Choose It and Use It

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Choice, Implementation Intentions and Colorectal Cancer Screening

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Behavioral: Usual Care Message
* Behavioral: Implementation Intention Intervention: Standard Message
* Behavioral: Implementation Intention Intervention: Culturally-Targeted Message


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care Message<br>Participants selecting a colorectal cancer screening will receive usual care from the FQHC. | Behavioral: Usual Care Message<br>* Usual care is provided by the FQHC for the screening option chosen.<br>|
| Active Comparator: Implementation Intention Intervention: Standard Message<br>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<br>* Implementation Intention Intervention module includes standard messaging in addition to the usual care provided by the FQHC for the screening option chosen.<br>|
| Experimental: Implementation Intention Intervention: Culturally-Targeted Message<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colorectal Cancer Screening Request | Does the participant request to participate in colorectal cancer screening? | up to 2 weeks | 
| Colorectal Cancer Screening Completion | Does the participant complete colorectal cancer screening after their request? | up to 6 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Cancer Screening, Colorectal Cancer, Colonoscopy, FIT Kit, sDNA Kit, Cancer Screening, Health Communication, Health Disparities