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- Title
Remote Monitoring App for Endocrine Therapy Adherence Among Patients With Early-Stage Breast Cancer: A Randomized Clinical Trial.
- Authors
Graetz, Ilana; Hu, Xin; Kocak, Mehmet; Krukowski, Rebecca A.; Anderson, Janeane N.; Waters, Teresa M.; Curry, Andrea N.; Robles, Andrew; Paladino, Andrew; Stepanski, Edward; Vidal, Gregory A.; Schwartzberg, Lee S.
- Abstract
This randomized clinical trial assesses whether a remote monitoring app with or without additional weekly text messages improves adherence to adjuvant endocrine therapy compared with enhanced usual care among patients with early-stage breast cancer. Key Points: Question: Does a remote symptom and medication adherence monitoring app with or without tailored text messages improve outcomes for women with early-stage breast cancer starting adjuvant endocrine therapy (AET)? Findings: In this randomized clinical trial of 304 women, a remote monitoring app combined with text messages did not improve AET adherence in the first year (the primary outcome) but increased symptom management and reduced overall and high-cost health care encounters and office visits (secondary outcomes). The app alone did not significantly affect outcomes. Meaning: In this study, a remote monitoring app along with text messages did not change AET adherence but improved secondary outcomes, such as frequency of high-cost health care encounters, for women with early-stage breast cancer receiving AET. 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
- Subjects
THERAPEUTIC use of antineoplastic agents; CLINICAL drug trials; PATIENT compliance; MOBILE apps; MEDICAL care use; HORMONE receptor positive breast cancer; SELF-efficacy; DATA analysis; RESEARCH funding; ANTINEOPLASTIC agents; STATISTICAL sampling; QUESTIONNAIRES; EVALUATION of medical care; RANDOMIZED controlled trials; DESCRIPTIVE statistics; TELEMEDICINE; COMMUNICATION; PHYSICIAN-patient relations; QUALITY of life; STATISTICS; TEXT messages; CONFIDENCE intervals; DATA analysis software; REGRESSION analysis; EVALUATION
- Publication
JAMA Network Open, 2024, Vol 7, Issue 6, pe2417873
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2024.17873