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Clinical Trial Summary

The goal of this behavior change focused, culture-specific, pilot, peer intervention is to target masculinity barriers to medical care (MBMC) considering a range of psychosocial factors associated with uptake of CRC screening (fecal immunochemical test (FIT)) among African-American men. Barbershops will serve as intervention sites and barbers will be trained in the technique of Motivational Interviewing (MI) which will guide the barbers to encourage their clients with culturally relevant messaging to take a FIT kit home and then send to the lab for processing (uptake). The main questions it aims to answer are the feasibility of recruitment, sample size estimation, preliminary efficacy, and the acceptability of barbers to deliver culture-specific messages that aim to overcome masculinity barriers to medical care. Researchers will compare the culture-specific intervention with a control arm, where barbers provide their client an evidenced-based American Cancer Society brochure on colorectal cancer screening to understand if barbers peers using MI and culturally relevant messaging better overcome masculinity barriers to medical care than the barber using the brochure alone.


Clinical Trial Description

The purpose of Dr. Rogers' research plan involves developing and pilot testing a theory-driven, culture-specific intervention that specifically targets masculinity barriers to medical care and colorectal cancer (CRC) uptake among African-American men (ages 45-75). CRC is preventable as screening leads to identification and removal pre-cancerous polyps; however, African-American men consistently have the highest CRC mortality rates across all gender and racial/ethnic groups; and their CRC screening uptake remains low for uncertain reason. Contributing factors are etiologically complex, yet but culture-specific masculinity barriers to care may contribute to low CRC screening uptake among African-American men. Examining masculinity barriers to care is vital as CRC screening may challenge some cultural role expectations and self-representations of African-American men whose tendency is to delay help-seeking medical care. The study's specific aims are to: 1) develop, validate, and test a culture specific measure of masculinity barriers to medical care relative to CRC screening uptake among African-American men; and 2) develop and pilot test a theory-driven, culture-specific intervention that targets masculinity barriers to medical care, psychosocial factors, and CRC screening uptake among African-American men. Barbershops are historically known as culturally appropriate and trusted venues in African-American communities, and are critical for this research as they provide a pathway for reaching African-American men with masculinity barriers to care who are not regularly receiving healthcare services, and in particular, CRC screening. This study and integrated training plan well-position Dr. Rogers to launch an independent investigator career focused on informing culture-specific interventions to eliminate cancer inequities among African-American men. The investigator will conduct research in the metro areas of Salt Lake City (Salt Lake City-Provo-Orem) of Utah; Minneapolis-St. Paul, Minnesota; Columbus, Ohio; and Milwaukee, Wisconsin. African American men's CRC screening rates in UT and Wisconsin are substantially lower than in other states, and the aforementioned metro regions have the largest population of African-Americans in each state. Approach. The investigator proposes a multi-stage mixed methods study (Figure 1), beginning with an exploratory sequential design validating the items for subsequent use in a pilot mixed methods intervention to accomplish aims. For Aim 1 (Years 1-2), the investigator collected and analyzed QUALitative data from 2 sources - focus groups and cognitive interviews - to validate and test a culture-specific scale of masculinity barriers to medical care among African-American men (hereafter called the Masculinity Barriers to Care Scale, MBCS). Next, the investigator administered the MBCS as an online QUANTtitative survey with the target population to evaluate the association between scale scores and CRC screening uptake. For Aim 2 (Years 3-6), the investigator will consider existing evidence-based approaches (e.g., motivation interviewing), the integrated results (QUAL + QUANT) from Aim 1 regarding masculinity barriers to care, and community input to design a novel, culture specific, behavioral intervention - one aimed at increasing CRC screening uptake (fecal immunochemical test; FIT) among African-American men and feasible for delivery in barber shops. The investigator will pilot test the peer intervention in a two-arm cluster randomized intervention (6 barbershops, randomized by site-2 shops in each state, specifically, Wisconsin, Ohio, and Minnesota) to account for differences in barbershop culture and reduce contamination. The primary outcomes for the pilot are recruitment, sample size estimation, preliminary efficacy, and acceptability. The investigator will also conduct post-intervention interviews with participants from both arms to evaluate acceptability (i.e., why and how each arm was or was not successful). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03733197
Study type Interventional
Source Medical College of Wisconsin
Contact
Status Withdrawn
Phase N/A
Start date January 2024
Completion date February 29, 2024

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