Abstract OT2-02-01: Utilization of patient reported outcomes generated by electronic medical record and smart pill bottles with follow up telehealth encounters to improve adherence to adjuvant endocrine therapy in breast cancer patients

Abstract

Abstract Background: The use of adjuvant endocrine therapy (ET) in the form of tamoxifen (TAM) or an aromatase inhibitor (AI) for up to 10 years is the standard of care (SOC) for women with hormone receptor positive (HR+) breast cancer (BC). These agents can reduce recurrence by 30-50% and reduce mortality by approximately 1/3 irrespective of the use of chemotherapy (CT). Many women have difficulty with long-term compliance and persistence due to side effects and may ultimately self-discontinue. In the EBCTCG meta-analysis, evaluating 20 separate trials of adjuvant TAM for 5 years versus no adjuvant TAM, there was an estimated 80% adherence. Other BC trials have demonstrated lower adherence to TAM, dropping to 50% by years 4-5. Additionally, within the first year, discontinuation rates have been reported to be as high as 20-23%. In this investigator-initiated clinical trial we aim to evaluate the utility of one of two interventions a) serial electronic medical record (EPIC) generated patient (pt) reported outcomes (PRO)and pt surveys, OR b) a smart pill bottle, in increasing adherence to adjuvant ET over a 12-month interval during the first 4 years of adjuvant ET. The study also includes research-specific Telehealth (TH) visits when indicated in response to reports of increased toxicity or non-compliance. Methods: This is the Phase II, randomized, open-label, three-arm, multi-site study that will randomize 285 pts ≥18 years of age with stage 0-III HR+ BC in a 1:1:1 fashion with 95 patients in each arm. Arm A includes standard of care (SOC) quarterly visits (in-person or TH) with the treating provider during 12 months follow-up. Arm B is SOC quarterly visits during 12 months follow up, 18 electronic surveys every 3 weeks in between the SOC visits. Arm C is SOC quarterly visits during for 12 months follow up and use of electronic smart pill bottle with daily reminders to take ET. Primary Objective is to evaluate if the intervention of utilization of automated PROs and follow up TH encounters or the utilization of Smart Pill Bottles and follow up TH encounters can improve patient adherence with adjuvant ET within 12 months of study participation during the first 4 years of ET. The secondary objective is to evaluate if these interventions can improve quality of life and decrease side effects of adjuvant ET. The trial is open with 119 patients enrolled at the time of this abstract submission. ClinicalTrials.gov Identifier: NCT04054557 Citation Format: Utilization of patient reported outcomes generated by electronic medical record and smart pill bottles with follow up telehealth encounters to improve adherence to adjuvant endocrine therapy in breast cancer patients [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr OT2-02-01.