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.

项目概要 完整研究项目 1 – 基因组测试 测试电子医疗决策支持工具帮助拉丁裔癌症患者了解情况的功效 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（联合领导者）和 Michael Hall，医学博士、硕士（联合领导者） HC：Tracey A. Revenson 博士（联合领导者）和 Ana F. Abraído-Lanza 博士（拉丁文化领导者） 使用肿瘤基因组分析 (TGP) 来识别潜在的癌症治疗方法还可以识别继发性癌症 患者不知道的遗传风险 ASCO 政策要求沟通 TGP 风险并引起患者注意。 管理这些类型结果的偏好增加了癌症风险和死亡率，但 尤其是那些会阻碍有关次生遗传风险的最佳决策的脆弱障碍， 包括语言和文化障碍、获取和负担能力、驱逐出境风险、医疗不信任和低 本研究的主要目标是评估电子健康（eHealth）的功效。 决策支持工具（DST）可提高拉丁裔患者的知情决策能力。 当前对黑人癌症患者进行名为“基因试点”的电子健康 DST 测试的随机对照试验结果和形成性工作 由当前 U54 合作伙伴试点机制资助的拉丁裔患者这些研究采用创新技术。 商业营销方法来解决 TGP 问题、促进明智的决策并提高 与提供者就二次遗传信息的偏好进行沟通 扎根于渥太华。 框架，该研究将确定修订后的 DST、Gene PilotLX 与传统决策相比的功效 具体目标是： 1. 修订基因试点 DST 以反映针对拉丁裔癌症患者的形成性工作 我们将利用形成性结果并建立社区，以纳入特定的文化价值观和语言需求。 和科学顾问委员会修改内容，使其符合文化要求，然后我们将进行用户测试。 2. 在一项完全随机的试验中测试 Gene PilotLX 的影响。 在四个肿瘤中心对 232 名拉丁裔癌症患者进行了随机对照试验，干预参与者将有机会获得这些信息。 Gene PilotLX 通过平板电脑或个人设备；比较组将收到非针对性的教育材料 关于 TGP 的主要成果包括决策准备、决策冲突和沟通。 次要结果包括与家人的偏好沟通以及个人偏好的变化。 H1 的看法：Gene PilotLX 部门的决策冲突会更大程度地减少，并且会更高。 与非目标决策辅助相比的决策准备情况 H2：Gene PilotLX 部门的人员将报告。 与非针对性信息部门相比，更多地与肿瘤科医生沟通 TGP 偏好； 3. 确定 Gene PilotLX 对主要和次要结果的影响是否受到以下因素的调节 H3：基因 PilotLX 将对这些人的主要结果产生更大的影响。 持有较强家庭主义价值观的人比那些价值观较低的人更受文化熏陶。 与U54的拉丁价值观的宿命论相反，打破系统性的包容性障碍。 包容性卓越的愿景，本研究通过关注拉丁裔特定的挑战来解决系统性障碍 参与和交流 TGP，从而通过改善潜在的癌症健康差异 在未充分研究的癌症高风险人群中做出明智的决策。