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Background: The successful use of hormone therapy (HT) has contributed to improved 5-year cause-specific breast cancer survival rates and evidence shows that long-term use produces a larger reduction in recurrence and mortality, with nearly 50% reduction in breast cancer mortality during the second decade after diagnosis. Despite the proven benefits, hormone therapy adherence is suboptimal (less than 80% of daily doses taken) and about 33% of women who are prescribed HT do not take their medication as prescribed and are at increased risk of disease recurrence and increased mortality. Smartphone ownership has increased substantially over the past decade, providing an extraordinary opportunity for innovation in the delivery of tailored interventions to improve patients’ adherence to hormonal therapy. Purpose: We present the design and development process of a theory-based, culturally tailored, interactive mobile app to improve adherence to HT among breast cancer patients to be used in combination with patient navigation in a two-group randomized clinical trial study at the Mays Cancer Center. The intervention group (n= 60) will receive the phone app + patient navigation and the control or usual care group (n=60) will receive the information oncologists provide to patients prescribed HT. Methods: Four focus groups (n=21) were conducted with breast cancer patients and personal semi-structured interviews (n=8) with oncologists, nurses, and patient navigators from the Mays Cancer Center, to assess barriers and facilitators to hormone therapy adherence, key symptoms, app content, and features. Qualitative data informed the initial design and development of app mock-ups; these were assessed with two additional focus groups (n=10). Based on formative research, a functional phone app prototype was developed and beta-tested with five breast cancer patients, minor refinements were made, and the app is ready for recruitment. Results: Inputs from patients and healthcare team members helped to identify specific app content and features. Key themes included the importance of increasing patient education, enhancing self-efficacy, facilitating communication with the medical team and helping patients develop self-care skills to promote optimal adherence to hormone therapy. Specific app features included notification pop-ups, reminders, motivational messages, symptom tracking and management tips, educational content, social networking among patients, communication with a patient navigator, local resources and support groups, and technical support. In addition to colors, background and icon preferences, patients emphasize the need for a user-friendly app that is easy to navigate with clear educational content. Beta-testers found the app easy to use, credible and trustworthy, and their reactions were very positive about app appearance, content, purpose, and usability. Minor technical issues were fixed, and the study app was refined and finalized. Conclusions: An iterative and patient-centered design process was followed to develop a bilingual and interactive mobile app prototype to be used in a randomized control trial. The anticipated outcome is a scalable, evidence-based and easily disseminated intervention with potentially broad use to patients using HT and other oral anticancer agents. Citation Format: Patricia Chalela, Edgar Munoz, Cliff Despres, Pramod Sukumaran, Illeana Tiemann, Victoria Paz, Bianca Gutierrez, Devasena Inupakutika, Sahak Kaghyan, David Akopian. Improving adherence to hormone therapy among breast cancer patients through a mobile app and patient navigation: App development and testing [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS9-38.

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Background: Adjuvant hormonal therapy (HT) is highly effective and appropriate for nearly all women with hormone receptor-positive tumors, making such treatment the most widely prescribed therapy for patients with this type of breast cancer. Despite its proven benefits in reducing cancer recurrence and improving survival, HT adherence is suboptimal (less than 80%). About 33% of patients do not take their medication as prescribed and are at increased risk of disease recurrence and lower survival. Purpose: We will present the development and betatesting of HT Helper, a theory-based, bilingual, interactive mHealth app in combination with patient navigation to improve adherence to HT among patients attending the breast clinic at the Mays Cancer Center, as part of the initial phase of a two-group randomized clinical trial study. Methods: As part of the formative research phase, we conducted 4 focus groups (n=21) with breast cancer patients receiving HT, and personal interviews (n=8) with oncologists, nurses, and patient navigators to assess barriers and facilitators to HT adherence, main side effects, app content, and features. Qualitative data informed the initial design and development of app mock-ups; these were assessed with two additional focus groups (n=10). Based on this feedback, we developed the phone app prototype and beta-tested it for two weeks with breast cancer patients (n=5) and research team members. (n=10). Results: Inputs from patients and healthcare team members helped to identify specific app content and features. Key suggestions included adding: educational content on HT, adherence, side effects and how to stay healthy to enhance management skills; a tool for side effects reporting and tracking and social networking with other patients; reminders and inspirational messages; testimonials from real patients; easy avenues to communicate with the study team; information on local resources including support groups; and technical support information. In addition to app colors and icon preferences, patients emphasized the need for a user-friendly app that is easy to navigate with simple and clear educational content. In general, beta-testers found the app easy to use, credible and trustworthy, and their reactions were very positive about app appearance, content, purpose, and usability. After minor technical issues were fixed, the study app was refined and finalized, and it is ready for recruitment. Conclusion: We followed an iterative and patient-centered design process to develop a bilingual, culturally tailored, and interactive mHealth app to be used in combination with patient navigation in a randomized control trial. The anticipated outcome of this innovative multi-communication intervention is a scalable, evidence-based, easily disseminated intervention with potentially broad use to patients using oral anticancer agents. Citation Format: Edgar Muñoz, Cliff Despres, Pramod Sukumaran, Illeana Tiemann, Bianca Gutierrez, Victoria Paz, Devasena Inupakutica, Sahak Kaghyan, David Akopian, Amelie G. Ramirez, Patricia Chalela. HT Helper: mHealth app to promote hormone therapy adherence among breast cancer patients [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr PR09.

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