#CuttingCRC: Barbershop-Based Trial & Colorectal Cancer

NCT03733197 | Withdrawn DMC

• 1 other identifier: 00113679
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Scale development

  Develop, validate, and test a culture-specific measure of masculinity barriers to medical care relative to psychosocial factors and CRC screening uptake among African-American men

  Year 1-2

Secondary Outcomes (1)

• Pilot intervention

  Year 3-6

Study Arms (2)

Culture specific

EXPERIMENTAL

The culture-specific arm "may" entail FIT kits plus barbers as motivational interviewers.

Behavioral: Culture Specific

Control

EXPERIMENTAL

Distribution of CRC screening brochures \& FIT (Fecal Immunochemical Test) kits by barbers

Behavioral: Control

Interventions

Culture Specific BEHAVIORAL

We anticipate the culture-specific arm developed minimally will include two core components: barbers as motivational interviewers, and (2) fecal immunochemical test (FIT) kits distributed by barbers. If we choose this route for the culture-specific arm, preliminary data from our barbers suggest I teach the barbers the MI technique using content that stems from Aim 1 findings. Additional components for this arm may be developed during the APEASE process.

Culture specific

Control BEHAVIORAL

the (control) arm will include an informational CRC screening brochure developed by the American Cancer Society plus a FIT kit distributed by the barbers.

Control

Eligibility Criteria

• Age: 45 Years - 75 Years
• Gender Eligibility Details: Self described as male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \[Phase 1 of 2\]
• Aim 1A: men who 1) self-identified as non-Hispanic Black/African American, 2) were born in the US; 3) were between ages 45-75; 4) had a working telephone; 5) spoke and understood English; \& 6) resided in Utah, Ohio, or Minnesota.
• Aim 1B: men who 1) self-identified as non-Hispanic Black/African American, 2) were born in the US; 3) were between ages 45-75; 4) had a working telephone; 5) spoke and understood English; 6) resided in Utah, Ohio, or Minnesota; \& 7) had a phone with internet capabilities.

You may not qualify if:

• \[Phase 1 of 2\]
• Aim 1A: men who 1) did not self-identify as non-Hispanic Black/African American, 2) were not born in the US; 3) were not between ages 45-75; 4) did not have a working telephone; 5) did not speak and understand English; \& 6) did not reside in Utah, Ohio, or Minnesota.
• Aim 1B: men who 1) did not self-identify as non-Hispanic Black/African American, 2) were not born in the US; 3) were not between ages 45-75; 4) did not have a working telephone; 5) did not speak or understand English; 6) did not reside in Utah, Ohio, or Minnesota; \& 7) did not have a phone with internet capabilities.
• \[Phase 2\]
• \[Phase 2\]

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Related Publications (1)

• Rogers CR, Okuyemi K, Paskett ED, Thorpe RJ Jr, Rogers TN, Hung M, Zickmund S, Riley C, Fetters MD. Study protocol for developing #CuttingCRC: a barbershop-based trial on masculinity barriers to care and colorectal cancer screening uptake among African-American men using an exploratory sequential mixed-methods design. BMJ Open. 2019 Jul 24;9(7):e030000. doi: 10.1136/bmjopen-2019-030000.

  PMID: 31345981 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Charles R Rogers, PhD, MPH, MS

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Mixed Methods Approach

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 7, 2018
• Study Start: January 1, 2024
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Years 1-5