Abstract C22: Study protocol: A randomized controlled trial of patient navigation to reduce cancer health disparities in Latina breast cancer survivors
Authors: Ramirez Amelie G. , Muñoz Edgar , Stoerkel Erika L. , Sintes-Yallen Amanda , Holden Alan E.C. 
Published: May 2016

Abstract
Background: Breast cancer is the leading cancer among women of Hispanic origin. It is expected to continue to be the leading cancer as the US Hispanic population grows towards 31% of all US citizens by 2060. Hispanic women (Latinas) experience significant disparities in breast cancer services resulting in lower breast cancer survival rates than the general population after accounting for differences in age, cancer stage and other factors. Root- causes of disparities are multifactorial, including diagnostic and treatment delays, language, social, and financial barriers, and poor communication between patients and health care providers. Patient navigation (PN) is a potential intervention to address cancer disparities. We conducted “Staying Healthy,” a two-year, two-arm randomized controlled trial testing the effectiveness of a PN intervention to increase Latinas' access to cancer screening, diagnosis and care.
Methods/Design: Staying Healthy is a Susan G. Komen for the Cure-sponsored randomized controlled trial (RCT) of PN targeting Latina breast cancer survivors (BCS). The goal is to develop a model of PN that will eliminate cancer care disparities in Latinas by addressing barriers to cancer care and promoting patient self-efficacy. The intervention uses trained navigators from the target community. Participants are randomly assigned to receive either usual PN services or intervention (PN+) services. In addition to usual participant-initiated PN services, PN+ participants receive tailored educational materials, regular personalized assistance including phone calls, meetings, and coordination of targeted care. Dependent measures include compliance with health care recommendations, screening practices and general and breast cancer-specific quality of life (QOL).
Results: Baseline analyses have been performed on 120 enrolled participants. Results indicate 57% had Medicare or Medicaid insurance coverage; they average 57.3±9.5 years of age; 38% are Spanish monolingual, 58% US born, 47% are married or living together and 87% are parents. Additionally, more than three-fifths (61%) report an annual income below $25,000. They are 3.6±2.8 years post-diagnosis and 3.2±2.6 years post-primary treatment. Finally, study participants report general health-related (Functional Assessment of Cancer Therapy-General, FACT-G: 82±16.8) and breast cancer-specific QOL (FACT-B: 107±21.4). Lower levels of distress are significantly correlated with higher QOL measures after controlling for the effects of age, time since primary treatment, and acculturation.
Discussion: Results show that levels of distress and QOL are inversely associated independently of other factors such as age, time since primary treatment and degree of acculturation. Interventions to reduce cancer health disparities may be an effective approach for patient navigation.
Citation Format: Amelie G. Ramirez, Edgar Muñoz, Erika L. Stoerkel, Amanda Sintes-Yallen, Alan E.C. Holden. Study protocol: A randomized controlled trial of patient navigation to reduce cancer health disparities in Latina breast cancer survivors. [abstract]. In: Proceedings of the Eighth AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Nov 13-16, 2015; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2016;25(3 Suppl):Abstract nr C22.