A novel community-based study to address disparities in hypertension and colorectal cancer: a study protocol for a randomized control trial

Authors

Joseph Ravenell, New York University School of MedicineFollow
Hayley Thompson, Karmanos Cancer Institute, Wayne State University School of MedicineFollow
Helen Cole, Center for Healthful Behavior Change, New York University School of MedicineFollow
Jordan Plumhoff, Center for Healthful Behavior Change, New York University School of MedicineFollow
Gia Cobb, Center for Healthful Behavior Change, New York University School of MedicineFollow
Lola Afolabi, Center for Healthful Behavior Change, New York University School of MedicineFollow
Carla Boutin-Foster, Weill Cornell Medical College, Cornell UniversityFollow
Martin Wells, Industrial and Labor Relations School, Cornell UniversityFollow
Marian Scott, St. Luke’s and Roosevelt HospitalsFollow
Gbenga Ogedegbe, Center for Healthful Behavior Change, New York University School of MedicineFollow

Document Type

Article

Abstract

Abstract

Background

Black men have the greatest burden of premature death and disability from hypertension (HTN) in the United States, and the highest incidence and mortality from colorectal cancer (CRC). While several clinical trials have reported beneficial effects of lifestyle changes on blood pressure (BP) reduction, and improved CRC screening with patient navigation (PN), the effectiveness of these approaches in community-based settings remains understudied, particularly among Black men.

Methods/design

MISTER B is a two-parallel-arm randomized controlled trial that will compare the effect of a motivational interviewing tailored lifestyle intervention (MINT) versus a culturally targeted PN intervention on improvement of BP and CRC screening among black men aged ≥50 with uncontrolled HTN who are eligible for CRC screening. Approximately 480 self-identified black men will be randomly assigned to one of the two study conditions. This innovative research design allows each intervention to serve as the control for the other. Specifically, the MINT arm is the control condition for the PN arm, and vice-versa. This novel, simultaneous testing of two community-based interventions in a randomized fashion is an economical and yet rigorous strategy that also enhances the acceptability of the project. Participants will be recruited during scheduled screening events at barbershops in New York City. Trained research assistants will conduct the lifestyle intervention, while trained community health workers will deliver the PN intervention. The primary outcomes will be 1) within-patient change in systolic and diastolic BP from baseline to six months and 2) CRC screening rates at six months.

Discussion

This innovative study will provide a unique opportunity to test two interventions for two health disparities simultaneously in community-based settings. Our study is one of the first to test culturally targeted patient navigation for CRC screening among black men in barbershops. Thus, our study has the potential to improve the reach of hypertension control and cancer prevention efforts within a high-risk population that is under-represented in primary care settings.

Trial registration

ClinicalTrials.gov, NCT01092078

Disciplines

Circulatory and Respiratory Physiology | Gastroenterology | Oncology

Recommended Citation

Ravenell et al.: A novel community-based study to address disparities in hypertension and colorectal cancer: a study protocol for a randomized control trial. Trials 2013 14:287.