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CompletedNCT06424197Updated Aug 8, 2025

Colorectal Cancer Screening Intervention Study

An interventional study of Racial group-targeted messages and Explicit Commitment in Colorectal Cancer, sponsored by Oakland University. Completed at 1 site in United States. Open to participants aged 45 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-08.

Sponsored by Oakland University · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Mar 2023, registered May 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
799
Allocation
Randomized
Ages
45 Years to 80 Years
Sex
All
01

Study summary

Colorectal cancer (CRC) is one of the leading causes of cancer mortality in the United States, and African Americans (AfAms) still fare worse in CRC incidence and mortality compared to European Americans (EuAms). We propose to examine whether combining both fear-reduction and racially-targeted norm-based messages will increase at-home stool-based CRC screening receptivity and uptake for all African American regardless of level of racial identity. Given low return rates of at-home screening kits, we will also explore whether making an explicit commitment to return screening kits is associated with increased kit returns.

Read the detailed description

Colorectal cancer (CRC) is one of the leading causes of cancer mortality in the United States, and African Americans (AfAms) still fare worse in CRC incidence and mortality compared to European Americans (EuAms).Interventions to increase CRC screening rates among AfAms are instrumental to address the disparities in CRC incidence and mortality. Despite literature indicating that AfAms' fears (e.g., of colonoscopy procedures or cancer diagnosis) serve as barriers to CRC screening, no interventions have used theory-guided methods to directly target fear-based beliefs. Additionally, no research has examined the extent to which racial identity moderates the effects of racially targeted messaging, despite the ubiquity of using targeted health messaging entreaties among minority groups. This is particularly relevant given our work showing that racially-targeted screening entreaties increased CRC screening intentions among AfAms who identified less strongly, but depressed those intentions among AfAms who identified more strongly with their racial group. Lack of focus on other salient CRC screening barriers may have been off-putting to highly identified African Americans. We propose to examine whether combining both fear-reduction and racially-targeted norm-based messages will increase at-home stool-based CRC screening receptivity and uptake for all African American regardless of level of racial identity. Given low return rates of at-home screening kits, we will also explore whether making an explicit commitment to return screening kits is associated with increased kit returns.

Aim 1: To develop and refine a fear-reduction intervention guided by the theory of planned behavior and by published literature, in conjunction with AfAm community experts.

Aim 2: To examine whether the fear-reduction entreaty increases receptivity to, and uptake of at-home CRC screening when coupled with racially-targeted norm-based messages.

Aim 3: To examine the moderating roles of racial identity and perceived CRC risk on the effects of fear-reduction and racially-targeted norm-based messaging entreaties.

Aim 4: We will explore whether participants who make explicit commitments to return FIT Kits return them at a higher rate compared to those who do not make such commitments.

02

Conditions studied

  • Colorectal Cancer

Keywords

  • Colorectcal Cancer Screening Targeted Message Intervention
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 799 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Oakland University is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

African American Overdue to colorectal cancer screening Has primary care physician Not at high risk for colorectal cancer

Exclusion criteria

Exclusion Criteria:

Not meeting inclusion criteria

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
799 participants (actual)

Study arms

  • Experimental
    Norm Based Messages

    One of 3 messaging entreaties based on normative perceptions of colorectal cancer screening, and one no norm-based messaging arm.

    Other: Racial group-targeted messages

  • Experimental
    Fear Reduction Message

    Participants randomized to receive (or not receive) messaging entreaty to address colorectal cancer screening fears.

    Other: Racial group-targeted messages

  • Experimental
    Commitment

    Participants randomized to indicate explicit commitment to return FIT Kits for processing.

    Other: Explicit Commitment

  • No intervention
    Control

    Participants receive no health messages.

Interventions

  • OtherRacial group-targeted messages

    Colorectal cancer screening messages targeted towards participants racial group.

  • OtherExplicit Commitment

    Indicate explicit commitment to return at home screening kit.

06

What researchers measure

Primary outcomes

  1. FIT Kit request

    FIT Kit request

    Time frame: Immediately after survey

Secondary outcomes

  1. FIT Kit return

    Mailing completed FIT Kit to lab for processing

    Time frame: 3 months

07

Study locations

1 site
  • Oakland University
    Rochester, Michigan 48309, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06424197
Lead sponsor
Oakland University
Collaborators
National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
Responsible party
Sponsor
First posted
May 22, 2024
Start date
Mar 1, 2023
Primary completion
Apr 23, 2024
Completion
Aug 31, 2024
Last update
Aug 8, 2025

Study contacts

Mark Manning, PhD
principal investigator · Oakland University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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