A Randomized Hybrid Type I effectiveness-implementation study of an Ehealth delivery Alternative for Cancer genetic testing for Hereditary cancer predisposition (eREACH)

针对遗传性癌症易感性的癌症基因检测 (eREACH) 的电子健康交付替代方案的随机混合 I 型有效性实施研究

• 批准号: 10684221
• 负责人: Angela R. Bradbury
• 金额: $ 78.58万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-17 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10684221
• 关键词: Address; Affective; American Society of Clinical Oncology; Area; Behavior; Behavioral; Cancer Advocacy; Clinical; Cognitive; Collaborations; Communication; Communities; Community Practice; Consolidated Framework for Implementation Research; Counseling; Data; Disclosure; Distress; Education; Effectiveness; Eligibility Determination; Evidence based practice; Family history of; Funding; Future; Genetic; Genetic Carriers; Genetic Counseling; Genetic Models; Genetic Services; Health Services Accessibility; Hereditary Malignant Neoplasm; Hybrids; Intervention; Malignant Neoplasms; Malignant neoplasm of ovary; Malignant neoplasm of prostate; Medical; Medical Genetics; Methods; Modeling; National Health Interview Survey; Oncology; Online Systems; Outcome; Participant; Patient Recruitments; Patient-Focused Outcomes; Patients; Pennsylvania; Predisposition; Provider; Randomized; Reaction; Recommendation; Reporting; Research; Risk; Risk Reduction; Sampling; Screening for cancer; Secure; Self Direction; Services; Specialist; Telephone; Test Result; Testing; Time; Uncertainty; United States National Institutes of Health; Visit; arm; behavioral outcome; cancer care; cancer genetics; cancer predisposition; clinical practice; clinically significant; design; eHealth; effectiveness evaluation; effectiveness/implementation study; future implementation; genetic counselor; genetic testing; implementation barriers; improved; interest; malignant breast neoplasm; novel; patient population; precision medicine; process evaluation; programs; provider communication; recruit; screening; screening guidelines; sociodemographic factors; telegenetics; testing uptake; treatment as usual; uptake; videoconference

Germline cancer genetic testing has become a standard evidence-based practice, with established risk reduction and cancer screening guidelines for genetic carriers. Yet, access to genetic specialists is limited in many areas in the US, and <20% of eligible patients with a personal or family history of breast or ovarian cancer complete genetic testing. Thus, there is an urgent need to consider alternative delivery models to increase access and uptake of genetic testing, while maintaining adequate patient cognitive, affective and behavioral outcomes. Our research has shown that providing remote services increases uptake of genetic testing in community practices increases uptake of genetic testing. Preliminary data from our ongoing NIH-funded RESPECT study has revealed high interest in a web-based eHealth alternative to traditional pre-test counseling and no significant no differences in pre- and post-disclosure outcomes when the web-based eHealth intervention is utilized as compared to participants who received traditional pre-test genetic counselor. To address the clinically significant need for alternative delivery models to increase access and uptake of cancer genetic testing, while maintaining adequate patient cognitive, affective and behavioral outcomes, we propose to recruit a nationally diverse “real- world” sample of 1000 patients who have access barriers to genetic testing and to conduct a Hybrid Type 1 effectiveness-implementation study to evaluate web-based eHealth delivery alternatives for genetic education and testing. We hypothesize that our theoretically and stakeholder informed eHealth delivery alternatives can provide equal or better uptake of testing and outcomes of genetic testing as compared to the traditional model of pre- and post-test counseling with a genetic counselor. We will partner with several cancer advocacy groups (ASCO, breastcancer.org, Cancer Support Community, Pennsylvania Prostate Cancer Coalition) to recruit patients to this randomized non-inferiority study using a modified 2x2 design (Aims 1-2). In Arm 1, traditional pre-test (visit 1) and post-test (visit 2: disclosure) counseling will be provided remotely through the national Penn Telegenetics Program and compared to delivery arms where patients can complete pre-test and/or disclosure of results through a self-directed web-based eHealth intervention, either in place of, or as an adjunct to traditional genetic counseling. Concurrently, we will conduct a CFIR (Consolidated Framework for Implementation Research)-informed process evaluation to understand moderators of intervention usage and patient outcomes and facilitators and barriers to future implementation and sustainability of this novel eHealth alternative delivery model for genetic services both within and beyond cancer care (Aim 3). We hypothesize that a rigorously developed theoretically and stake-holder informed eHealth delivery alternative provided through a centralized Telegenetics Program has the potential to provide equal or improved patient outcomes, while reducing genetic provider time and providing access to services in community practices where access to genetic services has been limited, providing opportunities to realize the promise of precision medicine in oncology.

生殖系癌症基因检测已成为一种标准的循证实践，具有既定的风险降低 以及遗传携带者的癌症筛查指南。然而，在许多领域， 在美国，<20%有乳腺癌或卵巢癌个人或家族史的合格患者完成了手术 基因检测因此，迫切需要考虑其他提供模式，以增加获得服务的机会， 接受基因检测，同时保持足够的患者认知，情感和行为结果。我们 研究表明，提供远程服务可以增加社区实践中对基因检测的采用 增加基因检测的使用。来自我们正在进行的NIH资助的ECOECT研究的初步数据表明， 显示出对基于网络的电子健康替代传统考前咨询的高度兴趣， 当基于网络的电子健康干预被用作 与接受传统测试前遗传咨询的参与者相比。为了解决具有临床意义的 需要替代的提供模式，以增加癌症基因检测的获得和接受，同时保持 足够的患者认知，情感和行为结果，我们建议招募一个全国性的“真实的- 世界”样本的1000名患者谁有访问障碍的基因检测，并进行混合1型 有效性-实施研究，以评估基于网络的遗传教育电子健康交付替代方案 和试验.我们假设，我们的理论和利益相关者知情的电子健康提供替代品可以 与传统模式相比，提供相同或更好的检测和基因检测结果 基因咨询师的测试前后咨询。我们将与几个癌症倡导团体合作 (ASCO，breastcancer.org，癌症支持社区，宾夕法尼亚州前列腺癌联盟）招募 本随机非劣效性研究采用改良的2x2设计（目的1-2）。在组1中，传统 测试前（访问1）和测试后（访问2：披露）咨询将通过国家宾夕法尼亚大学远程提供 远程遗传学计划，并与患者可以完成预测试和/或披露 通过自我指导的基于网络的电子健康干预，替代或作为传统的辅助手段， 遗传咨询与此同时，我们将开展一项综合实施框架（CFIR 研究）-知情过程评估，以了解干预使用和患者结局的调节因素 和促进者和障碍，以未来的实施和可持续性，这一新的电子卫生替代交付 癌症治疗内外的遗传服务模式（目标3）。我们假设一个严格的 理论上开发了一种通过集中式电子健康服务提供的知情电子健康服务替代方案， 远程遗传学计划有可能提供平等或改善患者的结果，同时减少遗传 提供者的时间和在社区实践中提供服务的机会， 这为实现肿瘤学精准医学的承诺提供了机会。