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

完整研究项目 1：测试电子健康决策支持工具的功效，以帮助拉丁裔癌症患者就肿瘤基因组测试做出明智的决定

• 批准号: 10757259
• 负责人: Sarah B Bass
• 金额: $ 6.67万
• 依托单位: TEMPLE UNIV OF THE COMMONWEALTH
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-19 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10757259
• 关键词: 3-Dimensional; Acculturation; Address; Affect; African American; American Society of Clinical Oncology; Bass; Biostatistics Core; Black race; Cancer Center; Cancer Patient; Cervical; Communication; Communities; Community Outreach; Comparison arm; Conflict (Psychology); Country; Data; Decision Aid; Decision Making; Devices; Dimensions; Doctor of Philosophy; Educational Materials; Effectiveness; Family; Funding; Gallbladder; Gender; Genes; Genetic; Genetic Counseling; Genetic Risk; Genetic study; Genomics; Goals; Grant; Health; Health Promotion; Health behavior change; High-Risk Cancer; Hispanic Americans; Information Management; Intervention; Knowledge; Language; Latinx; Latinx population; Link; Liver; Malignant Neoplasms; Malignant neoplasm of urinary bladder; Maps; Marketing; Medical; Medical Genetics; Methods; Modeling; Mutation; New York City; Not Hispanic or Latino; Oncologist; Oncology; Patient Preferences; Patient Recruitments; Patients; Perception; Philadelphia; Policies; Population; Population Heterogeneity; Provider; Public Health; Readiness; Reporting; Research Personnel; Research Project Grants; Risk; Risk Assessment; Site; Stomach; Tablets; Test Result; Testing; Underserved Population; Vision; Work; Writing; arm; cancer health disparity; cancer risk; cancer therapy; cultural values; eHealth; education research; efficacy evaluation; efficacy testing; ethnic diversity; falls; genetic information; genetic testing; health equity; hereditary risk; improved; innovation; intervention participants; mortality; precision oncology; preference; primary outcome; provider communication; racial diversity; randomized trial; recruit; secondary outcome; support tools; systemic barrier; tool; treatment arm; tumor; vector

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.

项目摘要 完整的研究项目1 - 基因组测试 测试eHealth决策支持工具的功效，以帮助拉丁癌患者进行知情 关于肿瘤基因组测试的决定 TU FCCC：Sarah Bauerle Bass，博士，MPH（共同领导）和Michail Hall，MD，MS（共同领导者） HC：Tracey A. Revenson博士（共同领导）和Ana F.Abraído-Lanza，PhD（拉丁文文化领导者） 使用肿瘤基因组分析（TGP）来鉴定潜在的癌症治疗 遗传风险不知道。 ASCO政策要求TGP风险的通信并引起患者 管理这些类型结果的偏好。拉丁人患者的癌症风险和死亡率增加，但 特别容易受到障碍的攻击，这些障碍会阻碍有关次要遗传风险的最佳决策， 包括语言和培养障碍，访问和可用性，驱逐出境风险，医疗不信任和低 遗传知识。这项研究的主要目的是评估电子健康的效率（EHealth） 决策支持工具（DST）增加了拉丁患者中明智的决策。该提议建立在 当前的RCT测试eHealth DST的RCT结果称为Gene Pilot，黑色癌症患者和形成性工作 拉丁患者由当前U54合作伙伴的试验机制资助。这些研究使用创新 商业营销方法来解决TGP问题，促进明智的决策并增加 与提供者沟通有关二级遗传信息的偏好。扎根于渥太华 框架，该研究将确定经过修订的DST Gene Pilotlx的效率与传统决定相比 支持。具体目的是：1。修改基因飞行员DST，以反映拉丁癌患者的形成性工作 结合特定的文化价值和语言需求。我们将使用形成性的结果并建立社区 和科学咨询委员会修改内容以使其具有文化锚定。然后，我们将进行用户测试 有25例拉丁癌患者； 2。在随机试验中测试基因pilotlx的影响。我们将充分进行 在四个肿瘤学位的232例拉丁癌患者中为RCT提供动力。干预参与者将可以访问 通过平板电脑或个人设备的Gene Pilotlx；比较部门将获得非目标的教育材料 关于TGP。主要结果包括决策准备，决策冲突和交流 与医生的偏好。次要结果包括与家庭的偏好交流和变化 TGP的感知。 H1：基因驾驶臂中的那些人将有更大的决策冲突和更高的冲突 与非目标的决策援助相比，决策准备。 H2：基因驾驶臂中的那些将报告 与非目标信息部门相比，与其肿瘤学家交流TGP偏好更多； 和3。确定基因pripotlx对原发性和次要结果的影响是否受到调节 拉丁文文化价值和培养。 H3：Gene Pilotlx将对那些的主要结果产生更大的影响 拥有强大的家庭主义价值观和比价值较低的人更具培养的人。这 致命症的拉丁文值将发生反向。打破全身性障碍：与U54一致 包容性卓越的愿景，本研究通过关注拉丁裔特定挑战来解决系统障碍 参与和交流TGP，从而通过改进来减少潜在的癌症健康分布 癌症高风险的人口不足的人群中有明智的决策。