Document Type

Article

Presentation Date

6-27-2024

Comments

This article is the author’s final published version in JAMA Network Open, Volume 7, Issue 6, 2024, Article number e2417873.

The published version is available at https://doi.org/[insert DOI and hyperlink]. Copyright © 2024 Graetz I et al. JAMA Network Open.

Abstract

IMPORTANCE: Adjuvant endocrine therapy (AET) use among women with early-stage, hormone receptor-positive breast cancer reduces the risk of cancer recurrence, but its adverse symptoms contribute to lower adherence.

OBJECTIVE: To test whether remote monitoring of symptoms and treatment adherence with or without tailored text messages improves outcomes among women with breast cancer who are prescribed AET.

DESIGN, SETTING, AND PARTICIPANTS: This nonblinded, randomized clinical trial (RCT) following intention-to-treat principles included English-speaking women with early-stage breast cancer prescribed AET at a large cancer center with 14 clinics across 3 states from November 15, 2018, to June 11, 2021. All participants had a mobile device with a data plan and an email address and were asked to use an electronic pillbox to monitor AET adherence and to complete surveys at enrollment and 1 year.

INTERVENTIONS: Participants were randomized into 3 groups: (1) an app group, in which participants received instructions for and access to the study adherence and symptom monitoring app for 6 months; (2) an app plus feedback group, in which participants received additional weekly text messages about managing symptoms, adherence, and communication; or (3) an enhanced usual care (EUC) group. App-reported missed doses, increases in symptoms, and occurrence of severe symptoms triggered follow-ups from the oncology team.

MAIN OUTCOMES AND MEASURES: The primary outcome was 1-year, electronic pillbox-captured AET adherence. Secondary outcomes included symptom management abstracted from the medical record, as well as patient-reported health care utilization, symptom burden, quality of life, physician communication, and self-efficacy for managing symptoms.

RESULTS: Among 304 female participants randomized (app group, 98; app plus feedback group, 102; EUC group, 104), the mean (SD) age was 58.6 (10.8) years (median, 60 years; range, 31-83 years), and 60 (19.7%) had an educational level of high school diploma or less. The study completion rate was 87.5% (266 participants). There were no statistically significant differences by treatment group in AET adherence (primary outcome): 76.6% for EUC, 73.4% for the app group (difference vs EUC, -3.3%; 95% CI, -11.4% to 4.9%; P = .43), and 70.9% for the app plus feedback group (difference vs EUC, -5.7%; 95% CI, -13.8% to 2.4%; P = .17). At the 1-year follow-up, app plus feedback participants had fewer total health care encounters (adjusted difference, -1.23; 95% CI, -2.03 to -0.43; P = .003), including high-cost encounters (adjusted difference, -0.40; 95% CI, -0.67 to -0.14; P = .003), and office visits (adjusted difference, -0.82; 95% CI, -1.54 to -0.09; P = .03) over the previous 6 months compared with EUC participants.

CONCLUSIONS AND RELEVANCE: This RCT found that a remote monitoring app with alerts to the patient's care team and tailored text messages to patients did not improve AET adherence among women with early-stage breast cancer; however, it reduced overall and high-cost health care encounters and office visits without affecting quality of life.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03592771.

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Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.

Additional Files
zoi240584supp1_prod_1718729285.88268.pdf (913 kB)
Supplement 1 - Trial Protocol
zoi240584supp2_prod_1718729285.93769.pdf (171 kB)
Supplement 2 - eFigure, eTable 1, eTable 2
zoi240584supp3_prod_1718729286.01254.pdf (13 kB)
Supplement 3 - Data Sharing Statement

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