Prospective Trial of a Linguistically and Culturally Appropriate Mainstreaming Model for Hereditary Cancer Multigene Panel Testing Among Diverse Cancer Patients

在不同癌症患者中进行遗传性癌症多基因面板测试的语言和文化上适当的主流模型的前瞻性试验

• 批准号: 10264876
• 负责人: Jada Gabrielle Hamilton
• 金额: $ 73.32万
• 依托单位: SLOAN-KETTERING INST CAN RESEARCH
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-16 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10264876
• 关键词: Address; Adopted; Behavior; Cancer Center; Cancer Patient; Characteristics; Clinic; Clinic Visits; Clinical; Communication; Community Hospitals; Comprehension; Consultations; County Hospitals; Decision Making; Diagnosis; Disclosure; Distress; Education; Educational Materials; Ethnic Origin; Evaluation; Family; Future; Genetic; Genetic Counseling; Genetic Risk; Genomic medicine; Haitian; Health Personnel; Hereditary Malignant Neoplasm; Hereditary Neoplastic Syndromes; Intervention; Knowledge; Language; Latino; Learning; Linguistics; Mainstreaming; Malignant Neoplasms; Malignant neoplasm of ovary; Malignant neoplasm of pancreas; Malignant neoplasm of prostate; Medical; Medical Oncology; Memorial Sloan-Kettering Cancer Center; Methods; Minority; Modeling; Oncologist; Outcome; Pamphlets; Pathogenicity; Patients; Population Heterogeneity; Pre-Post Tests; Predisposition; Race; Randomized; Randomized Clinical Trials; Research; Research Design; Research Methodology; Risk; Risk Assessment; Risk Management; Site; Telephone; Test Result; Testing; Time; Update; Variant; Videoconferencing; base; behavioral outcome; behavioral response; brca gene; cancer risk; cancer therapy; cognitive interview; empowerment; ethnic diversity; experimental study; genetic counselor; genetic panel test; genetic testing; genetic variant; health literacy; hereditary risk; high school; improved; literacy; malignant breast neoplasm; medically underserved; non-genetic; patient population; primary outcome; prospective; psychosocial; racial and ethnic; response; satisfaction; sex; standard of care; testing uptake; treatment choice; uptake; variant of unknown significance

PROJECT SUMMARY Efficient yet effective models for delivering genetic counseling and testing are sorely needed to meet increasing demands for timely genetic risk information. Traditional germline genetic testing models, which include in-depth genetic counseling both before and after testing, are time intensive and place substantial demands on the limited genetic counselor workforce. A “mainstreaming” model, which allows for non-genetics healthcare providers to order genetic testing without pre-test genetic counseling, with support from genetic counselors at the time of result disclosure, has shown promise. Yet, past evaluations of mainstreaming models have been hampered by serious limitations: Studies were restricted to the context of BRCA1/2 testing and do not reflect the growing use of multigene panel testing (MGPT); rarely used rigorous experimental study designs or evaluated theoretically-relevant decision-making, psychosocial, and communication outcomes; have not capitalized on opportunities to improve post-test clinical and familial communication; and neither included nor addressed informational needs of minority and medically underserved patients. We overcome these limitations with the proposed study, the objective of which is to develop, test, and evaluate a linguistically and culturally appropriate mainstreaming (LCAM) model for hereditary cancer MGPT among cancer patients diverse in race/ethnicity, language, and education. We will first use formative research methods, including transcreation and cognitive interviewing, to adapt existing pre-test educational materials and post-test clinical communication materials for use among the diverse population treated at our community hospital partnering sites (Kings County Hospital Center, Queens Cancer Center). Next, we will conduct an RCT involving English, Haitian Creole, or Spanish-speaking patients diagnosed with breast, ovarian, pancreatic, or prostate cancer (N=500). Patients will be randomized to obtain access to cancer MGPT through either: i) standard-of-care wherein in- depth pre-test and post-test genetic counseling are provided via telegenetics (i.e., videoconferencing delivered at the site clinic) with standard post-test clinical communication materials, or ii) LCAM intervention wherein patients receive the adapted pre-test educational materials with testing ordered by their oncologist, followed by post-test genetic counseling provided via telephone with adapted clinical communication materials. Patients will complete assessments of decision-making, psychosocial, and behavioral outcomes at baseline, upon deciding whether to have MGPT, and at 1-week and 6-months following receipt of their test results. Long-term engagement among patients who receive a variant of uncertain significance (VUS) result will also be explored one year after result receipt through uptake of an offer to discuss any changes in cancer risk or variant reclassification and an additional assessment. This research has the potential to transform genetic counseling and testing practice by promoting effective risk communication, decision making, and more equitable delivery of genomic medicine to those at risk of hereditary cancer syndromes.

项目摘要 迫切需要有效但有效的遗传咨询和测试模型来满足 对及时的遗传风险信息的需求增加。传统种系基因检测模型， 在测试之前和测试后都包括深入的遗传咨询 对有限的遗传顾问劳动力的需求。 “主流”模型，该模型允许非基因学 遗传的支持 在结果披露时的计数已显示出希望。然而，过去对主流模型的评估 严重局限性受到阻碍：研究仅限于BRCA1/2测试的背景 不反映多基因面板测试（MGPT）的日益增长的使用；很少使用严格的实验研究设计 或评估与神秘的决策，社会心理和沟通成果；没有 利用改善测试后临床和家庭交流的机会；既不包括也不包括 解决了少数民族和医疗服务不足的患者的信息。我们克服了这些限制 通过拟议的研究，其目的是在语言和文化上发展，测试和评估 癌症患者的遗传性癌症MGPT的适当主流模型（LCAM）模型 种族/种族，语言和教育。我们将首先使用形成性研究方法，包括转录 和认知访谈，以适应现有的测试前教育材料和测试后临床交流 在我们社区医院合作网站治疗的潜水员人口中使用的材料（国王 皇后癌中心县医院中心）。接下来，我们将进行涉及英语，海地的RCT 克里奥尔语或讲西班牙语的患者被诊断出患有乳房，卵巢，胰腺或前列腺癌（n = 500）。 患者将被随机分配，以通过以下任务获得癌症MGPT：i）现行标准 深度测试和测试后的遗传咨询是通过Telegenetics提供的（即交付的视频会议 在现场诊所）具有标准测试后临床通信材料，或II）LCAM干预措施 患者通过其肿瘤科医生订购的测试接受了改编的预测试教育材料，其次是 测试后的遗传咨询通过电话提供，并提供适应性的临床通信材料。患者 将在基线时完成对决策，社会心理和行为结果的评估 确定是否有MGPT，在收到测试结果后1周和6个月。长期 还将探索获得不确定意义的变体（VUS）的患者之间的参与度（VUS） 结果收据后一年通过提出的报价讨论癌症风险或变体的任何变化 重新分类和附加评估。这项研究有可能改变遗传咨询 通过促进有效的风险交流，决策和更公平的交付来测试实践 对有遗传性癌症综合症风险的人的基因组医学。