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The study intervention will include a mobile phone two-way text message application. Each prompt described below will generate either a yes (Y)/no (N) or ABCDE(F) response from patients. Each response will generate further prompts resulting in either notification for providers to call patients or relevant phone numbers for patients to call for assistance.

Two-way text messaging application addressing adherence with adjuvant endocrine therapy

Text Message Application

Sarah Mougalian, MD

Pilot study to assess feasibility and patient acceptance of a text message cell phone application for patients with stage I-III, hormone receptor positive breast cancer who start adjuvant endocrine therapy.

Approximately 75% of breast cancers express the estrogen and/or progesterone receptor (hormone receptors). The standard of care for women with hormone receptor positive breast cancer is five to ten years of adjuvant endocrine therapy with drugs such as tamoxifen or aromatase inhibitors (AIs). In women with stage I-III breast cancer, treatment with adjuvant endocrine therapy has been shown to reduce recurrences by 30-50% and improve survival. Unfortunately, it is estimated from large population databases that up to 35-40% of patients may discontinue adjuvant endocrine therapy before completing the recommended 5 years for various reasons, and non-adherence may reduce survival.

The current protocol is a pilot study in women with hormone receptor positive breast cancer who are beginning adjuvant endocrine therapy, the purpose of which is to assess the feasibility of a two-way text messaging application, with goals for a larger randomized control study to assess if the application will increase adherence and therefore improve disease free survival. This application includes daily text message medication reminders and periodic assessment of side effects and barriers to medication adherence and simultaneously offers assistance for treatment related issues. The investigators will collect information on QOL and financial burden during the 3 month period and will correlate these metrics with adherence. This larger randomized control study would be the first such interventional study to increase adherence with adjuvant endocrine therapy in breast cancer in the US. Our larger randomized control trial would provide the first longitudinal prospectively collected information on QOL, financial burden and adherence over the entire 5-year treatment period in the routine clinical practice setting.

Pilot for The Breast Cancer Endocrine Therapy Adherence (BETA) Trial

Pilot for The Breast Cancer Endocrine Therapy Adherence (BETA) Trial: Efficacy of a Text-messaging Application in Increasing Adherence With Adjuvant Endocrine Therapy for Stage I-III Hormone Receptor Positive Breast Cancer

Using self-report surveys to assess feasibility and patient acceptance of text message program

Adherence rates after 3 months on study, compared with historical controls. Adherence is defined as taking \> 80% of prescribed pills based on self reported adherence questionnaire. This threshold was adopted from the literature. Adherence will also be assessed by checking electronic pharmacy dispensation records when feasible.

Measure quality of life (QOL) and financial burden and correlate with medication adherence

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pilot for The Breast Cancer Endocrine Therapy Adherence (BETA) Trial	NCT02256670	Breast Cancer	Text Message Ap...	18 Years -	Yale University
Pilot for The Breast Cancer Endocrine Therapy Adherence (BETA) Trial	NCT02256670	Breast Cancer	Text Message Ap...	18 Years -	Yale University

Spots Global Cancer Trial Database for text message application