A randomized non-inferiority trial of an eHealth delivery alternative for cancer genetic testing for hereditary cancer (eREACH2).

Abstract

10510 Background: Germline cancer genetic testing is a standard evidence-based practice, with established risk reduction and cancer screening guidelines for genetic carriers. Yet, many at-risk patients do not have access to genetic services due in part to a workforce shortage of genetic counselors (GC). The randomized non-inferiority eREACH1 study found that digital delivery of pre-test or post-test counseling (e.g. a 1-visit model) was non-inferior 2-visits with a GC and reduced GC time per patient in patients with metastatic cancer. Outcomes with digital alternatives in the broader population of patients with and without cancer who meet criteria for genetic testing is unknown. Methods: eREACH2 is a randomized 4-arm non-inferiority trial where traditional pre-test (visit 1) and post-test (visit 2) counseling delivered by a GC are replaced with a patient-centered eHealth (digital) intervention in patients with and without cancer who meet national guidelines for germline genetic testing. GC visits were offered by telehealth in the home. Arms include: A (GC/GC), B (GC/digital), C (digital/GC) and D (digital/digital). Those assigned to a digital visit could request a visit with a GC if preferred. All participants have a designated GC directing their care, even if they complete a digital visit. Surveys were completed at baseline (T0), after visit 1 (T1), visit 2 (T2) and 6 months (T3). The primary outcomes are non-inferiority in uptake of genetic services and change in genetic knowledge and general anxiety from T0-T2. Secondary outcomes included uptake of testing (89-92% across arms) and additional cognitive, affective and behavioral outcomes. We used modified non-inferiority ANOVAs and modified equivalency chi-squared tests for hypothesis testing using an intention-to-treat (ITT) and confirmatory per-protocol analyses. Results: 773 participants were recruited from across the US with 49.8% from rural areas and 188-198 per arm. Participants were 20-87 YO (mean 51 YO), 13% were male, 12% were non-white, 29% had less than a college education, and 33% had a personal history of cancer. 584 (76%) patients completed testing (14% had a positive result, 16% had a VUS). In our primary ITT analyses, we met the non-inferiority threshold for uptake of genetic services and all short-term (T0-T2) primary and secondary cognitive and affective outcomes. 3% assigned to digital visit 1 and 9% assigned to digital visit 2 requested a GC. Per-protocol analyses were similar to the ITT results. Conclusions: In this large randomized, nationally recruiting trial of representative patients with and without cancer who are candidates for cancer genetic testing, offering patient-centered digital delivery models is non-inferior to two visits with a GC. This patient-centered digital intervention is an evidence-based alternative delivery model to improve access to and efficiency of cancer genetic testing. Clinical trial information: NCT05427240 .