What does this research mean for the field?

The use of smart pill bottles nearly doubled the odds of adhering to adjuvant endocrine therapy compared to standard care (OR 1.97; 95% CI 1.10-3.51, p=0.022). Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.SUPPORTS_CONSENSUS.

What question did this study set out to answer?

To evaluate if electronic patient-reported outcomes (ePROs) and smart pill bottles improve adherence to adjuvant endocrine therapy in early-stage breast cancer.

February 19, 2026

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

Key Result

Use of smart pill bottles increased 12-month adjuvant endocrine therapy adherence to 69.5% vs 53.1% in standard care, nearly doubling odds of adherence (OR 1.97, p=0.022).

Key Points

To evaluate if electronic patient-reported outcomes (ePROs) and smart pill bottles improve adherence to adjuvant endocrine therapy in early-stage breast cancer.
Randomized controlled trial involving 285 patients with early-stage breast cancer.
Participants assigned to three groups: standard of care, SOC plus ePROs, and SOC plus smart pill bottles.
Adherence measured using prescription refill rates and self-reported intake or smart bottle data.
Follow-up initiated for patients showing non-adherence or severe toxicity events.
At 6 months, adherence rates were 70.8% (SOC), 61.7% (SOC + ePROs), and 82.1% (SOC + smart pill bottle).
At 12 months, adherence declined across all groups, with 53.1% (SOC), 45.7% (SOC + ePROs), and 69.5% (SOC + smart pill bottle).
Smart pill bottles significantly improved adherence compared to standard care (OR 1.97, p=0.022).
No significant differences in adherence based on age, race, or type of ET agent were found.

Structured PICO

Does the use of ePROs or smart pill bottles improve adherence to adjuvant endocrine therapy in early-stage breast cancer patients?

Population

285 patients receiving adjuvant endocrine therapy (ET) within the first four years of an early stage breast cancer diagnosis

Intervention

Standard of care plus electronic surveys every 3 weeks (ePROs) OR standard of care plus an interactive smart pill bottle to assess real-time adherence to ET for 12 months

Comparator

Standard of care monitoring (SOC) with visits every 3 months

Outcome

ET adherence, defined as prescriptions filled to cover ≥80% of ET doses plus either self-reported ingesting ≥80% of doses or smart pill bottle dispense datapatient reported

The use of smart pill bottles nearly doubles the odds of adhering to adjuvant endocrine therapy in early-stage breast cancer compared to standard of care monitoring.

Main Result

Absolute Event Rate: 0% vs 0%

Abstract

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 50 years old), baseline ET agent (aromatase inhibitors vs tamoxifen), and race (Black or African American vs White). Results: A total of 285 patients were randomized (96 to SOC, 94 to SOC + ePROs, and 95 to SOC + smart pill bottle). Features including age, ethnicity, stage, baseline ET agent, and year of ET were well-balanced between arms. 173 patients required additional follow-up beyond SOC monitoring, most commonly due to severe/very severe side effects (n=119). At 6 months, adherence on each arm was 70.8%, 61.7%, and 82.1% respectively; at 12 months, adherence was 53.1%, 45.7%, and 69.5%, statistically worse across all arms (OR 0.49; 95% CI 0.40-0.60, p0.001). Compared to Arm A, the use of the smart pill bottle (Arm C) was associated with a significant improvement in adherence (OR 1.97; 95% CI 1.10-3.51, p=0.022), whereas the addition of ePRO monitoring (Arm B) resulted in a numerically worse but statistically insignificant decrease in adherence (OR 0.69; 95% CI 0.40-1.20, p=0.187). In secondary analysis, no difference in adherence was seen when stratified for year of ET (p=0.062), age (OR 1.29, CI 0.71-2.35, p=0.396), baseline ET agent (OR 1.39, CI 0.71-2.73, p=0.340), or race (OR 0.98, CI 0.57-1.71, p=0.952). Conclusion: The use of smart pill bottles nearly doubled the odds of adhering to adjuvant ET compared to standard of care monitoring, suggesting benefit from adoption of this novel technology. Citation Format: S. A. Manobianco, A. Lopez, D. P. Silver, A. P. Scarpaci, R. J. Jaslow, S. Bhattacharya, F. M. Fellin, P. Suresh, A. M. Zibelli, J. Rodriguez, K. C. Degen, S. A. Patel, A. R. MacKenzie, P. Anne, S. B. Rudoler, N. L. Simone, I. Chervoneva, M. Abu-Khalaf. Utilization of ePROs and smart pill bottles to improve adherence to adjuvant endocrine therapy in early-stage breast cancer abstract. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr RF1-05.

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