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

NCT06085560 | Enrolling By Invitation DMC

• 1 other identifier: 00007344
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Colorectal Cancer Screening; Colorectal Cancer; Colonoscopy; FIT Kit; sDNA Kit; Cancer Screening; Health Communication; Health Disparities

Outcome Measures

Primary Outcomes (4)

• 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

• 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

Study Arms (3)

Usual Care Message

ACTIVE COMPARATOR

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

Behavioral: Usual Care Message

Implementation Intention Intervention: Standard Message

ACTIVE COMPARATOR

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: Culturally-Targeted Message

EXPERIMENTAL

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

Interventions

Usual Care Message BEHAVIORAL

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

Usual Care Message

Implementation Intention Intervention: Standard Message 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: Standard Message

Implementation Intention Intervention: Culturally-Targeted Message 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.

Implementation Intention Intervention: Culturally-Targeted Message

Eligibility Criteria

• Age: 45 Years - 72 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• Michigan State University: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Michigan State University

Flint, Michigan, 48502, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be unaware of their assignment to usual care vs. intervention conditions
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: C.S. Mott Endowed Professor

Model Details: Design is factorial. After watching a brief didactic video, participants who opt to partake in colorectal cancer screening self select one of three screening modalities (colonoscopy vs. FIT Kit vs. sDNA Kit). Participants are then randomly assigned to one of three study arms (usual care vs. implementation intentions intervention vs. culturally targeted implementation intentions intervention). Screening selection and study arms are fully crossed.

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 17, 2023
• Study Start: July 12, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Upon Study Completion

Locations

US (1)