Improving adherence to endocrine hormonal therapy among breast cancer patients: Study protocol for a randomized controlled trial

P Chalela, E Munoz, D Inupakutika, S Kaghyan, D Akopian, V Kaklamani, K Lathrop, A Ramirez, P Chalela, E Munoz, D Inupakutika, S Kaghyan, D Akopian, V Kaklamani, K Lathrop, A Ramirez

Abstract

Adjuvant endocrine hormonal therapy (EHT) is highly effective and appropriate for nearly all breast cancer patients with hormone receptor-positive tumors, which represent 75% of all breast cancer diagnoses. Long-term use of EHT reduces recurrence rates and nearly halves the risk of death during the second decade after diagnosis. Despite the proven benefits, about 33% of women receiving EHT do not take their medication as prescribed. This causes an increase in the risk for recurrence and death. To promote adherence to EHT among breast cancer patients, this study will develop and pilot-test an intervention consisting of 1) a bilingual, culturally tailored, personalized, interactive smartphone application (app); and 2) support from a patient navigator. The control group will receive usual care. This 2-group randomized control trial will recruit 120 breast cancer patients receiving EHT at the Mays Cancer Center at UT Health San Antonio. The two-year study will have 3-time assessments (baseline, 3 and 6 months). This theory-based intervention will empower patients' self-monitoring and management. It will facilitate patient education, identification/reporting of side effects, delivery of self-care advice, and simplify communication between the patient and the oncology team. The ultimate goal of this innovative multi-communication intervention is to improve overall survival and life expectancy, enhance quality of life, reduce recurrence, and decrease healthcare cost. The anticipated outcome is a scalable, evidence-based, and easily disseminated intervention with potentially broad use to patients using EHT and other oral anticancer agents.

Keywords: Adherence; Breast cancer; Endocrine hormone therapy; Patient navigation; Smartphone app.

Figures

Fig. 1
Fig. 1
CONSORT flow diagram.
Fig. 2
Fig. 2
Phone App Mockup

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