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Choose It and Use It

Primary Purpose

Colorectal Cancer

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual Care Message
Implementation Intention Intervention: Standard Message
Implementation Intention Intervention: Culturally-Targeted Message
Sponsored by
Michigan State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer focused on measuring Colorectal Cancer Screening, Colorectal Cancer, Colonoscopy, FIT Kit, sDNA Kit, Cancer Screening, Health Communication, Health Disparities

Eligibility Criteria

45 Years - 72 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Michigan State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Usual Care Message

Implementation Intention Intervention: Standard Message

Implementation Intention Intervention: Culturally-Targeted Message

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Colorectal Cancer Screening Request
Does the participant request to participate in colorectal cancer screening?
Colorectal Cancer Screening Completion
Does the participant complete colorectal cancer screening after their request?
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).
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).

Secondary Outcome Measures

Full Information

First Posted
October 10, 2023
Last Updated
October 10, 2023
Sponsor
Michigan State University
Collaborators
American Cancer Society, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06085560
Brief Title
Choose It and Use It
Official Title
Choice, Implementation Intentions and Colorectal Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 12, 2023 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University
Collaborators
American Cancer Society, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal Cancer Screening, Colorectal Cancer, Colonoscopy, FIT Kit, sDNA Kit, Cancer Screening, Health Communication, Health Disparities

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Participant
Masking Description
Participants will be unaware of their assignment to a general versus culturally targeted condition
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care Message
Arm Type
Active Comparator
Arm Description
Participants selecting a colorectal cancer screening will receive "usual care" from the FQHC.
Arm Title
Implementation Intention Intervention: Standard Message
Arm Type
Active Comparator
Arm Description
Participants selecting a colorectal cancer screening will receive implementation intention messages in addition to the "usual care" from the FQHC.
Arm Title
Implementation Intention Intervention: Culturally-Targeted Message
Arm Type
Experimental
Arm Description
Participants selecting a colorectal cancer screening will receive culturally-targeted implementation intention messages in addition to the "usual care" from the FQHC.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care Message
Intervention Description
Usual care is provided by the FQHC for the screening option chosen.
Intervention Type
Behavioral
Intervention Name(s)
Implementation Intention Intervention: Standard Message
Intervention Description
Implementation Intention Intervention module includes standard messaging in addition to the usual care provided by the FQHC for the screening option chosen.
Intervention Type
Behavioral
Intervention Name(s)
Implementation Intention Intervention: Culturally-Targeted Message
Intervention 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.
Primary Outcome Measure Information:
Title
Colorectal Cancer Screening Request
Description
Does the participant request to participate in colorectal cancer screening?
Time Frame
up to 2 weeks
Title
Colorectal Cancer Screening Completion
Description
Does the participant complete colorectal cancer screening after their request?
Time Frame
up to 6 weeks
Title
Theory of Planned Behavior Colorectal Cancer Screening Outcomes
Description
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).
Time Frame
collected immediately, up to 1 hour
Title
Anticipatory Racism
Description
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).
Time Frame
collected immediately, up to 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Michigan State University
City
Flint
State/Province
Michigan
ZIP/Postal Code
48502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be made available per requirements and sharing structures established by the American Cancer Society.
IPD Sharing Time Frame
Upon Study Completion

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