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--基因组测试 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博士，公共卫生硕士(联席领导)和Michael Hall，医学博士，MS(联席领导) HC：Tracey A.Revenson博士(共同领导人)和Ana F.Abraído-Lanza博士(拉丁裔文化领袖) 使用肿瘤基因组图谱(TGP)来确定潜在的癌症治疗方法也可以识别继发性癌症 患者没有意识到的遗传风险。ASCO政策要求沟通三峡工程风险并引出患者 管理这些类型的结果的首选项。Latinx患者增加了癌症风险和死亡率，但 特别容易受到障碍的影响，这些障碍会阻碍对次级遗传风险的最佳决策， 包括语言和文化适应障碍、机会和可负担性、驱逐风险、医疗不信任和低 遗传知识。这项研究的主要目标是评估电子健康(EHealth)的效果 决策支持工具(DST)，以增加拉美裔患者的知情决策。这项建议的基础是 在黑人癌症患者中测试名为gene Pilot的eHealth DST的当前RCT结果和形成工作 由目前的U54伙伴关系的试点机制资助的Latinx患者。这些研究使用了创新的 商业营销方法，以解决三峡工程问题，促进知情决策，并增加 与供应商就二次遗传信息的偏好进行沟通。停在渥太华 框架，这项研究将确定与传统决定相比，修订后的DST基因PilotLX的有效性 支持。具体目标是：1.修订基因引导DST，以反映与Latinx癌症患者的形成工作，以 融入特定的文化价值观和语言需求。我们将利用形成的成果，建立社区 和科学咨询委员会修改内容，使其与文化联系在一起。然后，我们将进行用户测试 对25名Latinx癌症患者进行研究；2.在随机试验中测试基因PilotLX的影响。我们将进行全面的 为四个肿瘤学站点的232名Latinx癌症患者提供RCT支持。干预参与者将能够访问 Gene PilotLX通过平板电脑或个人设备；对比组将接受无针对性的教育材料 关于三峡工程。主要结果包括决策准备、决策冲突和沟通 医生的喜好。次要结果包括与家人沟通偏好和改变 对三峡工程的看法。H1：那些在基因飞行员LX手臂中的人将有更大的减少决策冲突和更高的 决策准备与非目标决策援助的比较。H2：基因PilotLX手臂中的人将报告 与非靶向信息组相比，更多地将TGP偏好传达给他们的肿瘤医生； 以及3.确定PilotLX基因对初级和次级结果的影响是否受到 拉丁裔文化价值观与文化适应。H3：PilotLX基因将对这些患者的主要结局产生更大影响 具有较强的家族主义价值观，比价值观较低的人文化适应程度高。这个 FATALLISMO的Latinx值将发生反转。打破制度性障碍：与U54的S接轨 包容性卓越愿景，这项研究通过关注Latinx特有的挑战来解决系统性障碍 参与和沟通TGP，从而通过改善改善减少潜在的癌症健康差距 在癌症高危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.