AzTrials
AzTrials

Colorectal CancerNCT03733197

#CuttingCRC: Barbershop-Based Trial & Colorectal Cancer

A study testing Culture Specific in people with Colorectal Cancer, run by Medical College of Wisconsin.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 45 to 75 years, men onlyHealthy volunteers can take part
Conditions the study is for
Colorectal Cancer
What is being tested?
Culture Specific
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2024to 29 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 75 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

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.

About this study

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

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.

Read the 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).

Being tested
Culture Specific, Control
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Culture SpecificBehavioural

    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.

  • ControlBehavioural

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

Study groups in NCT03733197
Study groupRoleWhat they receive
Culture specificExperimentalThe culture-specific arm "may" entail FIT kits plus barbers as motivational interviewers.
Receives: Behavioral: Culture Specific
ControlExperimentalDistribution of CRC screening brochures \& FIT (Fecal Immunochemical Test) kits by barbers
Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Year 1-2

Secondary outcomes (1)
  1. 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.

    Measured: Year 3-6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2018
  2. Study startJan 2024 (estimated)
  3. Primary completion29 Feb 2024
  4. Study completion29 Feb 2024

Why it stopped: PI no longer employed at institutuion

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Mixed Methods Approach
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03733197
Sponsor's protocol ID
00113679
Status last verified
Mar 2024
First submitted
5 Nov 2018
Last updated
22 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Sharing de-identified participant data stemming from focus groups, cognitive interviews, surveys, intervention arms, and post trial interviews.

Publications

  • 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.

    PubMed 31345981

Questions about this trial

What is this clinical trial studying?

A study testing Culture Specific in people with Colorectal Cancer, run by Medical College of Wisconsin.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Scale development (time frame: Year 1-2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03733197, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in