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

利益相关者知情的癌症患者预测试视频教育与标准遗传咨询的随机试验：评估对患者、提供者和实践的影响

• 批准号: 10653225
• 负责人: Huma Q Rana
• 金额: $ 79.33万
• 依托单位: DANA-FARBER CANCER INST
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-22 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10653225
• 关键词: Address; Age; Appointment; Behavioral; Breast; COVID-19 pandemic; Cancer Center; Cancer Patient; Caring; Clinic; Clinical; Colorectal; Communication; Communities; Community Practice; Cost Analysis; Costs and Benefits; Counseling; Data; Diagnosis; Disclosure; Disease; Education; Ensure; Environment; Epithelium; Evaluation; Family; Family member; Fostering; Gender; Genetic; Genetic Counseling; Genetic Services; Genomics; Goals; Guidelines; Implementation readiness; Improve Access; Individual; Insurance Coverage; Integrated Health Care Systems; Intervention; Interview; Kidney; Knowledge; Malignant Neoplasms; Measurement; Measures; Medical; Methods; Minority; Modeling; Modernization; Oncology; Operative Surgical Procedures; Outcome; Ovarian; Ovary; Pancreas; Pathogenicity; Patient Outcomes Assessments; Patient-Focused Outcomes; Patients; Probability; Process; Prostate; Provider; Public Health; Recommendation; Research; Resources; Role; Sampling; Schedule; Service delivery model; Services; Standardization; Structure; Surveys; System; Technology; Test Result; Testing; Variant; Wait Time; cancer diagnosis; cancer genetics; cancer predisposition; chatbot; cost; evidence base; genetic counselor; genetic testing; improved; innovation; interest; medical specialties; meetings; melanoma; novel; patient oriented; patient safety; personalized care; psychosocial; racial diversity; randomized trial; safe patient; salivary assay; sarcoma; satisfaction; service delivery; standard of care; success; targeted treatment; telegenetics; testing uptake; trial comparing; tumor; uptake; virtual genetic counseling

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.

项目摘要/摘要 尽管种系基因检测（GGT）对癌症患者的益处有很大的好处，包括通知 治疗（靶向疗法，适当的手术）和家庭成员（级联测试） 将GGT整合到肿瘤学工作流程中不一致，从而导致了很大的护理差距。减少劳动 - 密集，简化的服务交付策略可能会改善对测试的访问，并减轻负担 患病的癌症患者，特别是在资源较少的环境中。该建议直接响应 RFA-HG-20-048因为它衡量了新型遗传咨询实践的功效和可接受性 旨在现代化遗传学护理。该应用程序的总体目标是完善我们的预测癌症 遗传学视频教育和结果依赖性披露（VERDI）干预，比较以患者为中心 维尔第（Verdi）的成果为标准咨询，阐明所需的资源 /成本并描述接受能力 遗传顾问（GCS）准备实施Verdi的准备就绪。提议的理由 研究是，必须通过严格评估对患者和GC的影响来告知替代模型。 这些目标将通过追求三个具体目标来实现：（i）改进和适应维尔第以确保 各种癌症患者的可接受性（II）进行了Verdi与标准遗传的随机试验 通过两个癌症中心及其社区伙伴进行咨询护理，并比较以患者为中心的 结果和（iii）评估Verdi范式对GCS的影响以及为实践提供信息的成本。在目标1中 和2，研究将包括与GGT为癌症的多种情况下不同背景的患者 标准及其常规较少的标准。患者的定性访谈将告知 维尔第，随后对维尔迪与护理标准遗传咨询进行随机试验，并测量 以下以患者为中心的结果：接受干预，测试吸收，满意度，社会心理 影响，知识和家庭交流。 AIM 3将通过半通过半方法分析 结构化的定性访谈随后是全国对GCS的调查，以阐明促进者和障碍 广泛的实现。在此目的下，评估每患者测试成本的成本分析将是 使用随机试验期间收集的数据进行。该应用程序提出的研究是 创新的，因为它使用简单，适应能力的技术与务实的，以患者为中心的技术 不同患者需要标准化过程的方法所告知的方法。强劲的结果 利益相关者，尤其是角色会改变最大的GC。拟议的研究是 重要的是因为它有望提供患者，提供商和系统级别的数据，以告知方法扩展的方法 可以安全有效地获得患病患者的GGT和咨询。最终，这些知识将促进 针对各种医疗状况的遗传和基因组护理的可扩展方法，解决了不断发展的 GC的角色在促进访问权限并兑现个性化护理的承诺的同时。