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#CuttingCRC: Barbershop-Based Trial & Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Culture Specific
Control
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Characteristics of Participants/Inclusion Criteria:

[Phase 1 of 2]

  • Aim 1A: men who 1) self-identify as non-Hispanic Black/African American, 2) were born in the US; 3) are between ages 45-75; 4) have a working telephone; 5) speak and understand English; & 6) reside in Utah, Ohio, or Minnesota.
  • Aim 1B: men who 1) self-identify as non-Hispanic Black/African American, 2) were born in the US; 3) are between ages 45-75; 4) have a working telephone; 5) speak and understand English; 6) reside in Utah, Ohio, or Minnesota; & 7) have a phone with internet capabilities.

Participant Exclusion Criteria:

[Phase 1 of 2]

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Culture specific

    Control

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Pilot intervention
    Develop and pilot test a theory-driven, culture-specific intervention that targets masculinity barriers to medical care, psychosocial factors, and CRC screening update among African-American men.

    Full Information

    First Posted
    November 5, 2018
    Last Updated
    October 17, 2023
    Sponsor
    Medical College of Wisconsin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03733197
    Brief Title
    #CuttingCRC: Barbershop-Based Trial & Colorectal Cancer
    Official Title
    Developing a Barbershop-Based Trial on Masculinity Barriers to Care and Colorectal Cancer Screening Uptake Among African-American Men Using a Mixed Methods Approach
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2024 (Anticipated)
    Primary Completion Date
    December 15, 2024 (Anticipated)
    Study Completion Date
    March 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical College of Wisconsin

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Mixed Methods Approach
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    68 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Culture specific
    Arm Type
    Experimental
    Arm Description
    The culture-specific arm "may" entail FIT kits plus barbers as motivational interviewers.
    Arm Title
    Control
    Arm Type
    Experimental
    Arm Description
    Distribution of CRC screening brochures & FIT (Fecal Immunochemical Test) kits by barbers
    Intervention Type
    Behavioral
    Intervention Name(s)
    Culture Specific
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Control
    Intervention Description
    the (control) arm will include an informational CRC screening brochure developed by the American Cancer Society plus a FIT kit distributed by the barbers.
    Primary Outcome Measure Information:
    Title
    Scale development
    Description
    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
    Time Frame
    Year 1-2
    Secondary Outcome Measure Information:
    Title
    Pilot intervention
    Description
    Develop and pilot test a theory-driven, culture-specific intervention that targets masculinity barriers to medical care, psychosocial factors, and CRC screening update among African-American men.
    Time Frame
    Year 3-6

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Gender Eligibility Description
    Self described as male
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Characteristics of Participants/Inclusion Criteria: [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. Participant Exclusion Criteria: [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] Inclusion: For Aim 2, our pilot intervention Eligibility Criteria & Recruitment includes 60 non-Hispanic Black/African-American male participants who: 1) have never completed CRC screening; 2) are 45-75 years old; 3) were born in the U.S.; 4) reside in Minnesota, Ohio, or Wisconsin; 5) have a telephone with internet, and 6) speak English. As a feasibility intervention, sample size is not based on the power to detect a certain effect size. Rather, n = 60 (30 per arm) was chosen based on practical considerations (e.g., cost, recruitment). With the assistance of barbers and culture-specific marketing materials, we will recruit at least five participants per week from six intervention participation sites (barbershops). [Phase 2] Exclusion: For Aim 2, our pilot intervention Eligibility Criteria & Recruitment excludes men who are not Non-Hispanic Black/African-American as well as those who: 1) have never completed CRC screening; 2) are not 45-75 years old; 3) were not born in the U.S.; 4) do not reside in Minnesota, Ohio, or Wisconsin; 5) do not have a telephone with internet, and 6) do not speak English.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Charles R Rogers, PhD, MPH, MS
    Phone
    414-955-8051
    Email
    crrogers@mcw.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kelly K. Rifelj, MPA
    Phone
    414-955-7642
    Email
    krifelj@mcw.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Charles R Rogers, PhD, MPH, MS
    Organizational Affiliation
    Medical College of Wisconsin
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Sharing de-identified participant data stemming from focus groups, cognitive interviews, surveys, intervention arms, and post trial interviews.
    IPD Sharing Time Frame
    Years 1-5
    IPD Sharing URL
    https://cuttingcrc.com
    Citations:
    PubMed Identifier
    31345981
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    #CuttingCRC: Barbershop-Based Trial & Colorectal Cancer

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