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

NCT ID: NCT06085560

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-12
• Study Completion Date: 2027-06-30

Brief Summary

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.

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.

Conditions

Colorectal Cancer

Study Design

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

Study Groups

Usual Care Message

Participants selecting a colorectal cancer screening will receive "usual care" from the FQHC.

Group Type: ACTIVE_COMPARATOR

Usual Care Message

Intervention Type: BEHAVIORAL

Usual care is provided by the FQHC for the screening option chosen.

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.

Group Type: ACTIVE_COMPARATOR

Implementation Intention Intervention: Standard Message

Intervention Type: BEHAVIORAL

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: 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.

Group Type: EXPERIMENTAL

Implementation Intention Intervention: Culturally-Targeted Message

Intervention Type: BEHAVIORAL

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.

Interventions

Usual Care Message

Usual care is provided by the FQHC for the screening option chosen.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• African American, ages 45-72, Medicaid or Medicare insurance, enrolled in a FQHC, 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).

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Cancer Society, Inc.

OTHER

Sponsor Role: collaborator

Michigan State University

OTHER

Sponsor Role: lead

Responsible Party

Todd Lucas

C.S. Mott Endowed Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Michigan State University

Flint, Michigan, United States

Countries

United States

Other Identifiers

00007344

Identifier Type: -

Identifier Source: org_study_id