392 Adapting a randomized, placebo-controlled pilot study aimed to reduce anxiety symptoms to overcome recruitment barriers

Abstract

OBJECTIVES/GOALS: Minimal human investigations have assessed the effect of synbiotics (combination of pre- and probiotics) on anxiety symptoms, despite evidence from preclinical research. Our study aimed to determine the feasibility of a randomized, placebo-controlled trial utilizing synbiotics to reduce anxiety symptoms in older female breast cancer survivors. METHODS/STUDY POPULATION: We aimed to recruit older female breast cancer survivors experiencing anxiety symptoms to a 4-week randomized, placebo-controlled clinical trial. At commencement of the project, participants were eligible if they : 1) were 50-75 years old; 2) completed primary treatment for breast cancer; 3) were experiencing clinical anxiety symptoms 4) agreed to not change dietary supplements 5) were willing to comply with daily supplement regimen; and 6) were able to read and speak English. Use of anxiolytic or microbiome-altering medications, or changes to anxiety treatment within 4 weeks of enrollment were criteria for exclusion. Due to budgetary limitations, we were unable to recruit from state cancer registries, and instead recruited via newspaper advertisements and flyer distribution. RESULTS/ANTICIPATED RESULTS: One participant has successfully been recruited and completed the duration of the clinical trial, and two others have expressed interest but were deemed ineligible. Barriers in recruitment resulted in the following modifications to protocol: we expanded our eligibility criteria by removing the upper age limit (now 50+ years old) and now are recruiting females with a personal or family history of breast cancer. We partnered with the Spencer Cancer Center of East Alabama Health to aid in recruitment. DISCUSSION/SIGNIFICANCE: Integrative approaches to improved patient outcomes are needed, however, recruitment remains a paramount barrier for clinical trials. Addressing our issues for recruitment has opened eligibility to more individuals and allows us to continue our investigations, answer our research questions, and advance translational science.