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

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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.