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 (GT) 和相关健康服务并未覆盖到所有阶层 人口公平。基因组护理方面的种族差异是深刻的、持久的且不断扩大。低于30% 的高风险癌症患者被转诊进行种系 GT，转诊率和检测率明显较低 少数族裔，尤其是黑人。癌症幸存者的 GT 可以直接指导治疗 进展或治疗耐药后，可以促进癌症的一级和二级预防 他们未受影响的亲戚。随着规模的扩大，对GC（遗传咨询）和GT的需求持续增加 GT 适应症和测序成本不断降低，但遗传咨询师的供应仍然有限。这 转诊至测试前遗传咨询的传统方法是接受 GT 的常见障碍。更远， 有证据表明，传统的全面预测试 GC 不能满足许多​​幸存者的需求， 尤其是服务不足的少数群体。因此，新模型 需要基于基因组的护理来应对 社区需求，改善获取机会，不要使稀缺的遗传咨询资源负担过重，并且不要扩大 现有的差距。一些医疗保健系统和商业 GT 实验室使用数字干预措施， 包括视频和关系代理 (RA)，而不是传统的预测试 GC 会话，无需提供 通过以下方式详细说明肿瘤学环境中社区参与发展、可接受性或功效 正如我们提出的那样，严格的方法策略。鉴于 GT 可以挽救生命，了解如何 以文化上可接受的方式有效地教育、授权和测试高危患者可以推动这一领域的发展 推进并减少持续存在的种族差异。这项研究将解决这一转化差距。作为回应 社区确定了癌症患者、亲属和社区倡导者的需求和热情支持 在试点工作的基础上，我们将招募 428 名符合国家指南的黑人癌症患者 GT 进入 2 组随机对照试验。这种方法可能对数百人特别有利 成千上万的黑人患者及其亲属，因为他们往往不知道自己的风险，不太可能患上 提供者在诊断时讨论他们的风险并转介他们接受 GT，但没有平等地获得 个性化预防、筛查和治疗具有潜在的挽救生命的益处。具体目标是：1） 比较根据文化定制的 RA 与增强型常规护理 (EUC) 在参与遗传方面的功效 教育和 GT 的吸收； 2) 评估 RA 与 EUC 对知情决策的影响 社会心理结果； 3) 通过评估调解者和调节者来探索潜在的机制 效力。该试验的数据可用于指导临床实践和政策决策，以推进 癌症健康公平和改善获得遗传教育和 GT 的机会。如果成功的话，这种方法可能会 适用于其他癌症和慢性病。