Patient navigation and clinical trial participation: A randomized controlled trial design

Melissa Kurtz Uveges; Dina George Lansey; Olive Mbah; Tamryn Gray; Lisa Sherden; Jennifer Wenzel

doi:10.1016/j.conctc.2018.09.003

Patient navigation and clinical trial participation: A randomized controlled trial design

Contemp Clin Trials Commun. 2018 Sep 22:12:98-102. doi: 10.1016/j.conctc.2018.09.003. eCollection 2018 Dec.

Authors

Melissa Kurtz Uveges¹, Dina George Lansey², Olive Mbah³, Tamryn Gray⁴, Lisa Sherden², Jennifer Wenzel⁵

Affiliations

¹ Harvard Medical School, Center for Bioethics, 641 Huntington Avenue, Boston, MA, 02115, USA.
² Department of Oncology, Johns Hopkins School of Medicine, 1600 North Wolfe Street, Baltimore, MD, 21205, USA.
³ The University of North Carolina at Chapel Hill, School of Public Health, 135 Dauer Drive, Chapel Hill, NC, 27599, USA.
⁴ Dana-Farber/Harvard Cancer Center, 450 Brookline Avenue, Boston, MA, 02215, USA.
⁵ Department of Acute and Chronic Care, Johns Hopkins School of Nursing, 525 North Wolfe Street, Baltimore, MD, 21205, USA.

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.

Keywords: Cancer clinical trials; Decision making; Patient navigation.