Choose It and Use It

Sponsor

Michigan State University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06085560

Collaborator

American Cancer Society, Inc. (Other)

600

Enrollment

Location

Arms

47.6

Anticipated Duration (Months)

12.6

Patients Per Site Per Month

Study Details

Study Description

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. They 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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Behavioral: Usual Care Message Behavioral: Implementation Intention Intervention: Standard Message Behavioral: Implementation Intention Intervention: Culturally-Targeted Message	N/A

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: We propose to evaluate preference for and conversion rates associated with colonoscopy, FIT Kit and sDNA testing among low income Africans Americans, and we 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, we 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 - we 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, we will also evaluate a culturally-targeted approach to implementation intentions for use with CRC screening.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Design is partial factorial. After watching a series of general education videos, if participants choose to participate in a colorectal cancer screening option, they are assigned an intervention within the screening they chose. Within each screening option, one third of participants will receive usual care messaging, one third of participants will receive implementation intention intervention messaging, and one third of participants will receive culturally-targeted implementation intention intervention messaging.Design is partial factorial. After watching a series of general education videos, if participants choose to participate in a colorectal cancer screening option, they are assigned an intervention within the screening they chose. Within each screening option, one third of participants will receive usual care messaging, one third of participants will receive implementation intention intervention messaging, and one third of participants will receive culturally-targeted implementation intention intervention messaging.

Masking:

Single (Participant)

Masking Description:

Participants will be unaware of their assignment to a general versus culturally targeted condition

Primary Purpose:

Screening

Official Title:

Choice, Implementation Intentions and Colorectal Cancer Screening

Actual Study Start Date :

Jul 12, 2023

Anticipated Primary Completion Date :

Jun 30, 2026

Anticipated Study Completion Date :

Jun 30, 2027

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Colorectal Cancer Screening Request [up to 2 weeks]
Does the participant request to participate in colorectal cancer screening?
Colorectal Cancer Screening Completion [up to 6 weeks]
Does the participant complete colorectal cancer screening after their request?
Theory of Planned Behavior Colorectal Cancer Screening Outcomes [collected immediately, up to 1 hour]
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).
Anticipatory Racism [collected immediately, up to 1 hour]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 72 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).