Clinical trial NCT06424197: Colorectal Cancer Screening Intervention Study
Official title: Colorectal Screening Fear-reduction and Racially-targeted Norm Messaging Entreaties to Increase Colorectal Cancer Screening Rates Among African Americans
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectcal Cancer Screening Targeted Message Intervention
Lead sponsor: Oakland University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-05-22
Enrollment: 799
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: FIT Kit request
timeFrame: Immediately after survey
Secondary outcomes:
measure: FIT Kit return
timeFrame: 3 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Oakland University
state: Michigan
Study officials:
affiliation: Oakland University
name: Mark Manning, PhD
role: PRINCIPAL_INVESTIGATOR
References: