Abstract C104: Breast cancer care at rural serving hospitals in Ethiopia: Improving adherence to endocrine therapy with nurse-based intervention. Study protocol for facility-based cluster randomized controlled trial
Authors: Getachew Sefonias , Addissie Adamu , Wienke Andreas , Enquoselassie Fikre , Taylor Lesley , Jemal Ahmedin , Kantelhardt Eva Johanna 
Published: August 2020

Abstract
Background: The majority of women with breast cancer from low-income countries, including Ethiopia, present with advanced clinical stage, resulting in limited and difficult therapeutic options and high mortality rates. In Ethiopia 70% of breast cancer cases are hormone receptor (HR) positive. Endocrine therapy is highly recommended as treatment; however, the use and adherence of this therapy is low. Recommendations on interventions to improve the adherence of therapy exist from high-resource settings. One recommendation is to utilize a nurse navigator. Our cluster randomized intervention trial aims to evaluate the effectiveness of placing a trained nurse navigator to administer and organize follow-up visits of patients on tamoxifen in 4 rural hospitals over 12 months (n=60).
Method: A cluster randomized intervention trial is carried out to assess patient adherence, perception of illness and therapy, willingness to initiate therapy, and belief in therapy, comparing 4 interventions to 4 control rural hospitals (each n=60 patients) without intervention. Prior to intervention, all patients in the hospitals will be provided tamoxifen therapy free of charge. The hormone receptor status of the breast cancer specimen will be validated prior to the initiation or throughout therapy. The primary outcome is adherence of endocrine therapy. In addition, a facility-based survey will be conducted to assess patients' belief and perception of treatment and illness among patients and providers in the hospitals, to determine the knowledge, lived experience and decision-making processes involved in the initiation of endocrine treatment. The patients' knowledge of breast cancer, endocrine treatment and their extent of social support will be assessed. The data will be collected retrospectively, survey based and prospective repeated measure based with quantitative and qualitative approach. Analysis will be based on an intention-to-treat principle.
Discussion/Results: The trial aims to answer: Does the nursing intervention improve treatment adherence of endocrine therapy compared to those receiving usual care services? What are the factors associated with adherence to endocrine treatment? What is the patients' perception of breast cancer, their willingness to initiate therapy, and the extent of social support?
Discussion: These data are essential to maximize the impact of nurse-based intervention on the adherence, knowledge and belief of therapy among breast cancer patients.
Conclusion: The nurse intervention may reduce disparities in health care services and improve outcomes in breast cancer treatment.
Trial registration: Under process of registration.
Citation Format: Sefonias Getachew, Adamu Addissie, Andreas Wienke, Fikre Enquoselassie, Lesley Taylor, Ahmedin Jemal, Eva Johanna Kantelhardt. Breast cancer care at rural serving hospitals in Ethiopia: Improving adherence to endocrine therapy with nurse-based intervention. Study protocol for facility-based cluster randomized controlled trial [abstract]. In: Proceedings of the Eleventh AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2018 Nov 2-5; New Orleans, LA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl):Abstract nr C104.