗传风险做出最佳决策的障碍的影响， 包括语言和文化适应障碍、获取和负担能力、驱逐风险、医疗不信任和低 基因知识本研究的主要目的是评估电子健康（eHealth）的有效性。 决策支持工具（DST），以增加拉丁美洲患者的知情决策。该提案基于 对黑人癌症患者和形成性工作进行电子健康DST（称为Gene Pilot）测试的当前RCT结果 与拉丁病人资助的试点机制，目前的U 54伙伴关系。这些研究采用了创新的 商业营销方法，以解决三峡工程的关注，促进明智的决策，并增加 与提供者沟通对二级遗传信息的偏好。停在渥太华 框架，该研究将确定修订的DST，基因PilotLX，与传统的决定相比， 支持.具体目标是：1。修订基因试点DST，以反映拉丁癌症患者的形成性工作， 结合具体的文化价值观和语言需要。我们将使用形成性结果并建立社区 和科学咨询委员会修改内容，使其具有文化锚定。然后我们将进行用户测试 25例拉丁癌症患者; 2.在随机试验中测试Gene PilotLX的影响。我们将进行全面的 在4个肿瘤研究中心纳入232例Latinx癌症患者的有效RCT。干预参与者将获得 Gene PilotLX通过平板电脑或个人设备;对照组将收到非目标教育材料 关于TGP主要成果包括决策准备、决策冲突和 医生的偏好。次要结果包括与家人的偏好沟通以及 对TGP的看法H1：Gene PilotLX组的决策冲突减少程度更高， 与非目标决策辅助相比，决策准备。H2：Gene PilotLX组将报告 与非目标信息臂相比，与肿瘤学家更多地交流TGP偏好; 和3.确定Gene PilotLX对主要和次要结局的影响是否受到以下因素的调节： 拉丁文化价值观和文化适应。H3：Gene PilotLX将对那些 家庭主义价值观较强，文化适应程度较低。的 相反的情况会发生在拉丁的宿命论价值上。打破包容性的系统性障碍：符合U 54的 包容性卓越愿景，这项研究通过关注拉丁美洲特有的挑战来解决系统性障碍， 参与和宣传TGP，从而通过改善 在未充分研究的癌症高风险人群中做出明智的决策。

Project Summary Full Research Project 1 – Genomic Testing Testing the Efficacy of an eHealth Decision Support Tool to Help Latinx Cancer Patients Make Informed Decisions About Tumor Genomic Testing TU FCCC: Sarah Bauerle Bass, PhD, MPH (Co-Leader) and Michael Hall, MD, MS (Co-Leader) HC: Tracey A. Revenson, PhD (Co-Leader) and Ana F. Abraído-Lanza, PhD (Latinx Culture Leader) The use of tumor genomic profiling (TGP) to identify potential cancer treatments can also identify secondary hereditary risks the patient was unaware of. ASCO policy mandates communication of TGP risks and elicit patient preferences for managing these types of results. Latinx patients have increased cancer risk and mortality but are especially vulnerable to barriers that would impede optimal decision making about secondary genetic risks, including language and acculturation barriers, access and affordability, deportation risks, medical mistrust and low genetic knowledge. The primary goal of this study is to evaluate the efficacy of an electronic health (eHealth) decision support tool (DST) to increase informed decision making among Latinx patients. This proposal builds on current RCT results of testing an eHealth DST called Gene Pilot with Black cancer patients and formative work with Latinx patients funded by the pilot mechanism of the current U54 Partnership. These studies use innovative commercial marketing methods to address TGP concerns, promote informed decision making, and increase communication with providers about preferences for secondary genetic information. Grounded in the Ottawa Framework, the study will determine the efficacy of a revised DST, Gene PilotLX, compared to traditional decision support. Specific aims are: 1. Revise the Gene Pilot DST to reflect formative work with Latinx cancer patients to incorporate specific cultural values and language needs. We will use formative results and establish Community and Scientific Advisory Boards to revise content to make it culturally-anchored. We will then conduct user testing with 25 Latinx cancer patients; 2. Test the impact of Gene PilotLX in a randomized trial. We will conduct a fully powered RCT with 232 Latinx cancer patients at four oncology sites. Intervention participants will have access to Gene PilotLX via a tablet or personal device; the comparison arm will receive non-targeted education materials about TGP. Primary outcomes include decision preparedness, decisional conflict, and communication of preferences with a doctor. Secondary outcomes include communication of preferences with family and changes in perceptions of TGP. H1: Those in the Gene PilotLX arm will have greater reduced decisional conflict and higher decision preparedness compared to the non-targeted decision aid. H2: Those in the Gene PilotLX arm will report communicating TGP preferences with their oncologist more when compared to the non-targeted information arm; and 3. Determine whether the effects of Gene PilotLX on primary and secondary outcomes are moderated by Latinx cultural values and acculturation. H3: Gene PilotLX will have a larger effect on primary outcomes for those holding stronger values of familismo and those who are more acculturated than those with lower values. The reverse will occur with the Latinx value of fatalismo. Break Systemic Barriers to Inclusion: In line with the U54’s Inclusive Excellence vision, this study addresses systemic barriers by focusing on Latinx-specific challenges to engaging and communicating about TGP, thereby reducing potential cancer health disparities by improving informed decision making in an under-studied population at high risk of cancer.