Addressing Genomic Disparities in Cancer Survivors

解决癌症幸存者的基因组差异

• 批准号: 10813426
• 负责人: Anita Y. Kinney
• 金额: $ 67.95万
• 依托单位: RUTGERS BIOMEDICAL AND HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-03-09 至 2028-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10813426
• 关键词: 2 arm randomized control trial; Address; Advanced Malignant Neoplasm; Advocate; Arousal; Awareness; Black Populations; Black race; Cancer Patient; Cancer Survivor; Cancer health equity; Caring; Chronic; Clinical; Clinical Oncology; Communication; Communities; Complex; Conflict (Psychology); Counseling; Data; Decision Making; Development; Diagnosis; Disease; Disparity; Distress; Education; Effectiveness; Enrollment; Equity; Ethnic Population; Family; Family member; Fright; Genetic; Genetic Counseling; Genome; Genomics; Goals; Guidelines; Happiness; Health Insurance Portability and Accountability Act; Health Services; Health behavior; Healthcare Systems; Hereditary Malignant Neoplasm; Hereditary Neoplastic Syndromes; High-Risk Cancer; Improve Access; Individual; Inequity; Knowledge; Laboratories; Letters; Life; Malignant Neoplasms; Mediating; Mediator; Medical; Methodology; Modeling; Motivation; Not Hispanic or Latino; Oncology; Outcome; Participant; Pathogenicity; Patients; Perception; Physicians; Policies; Population; Prevention; Primary Prevention; Provider; Public Health; Randomized; Regrets; Resources; Risk; Second Primary Cancers; Secondary Cancer Prevention; Secondary Prevention; Service delivery model; Services; Survivors; System; Testing; Time; Underserved Population; Variant; Work; access disparities; arm; black patient; cancer genomics; cancer health disparity; cancer therapy; care delivery; chatbot; clinical practice; community engagement; comparative efficacy; cost; digital intervention; disparity reduction; empowerment; experience; genetic counselor; genetic testing; health care delivery; high risk; implicit bias; individualized prevention; innovation; low socioeconomic status; meetings; mortality; optimism; personalized cancer therapy; personalized care; psychosocial; racial disparity; racial minority; racial population; response; satisfaction; screening; social culture; testing uptake; therapy resistant; treatment as usual; underserved minority; usual care arm

Genetic testing (GT) for hereditary cancer and related health services do not reach all segments of the population equitably. Racial disparities in genomic care are profound, persistent, and growing. Less than 30% of high-risk cancer patients are referred for germline GT, with appreciably lower referral and testing rates among racial minorities, especially among Blacks. GT of cancer survivors can directly inform treatment following progression or treatment resistance and can facilitate primary and secondary prevention of cancers in their unaffected relatives. Demand for GC (genetic counseling) and GT continues to increase with expanding GT indications and decreasing sequencing costs yet supply of genetic counselors remains limited. The conventional approach of referral to pretest genetic counseling is a common barrier to receiving GT. Further, evidence suggests that traditional comprehensive, pre-test GC does not meet the needs of many survivors, especially underserved minorities. Thus, new models of genome-based care are needed that are responsive to community needs, improve access, do not overburden scarce genetic counseling resources, and do not widen existing disparities. Some health care systems and commercial GT laboratories use digital interventions, including videos and relational agents (RAs), instead of traditional pre-test GC sessions, without providing specifics about community engagement development, acceptability, or efficacy in oncology settings through a rigorous methodologic strategy as we propose. Given the life-saving benefits of GT, understanding how to effectively educate, empower and test high-risk patients in a culturally acceptable way can move the field forward and reduce persistent racial disparities. This study will address this translational gap. In response to community identified needs and enthusiastic support from cancer patients, relatives and community advocates while also building on our pilot work, we will enroll 428 Black cancer patients meeting national guidelines for GT into a 2-arm randomized controlled trial. This approach may be of particular benefit to hundreds of thousands Black patients and their relatives because they are often unaware of their risks, less likely to have a provider discuss their risk and refer them for GT at the time of diagnosis and are not equably garnering the potentially lifesaving benefits of personalized prevention, screening, and treatment. The specific aims are to: 1) Compare the efficacy of a culturally tailored RA vs. Enhanced Usual Care (EUC) on engagement in genetic education and GT uptake; 2) Evaluate the impact of the RA vs. EUC on informed decision-making and psychosocial outcomes; and 3) Explore potential mechanisms by assessing mediators and moderations of effectiveness. Data from this trial can be used to guide clinical practice and policy decisions for advancing cancer health equity and improving access to genetic education and GT. If successful, this approach could be applied to other cancers and chronic conditions.

遗传性癌症的基因检测和相关的保健服务并没有覆盖所有阶层， 人口公平。基因组护理中的种族差异是深刻的，持久的，并不断增长。低于30% 的高风险癌症患者被转介进行生殖细胞GT，转介率和检测率明显降低 少数民族，尤其是黑人。癌症幸存者的GT可以直接告知治疗 在癌症进展或治疗耐药性之后， 未受影响的亲戚对GC（遗传咨询）和GT的需求继续增加， GT适应症和降低测序成本，但遗传咨询师的供应仍然有限。的 转介到预测试遗传咨询的常规方法是接受GT的常见障碍。此外， 有证据表明，传统的全面的、预先测试的GC不能满足许多幸存者的需要， 尤其是弱势群体。因此， 需要基于基因组的护理， 社区需求，改善可及性，不使稀缺的遗传咨询资源负担过重， 存在的差距。一些医疗保健系统和商业GT实验室使用数字干预， 包括视频和关系代理（RA），而不是传统的预测试GC会话， 关于社区参与发展、可接受性或肿瘤学环境中的疗效的具体信息， 严格的方法论策略。鉴于GT的救生优势，了解如何 以文化上可接受的方式对高危患者进行有效的教育、赋权和检测， 消除和消除长期存在的种族不平等。这项研究将解决这个翻译差距。响应于 社区认同癌症患者、亲属和社区倡导者的需求和热情支持 在我们的试点工作的基础上，我们将招募428名符合国家指导方针的黑人癌症患者， GT纳入一项2组随机对照试验。这种方法可能对数百名 成千上万的黑人患者及其亲属，因为他们往往不知道他们的风险，不太可能有一个 提供者讨论他们的风险，并在诊断时将他们转介给GT， 个性化预防、筛查和治疗的潜在救生益处。具体目标是：1） 比较文化定制的RA与增强的生殖保健（EUC）在参与遗传学研究方面的疗效。 2）评估RA与EUC对知情决策的影响， 心理社会结果;和3）通过评估中介和调节， 有效性该试验的数据可用于指导临床实践和政策决策， 癌症健康公平以及改善遗传教育和遗传学治疗的机会。如果成功，这种方法可能会 适用于其他癌症和慢性疾病。