Choose It and Use It: Choice, Implementation Intentions and At-Home Colorectal Cancer Screening

Choice, Implementation Intentions and Colorectal Cancer 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:

• To what extent to individual prefer and select to complete screening with colonoscopy versus stool-based (FIT Kit or sDNA) options?
• Can full completion of (i.e. follow-through with) screening with a selected modality be enhanced by delivery of a culturally targeted intervention?

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Usual Care Message; Behavioral: Implementation Intention Intervention: Standard Message; Behavioral: Implementation Intention Intervention: Culturally-Targeted Message

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Flint, Michigan, United States, 48502
      • Michigan State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• African American, ages 45-72, Medicaid or Medicare or private insurance, current health center patient, eligible for CRC screening (Colonoscopy more than 10 years ago, Sigmoidoscopy more than 5 years ago, FOB test more than 1 year ago, FIT kit more than 1 year ago, sDNA test more than 3 years ago, Never been screened).

Exclusion Criteria:

• All who do not meet inclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care Message; Participants selecting a colorectal cancer screening will receive "usual care" from the FQHC.	Behavioral: Usual Care Message; Usual care is provided by the FQHC for the screening option chosen.
Active Comparator: Implementation Intention Intervention: Standard 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; Implementation Intention Intervention module includes standard messaging in addition to the usual care provided by the FQHC for the screening option chosen.
Experimental: Implementation Intention Intervention: Culturally-Targeted 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	collected immediately, up to 1 hour
Colorectal Cancer Screening Modality Request Rates	Frequency (percentage) with which colonoscopy versus FIT Kit versus sDNA kit versus no screening are selected.	up to 2 weeks
Colorectal Cancer Screening Completion Rate	Frequency (percentage of time) that chosen screening method is fully completed.	up to 6 months

Collaborators and Investigators

• Sponsor: Michigan State University
• Collaborators: American Cancer Society, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Colorectal Cancer; Colonoscopy; Health Disparities; Colorectal Cancer Screening; Health Communication; Cancer Screening; FIT Kit; sDNA Kit
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 00007344

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be made available per requirements and sharing structures established by the American Cancer Society.
• IPD Sharing Time Frame: Upon Study Completion
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No