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Open Access Study protocol

Study Protocol: A randomized controlled trial of patient navigation-activation to reduce cancer health disparities

Samantha Hendren8*, Jennifer J Griggs7, Ronald M Epstein134, Sharon Humiston56, Sally Rousseau14, Pascal Jean-Pierre13, Jennifer Carroll1, Amanat M Yosha1, Starlene Loader1 and Kevin Fiscella123

Author Affiliations

1 University of Rochester Department of Family Medicine, Rochester, NY, USA

2 University of Rochester Department of Community and Preventive Medicine, Rochester, NY, USA

3 James P. Wilmot Cancer Center, Rochester, NY, USA

4 University of Rochester Department of Psychiatry, Rochester, NY, USA

5 University of Rochester Department of Emergency Medicine, Rochester, NY, USA

6 University of Rochester Department of Pediatrics, Rochester, NY, USA

7 University of Michigan Department of Medicine, Ann Arbor, MI, USA

8 University of Michigan Department of Surgery, Ann Arbor, MI, USA

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BMC Cancer 2010, 10:551  doi:10.1186/1471-2407-10-551

Published: 13 October 2010

Abstract

Background

Cancer health disparities affecting low-income and minority patients are well documented. Root-causes are multifactorial, including diagnostic and treatment delays, social and financial barriers, and poor communication. Patient navigation and communication coaching (activation) are potential interventions to address disparities in cancer treatment. The purpose of this clinical trial is to test the effectiveness of an intervention combining patient navigation and activation to improve cancer treatment.

Methods/Design

The Rochester Patient Navigation Research Program (PNRP) is a National Cancer Institute-sponsored, patient-level randomized trial (RCT) of patient navigation and activation, targeting newly-diagnosed breast and colorectal cancer patients in Rochester, NY. The goal of the program is to decrease cancer health disparities by addressing barriers to receipt of cancer care and promoting patient self-efficacy. The intervention uses trained, paraprofessional patient navigators recruited from the target community, and a detailed training and supervisory program. Recruited patients are randomly assigned to receive either usual care (except for baseline and follow-up questionnaires and interviews) or intervention. The intervention patients receive tailored assistance from their patient navigators, including phone calls, in-person meetings, and behind-the-scenes coordination of care. A total of 344 patients have been recruited. Outcomes measured at three month intervals include timeliness of care, patient adherence, patient satisfaction, quality of life, self-efficacy, health literacy, and cancer knowledge.

Discussion

This unique intervention combining patient navigation and patient activation is designed to address the multifactorial problem of cancer health disparities. If successful, this study will affect the design and implementation of patient navigation programs.

Trials Registration

clinicaltrials.gov identifier NCT00496678