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

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

NCT ID: NCT06085560

Condition: Colorectal Cancer

Conditions: Official terms:
Colorectal Neoplasms

Conditions: Keywords:
Colorectal Cancer Screening
Colorectal Cancer
Colonoscopy
FIT Kit
sDNA Kit
Cancer Screening
Health Communication
Health Disparities

Study type: Interventional

Study phase: N/A

Overall status: Enrolling by invitation

Study design:

Allocation: Randomized

Intervention model: Factorial Assignment

Intervention model description: 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.

Primary purpose: Screening

Masking: Single (Participant)

Masking description: Participants will be unaware of their assignment to usual care vs. intervention conditions

Intervention:

Intervention type: Behavioral
Intervention name: Usual Care Message
Description: Usual care is provided by the FQHC for the screening option chosen.
Arm group label: Usual Care Message

Intervention type: Behavioral
Intervention name: Implementation Intention Intervention: Standard Message
Description: Implementation Intention Intervention module includes standard messaging in addition to the usual care provided by the FQHC for the screening option chosen.
Arm group label: Implementation Intention Intervention: Standard Message

Intervention type: Behavioral
Intervention name: Implementation Intention Intervention: Culturally-Targeted Message
Description: 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.
Arm group label: Implementation Intention Intervention: Culturally-Targeted Message

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.

Criteria for 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). Exclusion Criteria: - All who do not meet inclusion criteria.

Gender: All

Minimum age: 45 Years

Maximum age: 72 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Michigan State University

Address:
City: Flint
Zip: 48502
Country: United States

Start date: July 12, 2023

Completion date: June 30, 2027

Lead sponsor:
Agency: Michigan State University
Agency class: Other

Collaborator:
Agency: American Cancer Society, Inc.
Agency class: Other

Source: Michigan State University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06085560