An interventional study of Usual Care Message and Implementation Intention Intervention: Standard Message in Colorectal Cancer, sponsored by Michigan State University. Enrolling by invitation at 1 site in United States. Open to participants aged 45 Years to 72 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Michigan State University · Not applicable, Interventional, and Screening
The goal of this study is to improve use of colorectal cancer screening among screening eligible African Americans who are served by Federally Qualified Health Centers in Michigan. The main questions it aims to answer are:
Participants will learn about colonoscopy, FIT Kit and sDNA as recommended and widely used screening options. Participants will select a modality to complete their own screening with. Participants will then be randomized to one of three arms (usual care, standard intervention, culturally targeted intervention). Researchers will compare the extent to which intervention arms enhance completion rates across each of the three screening modalities.
Background: African-Americans are more likely than other racial groups to develop and die from colorectal cancer (CRC). These disparities are largely due to lower rates of CRC detection among African-Americans. At-home CRC screening using a recommended screening tool - including fecal immunochemical testing (FIT Kit) and stool DNA testing (sDNA) ¬- could aid in reducing disparities. Yet, at-home screening remains underutilized, and little is known about preferences for specific at-home screening alternatives, despite that options present tradeoffs that likely influence uptake. Another challenge, including among African Americans, is that at-home screening suffers from low conversion - full completion of screening by individuals who are issued at-home screening kits. Implementation intentions may be an effective psychological tool for overcoming low conversion among African Americans.
Objective/Hypothesis: This study proposes to evaluate preference for and conversion rates associated with colonoscopy, FIT Kit and sDNA testing among low income Africans Americans, and will evaluate use of implementation intentions to promote uptake and conversion across these screening modalities.
Specific Aims: (1) To identify and compare preferences for colonoscopy versus annual FIT KIT testing versus stool DNA testing once every three years in a community sample of CRC screening-eligible African-Americans; (2) To identify and compare conversion of at-home CRC screening over three years among participants who elect to complete FIT Kit versus stool DNA testing for at-home CRC screening; (3) To determine the effectiveness of utilizing culturally targeted Implementation Intentions to promote conversion of colonoscopy and at-home CRC screening in screening eligible African-Americans.
Study design: In collaboration with clinical and community experts, the investigators will develop video materials to educate CRC screening eligible individuals about colonoscopy FIT Kit and sDNA as options for at-home CRC screening. In partnership with two Federally Qualified Health Center - one in Detroit, MI and one in Flint, MI - the investigators will provide access to these screening options and evaluate preferences for and conversion associated with each screening modality in a sample of screening eligible low-income African Americans. To consider strategies for enhancing conversion, the investigators will also evaluate a culturally-targeted approach to implementation intentions for use with CRC screening.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 600 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Michigan State University is the lead sponsor of 139 studies on the registry; 26 are open to participants now.
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Exclusion Criteria:
Participants selecting a colorectal cancer screening will receive "usual care" from the FQHC.
Behavioral: Usual Care Message
Participants selecting a colorectal cancer screening will receive implementation intention messages in addition to the "usual care" from the FQHC.
Behavioral: Implementation Intention Intervention: Standard Message
Participants selecting a colorectal cancer screening will receive culturally-targeted implementation intention messages in addition to the "usual care" from the FQHC.
Behavioral: Implementation Intention Intervention: Culturally-Targeted Message
Usual care is provided by the FQHC for the screening option chosen.
Implementation Intention Intervention module includes standard messaging in addition to the usual care provided by the FQHC for the screening option chosen.
Implementation Intention Intervention module includes culturally-targeted framing of health information messages in addition to the usual care provided by the FQHC for the screening option chosen.
Colorectal Cancer Screening Modality Request Rates
Frequency (percentage) with which colonoscopy versus FIT Kit versus sDNA kit versus no screening are selected.
Time frame: up to 2 weeks
Colorectal Cancer Screening Completion Rate
Frequency (percentage of time) that chosen screening method is fully completed.
Time frame: up to 6 months
Theory of Planned Behavior Colorectal Cancer Screening Outcomes
Self-report measures of colorectal cancer screening attitudes, norms, perceived control, intentions to be screened are each adapted from published research (Lucas et al., 2021). These items are constructed following recommended procedures to ensure construct validity and adequate behavioral specificity (Fishbein \& Ajzen, 2011). All items use Likert-type scales that range from 1 (strongly agree) to 7 (strongly disagree).
Time frame: collected immediately, up to 1 hour
Anticipatory Racism
Adapted from published research (Lucas et al., 2021), all participants respond to questions that asked whether they believe racism would impact the benefits they could experience from obtaining colorectal cancer screening. Participants will then respond to three questions that ask, "In some way, my obtaining CRC screening would be impacted by racism," "Racism would undermine the value of CRC screening for me." and "Racism would negatively impact the accuracy of my CRC screening. Responses are collected using a 7-point Likert-type scale that ranged from 1 (strongly agree) to 7 (strongly disagree).
Time frame: collected immediately, up to 1 hour
Plan to share: Yes — Data will be made available per requirements and sharing structures established by the American Cancer Society.
Supporting information: Study protocol
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