Addressing Genomic Disparities in Cancer Survivors

解决癌症幸存者的基因组差异

基本信息

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
项目类别：
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

项目摘要

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.

遗传癌和相关卫生服务的基因检测（GT）并未达到所有领域人口平等。基因组护理中的种族差异是深刻，持久和成长的。小于30％高危癌症患者被转诊为种系GT，转诊和测试率明显较低在种族少数群体中，尤其是黑人。癌症幸存者的GT可以直接告知治疗遵循进展或治疗耐药性，并可以促进癌症的原发性和继发性预防他们未受影响的亲戚。随着GC（遗传咨询）和GT的需求，随着扩大 GT指示和降低测序成本但遗传咨询师的供应仍然有限。这转介到预测试遗传咨询的常规方法是接受GT的常见障碍。更远，有证据表明，传统的综合测试前GC不满足许多幸存者的需求，特别是服务不足的少数民族。因此，新的模型需要基于基因组的护理社区需求，改善访问权限，不覆盖稀缺的遗传咨询资源，并且不会扩大现有差异。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（RAS），而不是传统的测试前GC会话，而无需提供有关社区参与发展，可接受性或功效的细节正如我们建议的那样，严格的方法论策略。考虑到GT的挽救生命的好处，了解如何有效地教育，赋权和测试高风险患者以文化可接受的方式可以移动该领域转发并减少持续的种族差异。这项研究将解决这一翻译差距。响应社区确定了癌症患者，亲戚和社区拥护者的需求和热情支持在我们的飞行员工作的同时，我们将注册428名黑人癌症患者 GT进入2臂随机对照试验。这种方法可能特别有益于数百种成千上万的黑人患者及其亲戚，因为他们常常不知道自己的风险，而不太可能拥有提供者讨论他们的风险，并在诊断时将其引用GT，并且没有同等地获得个性化预防，筛查和治疗的潜在挽救救生益处。具体目的是：1）比较具有文化量身定制的RA与增强的常规护理（EUC）对遗传的疗效教育和GT吸收； 2）评估RA与EUC对知情决策和社会心理结果； 3）通过评估调解者和适度的探索潜在机制效力。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并改善获得基因教育和GT的机会。如果成功的话，这种方法可能是应用于其他癌症和慢性病。