Abstract RF1-05: Utilization of ePROs and smart pill bottles to improve adherence to adjuvant endocrine therapy in early-stage breast cancer

Abstract Background: Non-adherence to adjuvant endocrine therapy (ET) remains a significant clinical challenge. Technologies such as smart devices, electronic messaging, and telehealth offer new approaches to improving adherence. We hypothesized that more frequent monitoring with either electronic medical record (EMR) surveys to assess patient-reported outcomes (ePROs) or smart pill bottles would improve adjuvant ET adherence. Methods: In this phase II, multi-site within a single institution, randomized control investigator-initiated clinical trial, 285 patients receiving adjuvant ET within the first four years of an early stage breast cancer diagnosis were randomly assigned (1:1:1) to either A) standard of care monitoring (SOC) with visits every 3 months, B) SOC plus electronic surveys every 3 weeks, or C) SOC plus an interactive smart pill bottle to assess real-time adherence to ET for 12 months. Data indicating non-adherence, desire to stop ET, or severe toxicity triggered research staff follow-up and in-office or telehealth visits. The primary endpoint was ET adherence, defined as prescriptions filled to cover ≥80% of ET doses plus either self-reported ingesting ≥80% of doses (Arm A and B) or smart pill bottle dispense data (Arm C). 95 patients per arm provided 80% power to detect a difference between 65% adherence in the control arm and 85% adherence in each intervention arm with a significance level of 0.025. Secondary analyses included the effects of year of ET (year 1-4), age (≥50 vs