A Stakeholder Informed Randomized Trial of Pretest Video Education vs Standard Genetic Counseling for Cancer Patients: Evaluating the Impact on Patients, Providers and Practices

项目摘要/摘要 尽管生殖系基因测试(GGT)对癌症患者的好处是公认的，包括告知 治疗(靶向治疗，适当的手术)和家庭成员(层叠检测)，已经有 GGT与肿瘤学工作流程的整合不一致，导致护理方面存在重大缺口。更少的劳动力- 密集、简化的服务交付策略可能会改善检测的可及性，并减轻 患病的癌症患者，特别是在资源不那么丰富的环境中。这项提议直接回应了 RFA-HG-20-048，因为它衡量了新的遗传咨询做法的有效性和可接受性 旨在使基因护理现代化。这个应用程序的总体目标是改进我们的预测癌症 遗传学视频教育和结果依赖披露(Verdi)干预，比较以患者为中心 威尔第对标准咨询的结果，阐明所需的资源/成本，并描述接受度 并为遗传顾问(GC)实施威尔第语言做好准备。建议的理由是 研究表明，替代模型必须通过对患者和GC的影响进行严格评估来提供信息。 这些目标将通过追求三个具体目标来实现：(1)改进和调整威尔第语，以确保 不同癌症患者的可接受性(II)进行Verdi与标准基因的随机试验 通过两个癌症中心及其社区合作伙伴提供咨询服务，并比较以患者为中心 评估结果和(Iii)评估威尔第范式对GC的影响和为实践提供信息的成本。在AIMS 1中 2、这些研究将包括不同背景的患者，这些患者患有GGT所针对的癌症 标准的和那些不是常规的。对患者的定性访谈将有助于完善 威尔第，随后进行了威尔第与标准护理遗传咨询的随机试验，测量 以下以患者为中心的结果：接受干预、测试摄取、满意度、心理社会 影响力、知识和家庭沟通。目标3将使用混合方法分析通过半 有组织的定性访谈，然后对地方政府进行全国调查，以阐明促进者和障碍 广泛实施。在这一目标下，将进行一项成本分析，评估每名测试患者的成本 使用在随机试验期间收集的数据进行。这项申请中提出的研究是 创新是因为它使用了简单、适应性强的技术，并结合了务实、以患者为中心的 根据不同患者的需求制定标准化流程的方法。所有人都取得了强劲的成果 衡量利益相关者，特别是角色变化最大的地方政府。拟议的研究是 意义重大，因为预计它将提供患者、提供者和系统级别的数据，为扩展提供参考 安全有效地为病人提供GGT和咨询服务。最终，这些知识将促进 可扩展的遗传和基因组学方法可满足各种医疗条件，解决不断发展的 在促进获得更好的机会和提供个性化护理承诺的同时，发挥一般保健人员的作用。

PROJECT SUMMARY/ABSTRACT Despite the well-established benefits of germline genetic testing (gGT) for cancer patients including informing treatment (targeted therapies, appropriate surgery) and family members (cascade testing), there has been inconsistent integration of gGT into oncology workflows leading to significant gaps in care. Less labor- intensive, streamlined service delivery strategies may improve access to testing for and reduce the burden on sick cancer patients particularly in less resource-rich environments. This proposal is directly responsive to RFA-HG-20-048 because it measures the efficacy and acceptability of novel genetic counseling practices aimed at modernizing genetics care. The overall objectives in this application are to refine our pretest cancer genetics Video Education and Result-Dependent dIsclosure (VERDI) intervention, compare patient-centered outcomes of VERDI to standard counseling, elucidate required resources / costs and delineate the receptivity and readiness for implementation of VERDI by genetic counselors (GCs). The rationale for the proposed research is that alternative models must be informed by rigorous evaluation of effects on patients and GCs. These goals will be accomplished by pursuing three specific aims: (i) refine and adapt VERDI to ensure acceptability among diverse cancer patients (ii) conduct a randomized trial of VERDI vs standard genetic counseling care through two cancer centers and their community partners and compare patient-centered outcomes and (iii) evaluate the impact of the VERDI paradigm on GCs and costs to inform practice. In Aims 1 and 2, the studies will include patients of diverse backgrounds in several settings with cancers for which gGT is standard and those for which it is less routine. Qualitative interviews of patients will inform the refinement of VERDI, followed by a randomized trial of VERDI vs standard of care genetic counseling with measurement of the following patient-centered outcomes: receipt of intervention, testing uptake, satisfaction, psychosocial impact, knowledge and family communication. Aim 3 will use a mixed-methods analysis through semi- structured qualitative interviews followed by a national survey of GCs to elucidate facilitators and barriers to widespread implementation. Under this aim, a cost analysis evaluating cost-per-patient tested will be performed using data collected during the randomized trial. The research proposed in this application is innovative because it uses simple, adaptable technology combined with a pragmatic, patient-centered approach informed by the needs of diverse patients to standardize processes. Robust outcomes of all stakeholders, especially GCs whose role would change the most are measured. The proposed research is significant because it is expected to provide patient, provider and systems level data to inform ways to expand access to gGT and counseling for ill patients safely and effectively. Ultimately, this knowledge will foster scalable approaches to genetic and genomics care for a variety of medical conditions, address the evolving role of GCs while promoting improved access and delivering on the promise of personalized care.