Abstract
BACKGROUND: To our knowledge, no published studies utilizing a randomized controlled design have examined the efficacy of patient navigation for improving clinical trial enrollment. METHODS: This patient navigation and clinical trial participation study is a randomized controlled trial to assess the effect of a patient navigator on enrollment into therapeutic cancer clinical trials. Participants are randomly assigned to high intensity, patient navigator-delivered patient educational materials (PEM) and needs assessment vs. low intensity patient navigation (patient navigator-delivered patient educational materials [PEM] alone). Discussion: Effective enrollment strategies may include utilization of patient navigators as away to meet individual needs, barriers, and concerns of participants enrolled in clinical trials.