Colorectal CancerNCT06085560
Choose It and Use It: Choice, Implementation Intentions and At-Home Colorectal Cancer Screening
A study testing Implementation Intention Intervention: Standard Message and Implementation Intention Intervention: Culturally-Targeted Message in people with Colorectal Cancer, run by Michigan State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Implementation Intention Intervention: Standard Message and Implementation Intention Intervention: Culturally-Targeted Message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African American, ages 45-72, Medicaid or Medicare or private insurance, current health center patient, 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).
Who cannot join
- All who do not meet inclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Choice, Implementation Intentions and Colorectal Cancer Screening
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Usual Care Message, Implementation Intention Intervention: Standard Message, Implementation Intention Intervention: Culturally-Targeted Message
- Keywords
- Colorectal Cancer Screening, Colorectal Cancer, Colonoscopy, FIT Kit, sDNA Kit, Cancer Screening, Health Communication, Health Disparities
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Care MessageBehavioural
Usual care is provided by the FQHC for the screening option chosen.
Implementation Intention Intervention: Standard MessageBehavioural
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: Culturally-Targeted MessageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Message | Active comparator | Participants selecting a colorectal cancer screening will receive "usual care" from the FQHC. Receives: 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. Receives: 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. Receives: Behavioral: Implementation Intention Intervention: Culturally-Targeted Message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal Cancer Screening Modality Request Rates
Frequency (percentage) with which colonoscopy versus FIT Kit versus sDNA kit versus no screening are selected.
Measured: up to 2 weeks
Colorectal Cancer Screening Completion Rate
Frequency (percentage of time) that chosen screening method is fully completed.
Measured: 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).
Measured: 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).
Measured: collected immediately, up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start12 Jul 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Todd Lucas, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085560
- Sponsor's protocol ID
- 00007344
- Status last verified
- May 2026
- First submitted
- 10 Oct 2023
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available per requirements and sharing structures established by the American Cancer Society.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choice, Implementation Intentions and Colorectal Cancer Screening
- ClinicalTrials.gov ID
- NCT06085560
- Acronym / sponsor ID
- 00007344
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer Screening, Colorectal Cancer, Colonoscopy, FIT Kit, sDNA Kit, Cancer Screening, Health Communication, Health Disparities
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual Care Message | Active comparator | Behavioral: Usual Care MessageParticipants selecting a colorectal cancer screening will receive "usual care" from the FQHC. |
| Implementation Intention Intervention: Standard Message | Active comparator | Behavioral: Implementation Intention Intervention: Standard MessageParticipants selecting a colorectal cancer screening will receive implementation intention messages in addition to the "usual care" from the FQHC. |
| Implementation Intention Intervention: Culturally-Targeted Message | Experimental | Behavioral: Implementation Intention Intervention: Culturally-Targeted MessageParticipants selecting a colorectal cancer screening will receive culturally-targeted implementation intention messages in addition to the "usual care" from the FQHC. |
Who may qualify
- Ages
- 45 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- African American, ages 45-72, Medicaid or Medicare or private insurance, current health center patient, 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).
Key exclusion criteria (1 listed)
- All who do not meet inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual Care MessageUsual care is provided by the FQHC for the screening option chosen. | Behavioural | Usual Care Message |
| Implementation Intention Intervention: Standard MessageImplementation Intention Intervention module includes standard messaging in addition to the usual care provided by the FQHC for the screening option chosen. | Behavioural | Implementation Intention Intervention: Standard Message |
| Implementation Intention Intervention: Culturally-Targeted MessageImplementation 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. | Behavioural | Implementation Intention Intervention: Culturally-Targeted Message |
Primary outcome
Colorectal Cancer Screening Modality Request Rates
Time frame: up to 2 weeks
Frequency (percentage) with which colonoscopy versus FIT Kit versus sDNA kit versus no screening are selected.
Colorectal Cancer Screening Completion Rate
Time frame: up to 6 months
Frequency (percentage of time) that chosen screening method is fully completed.
Theory of Planned Behavior Colorectal Cancer Screening Outcomes
Time frame: 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
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Yes. Data will be made available per requirements and sharing structures established by the American Cancer Society.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation Intention Intervention: Standard Message and Implementation Intention Intervention: Culturally-Targeted Message in people with Colorectal Cancer, run by Michigan State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colorectal Cancer Screening Modality Request Rates (time frame: up to 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.