The MISTER B trial is an ongoing randomized controlled trial evaluating motivational interviewing for blood pressure reduction and patient navigation for colorectal cancer screening in black men, with no results reported yet.
RCT (n=480)
Open-label
1:1 individual-level randomization
Yes
Does a motivational interviewing lifestyle intervention or patient navigation intervention improve blood pressure and colorectal cancer screening rates in black men aged ≥50 with uncontrolled hypertension?
This study protocol describes a cross-randomized trial to simultaneously evaluate a lifestyle intervention for hypertension and patient navigation for colorectal cancer screening among black men in barbershops.
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.
Ravenell et al. (Tue,) conducted a rct in Uncontrolled hypertension and need for colorectal cancer screening (n=480). Motivational interviewing tailored lifestyle intervention (MINT) and Culturally targeted patient navigation (PN) vs. Cross-randomized design (each intervention serves as the control for the other) was evaluated on Within-patient change in systolic and diastolic blood pressure and colorectal cancer screening rates at six months. The MISTER B trial is an ongoing randomized controlled trial evaluating motivational interviewing for blood pressure reduction and patient navigation for colorectal cancer screening in black men, with no results reported yet.