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

Michigan State University

Status: Invitation-only

Conditions: Colorectal Cancer

Treatments: Behavioral: Usual Care Message; Behavioral: Implementation Intention Intervention: Standard Message; Behavioral: Implementation Intention Intervention: Culturally-Targeted Message

Study type: Interventional

Funder types: Other

Identifiers

NCT06085560

00007344

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 45 to 72 years old

Volunteers: Accepts Healthy Volunteers

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).

Exclusion criteria

• All who do not meet inclusion criteria.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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600 participants in 3 patient groups

Usual Care Message

Active Comparator group

Description:

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

Treatment:

Behavioral: Usual Care Message

Implementation Intention Intervention: Standard Message

Active Comparator group

Description:

Participants selecting a colorectal cancer screening will receive implementation intention messages in addition to the "usual care" from the FQHC.

Treatment:

Behavioral: Implementation Intention Intervention: Standard Message

Implementation Intention Intervention: Culturally-Targeted Message

Experimental group

Description:

Participants selecting a colorectal cancer screening will receive culturally-targeted implementation intention messages in addition to the "usual care" from the FQHC.

Treatment:

Behavioral: Implementation Intention Intervention: Culturally-Targeted Message