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Abstract Background: Hormone therapy (HT) is highly effective for nearly all breast cancer patients with hormone receptor-positive tumors, which are about 80% of all breast cancer diagnoses. Long-term use of HT reduces cancer recurrence rates and cuts the risk of mortality nearly in half during the second decade after diagnosis. Despite proven benefits, 33% of women who are prescribed HT do not take it as prescribed by their doctor (80% take their daily dosage). Latina patients are disproportionately affected by Social Determinants of Health (SDoH) that keep them from adhering to HT and are at higher risk of breast cancer recurrence and mortality. Objective: The goal of this 4-year randomized controlled study is to assess the effectiveness of the existing bilingual, culturally tailored, interactive HT Helper App, in combination with patient navigation (PN), on improving adherence to HT among Latina breast cancer patients experiencing SDoH barriers, i.e., income, health insurance, education, health literacy, and language, that impacts their medication adherence. This theory-based intervention will increase patient education, enhance self-efficacy, facilitate communication with the medical team and coordination of resources to address SDoH barriers and help patients develop self-care skills for optimal adherence to HT, ensuring patients the most equitable treatment outcomes possible, including improvement in quality of life, survival, and life expectancy. Study Design. The proposed study involves a parallel 3-group randomized controlled trial with 5-time assessments (baseline, 3, 6, 12, and 18 months) and will enroll 159 breast cancer patients who are prescribed HT and are attending the breast clinic at the Mays Cancer Center at UT Health San Antonio. Intervention components are based on Social Cognitive Theory and elements of Motivational Interviewing. Methods: We will compare the effectiveness of 3 groups on HT adherence: 1) the HT Helper App + PN group vs. the PN alone group vs. the usual care group, and will assess the effect of each study condition on patient self-efficacy to identify side effects, use self-care to manage side effects, and communicate with the medical team. We hypothesize that the HT Helper App + PN and the PN alone groups will have greater rates of HT adherence and higher patient self-efficacy than the usual care group, with the HT Helper App + PN achieving better results than both PN alone and the usual care groups. Conclusion: This proposed multi-level intervention involving a unique combination of mHealth technology + PN has the potential to improve adherence to HT by addressing SDoH and promote equitable breast cancer outcomes, including reduced recurrence and improved quality of life, overall survival and life expectancy among underserved Latina patients. The anticipated outcome is a scalable, evidence-based, and easily disseminated intervention with potentially broad use to patients using oral anticancer medications. Citation Format: Patricia Chalela, Vivian Cortez, Sandra Sivak, Armida Flores, Martha De La Mora, Zully Garcia, Byeongyeob Choi, Edgar Muñoz, Qurathul Ahmed, Audrey Cordova, Maria I Sung-Cuadrado, Asra Aslam, Cliff Despres, Alyssa Gonzales, Virginia G Kaklamani, Kate I. Lathrop, Marcela Mazo Canola, Devasena Inupakutika, David Akopian, Amelie G. Ramirez. HT Helper Study: A phone application + patient navigation to improve medication adherence among Latina breast cancer patients experiencing social determinants of health abstract. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr B117.
Chalela et al. (Sat,) studied this question.