Colorectal Cancer Screening Intervention Study

Colorectal Cancer Clinical Trial

Official title:

Colorectal Screening Fear-reduction and Racially-targeted Norm Messaging Entreaties to Increase Colorectal Cancer Screening Rates Among African Americans

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06424197
• Other study ID #: IRB-FY2023-3
• Secondary ID: R21MD016506
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: June 2024
• Source: Oakland University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 799
• Est. completion date: August 31, 2024
• Est. primary completion date: April 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Not meeting inclusion criteria

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Racial group-targeted messages
Colorectal cancer screening messages targeted towards participants racial group.
• Explicit Commitment
Indicate explicit commitment to return at home screening kit.

Locations

Country	Name	City	State
United States	Oakland University	Rochester	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Oakland University	National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FIT Kit request	FIT Kit request	Immediately after survey
Secondary	FIT Kit return	Mailing completed FIT Kit to lab for processing	3 months