Colorectal Cancer Screening Intervention Study

NCT ID: NCT06424197

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 799 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-08-31

Brief 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.

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Norm Based Messages

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

Group Type: EXPERIMENTAL

Racial group-targeted messages

Intervention Type: OTHER

Colorectal cancer screening messages targeted towards participants racial group.

Fear Reduction Message

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

Group Type: EXPERIMENTAL

Racial group-targeted messages

Intervention Type: OTHER

Colorectal cancer screening messages targeted towards participants racial group.

Commitment

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

Group Type: EXPERIMENTAL

Explicit Commitment

Intervention Type: OTHER

Indicate explicit commitment to return at home screening kit.

Control

Participants receive no health messages.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Racial group-targeted messages

Colorectal cancer screening messages targeted towards participants racial group.

Intervention Type: OTHER

Explicit Commitment

Indicate explicit commitment to return at home screening kit.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Oakland University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Manning, PhD

Role: PRINCIPAL_INVESTIGATOR

Oakland University

Locations

Oakland University

Rochester, Michigan, United States

Countries

United States

Other Identifiers

R21MD016506

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-FY2023-3

Identifier Type: -

Identifier Source: org_study_id