Genetic testing uptake through an enhanced oncology nurse–led intervention in patients with solid tumors (GENESIS): A pilot study.

Abstract

TPS1677 Background: Identification of pathogenic germline variants (PGV) in patients with solid tumors is critical for directing targeted therapies, surveillance, and cascade testing for family members. Despite established National Comprehensive Cancer Network (NCCN) guidelines, uptake of genetic counseling and testing (GCT) remains suboptimal, with recent data suggesting <7% utilization in some cancer populations. Barriers are pronounced in community oncology settings due to limited access to genetic counselors and reliance on physician-initiated referrals. Oncology nurses routinely provide education during systemic therapy initiation, presenting a unique, underutilized touchpoint to bridge this gap. The GENESIS study (NCT06436157) evaluates the feasibility and impact of a novel, nurse-led "enhanced education" intervention on GCT uptake. Methods: This is a single-center, prospective, randomized (1:1) pilot trial conducted at a community cancer center. Eligible participants are adults (≥18 years) with solid tumors (breast, ovarian, prostate, pancreatic, colorectal, and others per NCCN guidelines) who are starting or switching systemic therapy, meet NCCN criteria for GCT, and have no prior germline testing. The study plans to accrue 60 patients. Participants are randomized to the Usual Care arm (standard therapy education; clinician-initiated referral) or the Enhanced Education Intervention arm. In the intervention arm, trained oncology nurses integrate a specific GCT educational module into the standard chemotherapy teaching session. For eligible/agreeable patients, the nurse directly places the GCT referral order and executes a follow-up "nudge" to referral coordinators within one week. The primary endpoint is the percentage of patients proceeding to GCT consultation. Secondary endpoints include GCT referral rates, time from order to consultation, time to testing completion, and implementation feasibility assessed via the Acceptability of Intervention Measure (AIM) and retention rates. Clinical trial information: NCT06436157 .