Introduction: Approximately 75% of stage I-III breast cancers are hormone receptor (HR) positive for which the standard of care is 5-10 years of adjuvant endocrine therapy, which has been shown to reduce recurrences and improve survival. Unfortunately, up to 40% of patients may not take the prescribed medication daily or may discontinue it early. Mobile health technology provides an opportunity to develop new innovative tools to identify women who are not taking medication as prescribed, to understand their barriers for adherence and to facilitate communication with providers to improve adherence.
Methods: The objective of the BETA study was to develop a new bi-directional text messaging application that simultaneously assesses patient adherence to endocrine therapy and provides direct communication to the provider team. Our primary endpoint was to assess feasibility of the application and the secondary endpoints included adherence, side effects and their severity, and quality of life (QOL). The intervention consisted of 3 types of text messages to which patients responded: 1) daily, evaluating adherence, 2) weekly, evaluating medication-related side effects and their severity, and 3) monthly, evaluating barriers to taking the medication. After 3 months of participation, patients completed surveys assessing the tolerability and financial burden of the intervention and adherence to medication. Patients were eligible if they had stage I-III, HR-positive breast cancer, owned a cell phone, and were initiating endocrine therapy. Target enrollment is 100 patients. For comparison, 100 consecutive patients meeting the above criteria were identified retrospectively as historical controls; adherence was assessed via chart review.
Results: Between November 2014 and May 2015, 62 patients (mean age 53.5 years) were enrolled and 25 had completed the study. Of those approached, 66% participated. Of those who completed the study, the application was found to be helpful by 63%; specifically, 76% felt the intervention was a reminder to take the medication, 96% felt it was easy to use, and 71% wanted to continue receiving text messages after the study ended. On average, patients spent 12 minutes with the application per week, 0% felt it took up too much time, and only 1 patient incurred text messaging fees. No patients withdrew from the study and only 1 patient did not adhere to treatment (as defined by 80% adherence). None of the enrolled patients discontinued endocrine therapy, compared to 9% of historical controls. Side effects were common: hot flashes/night sweats (61% of patients), joint aches/pains (56%), and vaginal symptoms (29%) were reported. Severe side effects (reported by 29% of patients) prompted a return phone call to the patient. The study is ongoing and final results will be available by December 2015.
Conclusion: We developed a new bi-directional text messaging intervention to assess adherence to endocrine therapy that provides real-time feedback to providers. Patients found the application helpful, easy to use, and not time consuming. Our tool is scalable for large population-based trials.
Citation Format: Epstein LN, Jhaveri AP, Han G, Abu-Khalaf MM, Hofstatter EW, Sanft TB, DiGiovanna MP, Silber AL, Adelson KB, Chung GG, Pusztai L, Gross CP, Mougalian SS. Development of an interactive text messaging tool to improve adherence with adjuvant endocrine therapy: Breast cancer endocrine therapy adherence (BETA) pilot study. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P5-11-03.