eREACH: A randomized trial of digital alternatives to genetic counseling for metastatic cancer

ABSTRACT With FDA approval of targeted therapies in patients with germline BRCA1/2-related advanced cancers there is a need to evaluate efficient and effective delivery models for germline cancer genetic testing. We sought to evaluate the effectiveness of replacing traditional pretest and posttest counseling with a genetic counselor (GC) with a digital intervention in patients with metastatic cancers. eREACH is a 4-arm randomized non-inferiority trial with a 2×2 design conducted from 2020-2024 and participants were followed for 6 months. Participants were recruited from the community and academic and community medical sites across the United States. A referred sample of adults with advanced or metastatic breast, prostate, ovarian or pancreatic cancer. The digital pretest intervention consists of 8 modules including purpose of genetic testing and implications of results. The digital post-test intervention consists of 4 modules including test results and explanation of results. The primary endpoint was non-inferiority in change in knowledge and anxiety from baseline to post-disclosure. Secondary analyses evaluated patient-reported outcomes (PROs) such as depression and distress, and moderators of PROs such as socioeconomic status. 229 participants were recruited from 14 states and 37% were male, 17% were non-white, 43% had less than a college education and 21% were from community sites or national recruitment. We met non-inferiority for all short-term PROs for both one visit arms (GC/Digital, Digital/GC). We met non-inferiority for all short-term PROs in the fully digital arm except knowledge which was inconclusive, although differences were small. Uptake of visit 1 was lower in the digital arms, although uptake of testing after visit 1 did not differ between arms. Patients living in poorer areas had greater reductions in anxiety in the visit 1 GC arms and rural patients had greater increase in knowledge in digital arms. Men had greater decreases in anxiety with digital disclosure, while women had greater reductions with GC disclosure. The eREACH patient-centered digital delivery intervention with one GC visit is an evidence-based alternative to two visits with a GC for patients with metastatic cancer. The fully digital model may be acceptable for some patients. Competing Interest Statement Primary financial support for this work was supported by the Basser Center for BRCA and a Research Grant from Astrazeneca ESR-19-20239 (ARB). Clinical Trial NCT04353973 Funding Statement Primary financial support for this work was supported by the Basser Center for BRCA and a Research Grant from Astrazeneca ESR-19-20239. Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Institutional Review Board of the University of Pennsylvania gave ethical approval for this work. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Footnotes Research support: Primary financial support for this work was supported by the Basser Center for BRCA and a Research Grant from Astrazeneca ESR-19-20239. Data Availability All data produced in the present study are available upon reasonable request to the authors