Colorectal CancerNCT03640208
Educate, Assess Risk and Overcoming Barriers to Colorectal Screening Among African Americans
A study testing Education presented by trained caregiver in people with Colorectal Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The burden of colorectal cancer (CRC) is unequal among various populations within the United States. This inequality is most notable among African Americans, who exhibit the highest CRC mortality of all US populations. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Education presented by trained caregiver
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2019to 3 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Education Only: African American individuals 18 years and older.
- CRC colonoscopy screening : Average Risk African American individuals ages 45 - 75 who did not have a screening colonoscopy or other screening modality within the past10 years, have no history of CRC, adenomatous polyps or Inflammatory Bowel Disease (IBD) and no family history of colorectal cancer. This will be identified during outreach events (steps 3 and 4).
- It is important to note that this program may ultimately include all races as a community outreach event, however we will not analyze the data of non-African Americans.
Who cannot join
- African American individuals under the age of 18
- Colonoscopy within 10 years
- History of CRC, Adenoma, IBD
- Family history of CRC
- Fecal immunochemical test (FIT) within the past year
- Cologuard test within the past 3 years
- Flexible Sigmoidoscopy test within the past 5 years
- Colonography within the past 5 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, 44122
About this study
Official title: Evaluating the Effectiveness of A Proposed 11-Step Community-Based Interventional Program That Educates, Assesses Risk And Overcomes Barriers to Complete Screening Colonoscopy Among Average Risk African Americans
The burden of colorectal cancer (CRC) is unequal among various populations within the United States. This inequality is most notable among African Americans, who exhibit the highest CRC mortality of all US populations. This study aims to evaluate a community-based intervention to educate, assess risk, and overcome barriers to screening among African Americans who are 45 years or older with no personal history of CRC, adenomas, or inflammatory bowel disease and have no family history of CRC.
Barriers being assessed include: Need for establishing care with primary care physician, need for financial assistance, need for reminder calls, need for transportation, need for appointment coordination, and need for education about colonoscopy preparation and procedure
Read the detailed description
After reviewing the existing literature this study team believes that the proposed strategy is inherently unique, thus amenable to experimental inquiry.
The study will provide much needed data to define the extent to which the proposed multi-faceted approach may be effectively deployed to the target population. This includes the acquisition of data to evaluate the educational program, for which improvement in knowledge may be tested objectively using the study design, as well as survey and feasibility data which is pivotal for improving the strategy.
The 11 steps for completing cancer screening are listed below:
- Demographic/Socio-economic information
- Knowledge assessment and education
- Risk assessment questionnaire "Am I Average Risk?"
- Do I need screening colonoscopy?
- Barriers to colorectal cancer screening
- Outreach program evaluation
- Participants data entered in REDCap database
- Communication with primary care provider and navigator
- Participant navigation
- Evaluation of navigation services
- Program monitoring
- Conditions
- Colorectal Cancer
- Being tested
- Education presented by trained caregiver
- Keywords
- health disparities, African American, risk assessment, secondary prevention
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education presented by trained caregiverBehavioural
After participants complete the Pre-test, an educational session will be presented by a trained caregiver, delivered in a lecture-style manner with Power Point projection of educational material. The slides in this presentation will be scripted to mitigate variability among different presenters. Topics addressed in the presentation include: CRC basics (including brief anatomy), data on disparity, risk factors, screening modalities, preventative measures, population disparities of CRC, colonoscopy exam and other screening tests. The emphasis will be on CRC risks factors and prevention. All required information that is needed to correctly answer post-test questions is embedded within the presentation.
| Study group | Role | What they receive |
|---|---|---|
| Complete colorectal screening | Experimental | 11 step process divided into three phases: 1. Community Outreach Event; 2. Data Collection; 3. Navigation and Program Monitoring Receives: Behavioral: Education presented by trained caregiver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in paired pre-/post-test score
16 item knowledge questions, where each item is assessed as true, false, or not sure. A 25% improvement of knowledge between pre- and post-test scores will indicate an effective program
Measured: From baseline (week 0) to follow-up end of study (week 24)
Secondary outcomes (6)
Acceptability of intervention
Metrics (convenient, appropriate, effective, satisfaction) will be measured on a 5-point scale where the two most favorable categories (i.e. strongly agree and agree) will be considered a positive response.
Measured: At the end of education - 24 weeks
Feasibility of Intervention
Measured by evaluating practicality or logistics of the proposed interventional program with 8 item dichotomous questionnaire.
A 100% positive response on the questionnaire (all 8 items answered 'yes') will be considered a 'positive' questionnaire for an individual participant. If 80% of participants respond with an overall 'positive' questionnaire, the study will be considered feasible.
Measured: At the end of education - 24 weeks
Fidelity of intervention
Number of documented deviations throughout the program.
90% of the 11-step program needs to be followed. A 'deviation' would be defined as not adhering to one of the 11 steps.
Measured: At the end of education - 24 weeks
Percentage of individuals aged 45-75 who have never had colon or rectal cancer screening
Percentage of individuals aged 45-75 who have never had colon or rectal cancer screening
Measured: At the end of education - 24 weeks
Percentage of participants who found the Risk assessment questionnaire helpful
Metrics will be measured on a 5-point scale where the two most favorable categories (i.e. strongly agree and agree) will be considered a positive response.
Measured: At the end of education - 24 weeks
Barriers faced to scheduling colorectal cancer screening
Percent of participants with barriers to receiving colorectal cancer screening.
Measured: At the end of education - 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start27 Feb 2019
- Primary completion3 Nov 2024
- Study completion3 Nov 2024
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.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samir Abraksia, MD, Principal investigator, Cleveland Clinic, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640208
- Sponsor's protocol ID
- CASE10217
- Status last verified
- Feb 2026
- First submitted
- 14 Aug 2018
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of A Proposed 11-Step Community-Based Interventional Program That Educates, Assesses Risk And Overcomes Barriers to Complete Screening Colonoscopy Among Average Risk African Americans
- ClinicalTrials.gov ID
- NCT03640208
- Acronym / sponsor ID
- CASE10217
- Conditions
- Colorectal Cancer
- Keywords
- health disparities, African American, risk assessment, secondary prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 3 Nov 2024 (actual)
- Study completion
- 3 Nov 2024 (actual)
- First posted
- 21 Aug 2018 (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 burden of colorectal cancer (CRC) is unequal among various populations within the United States. This inequality is most notable among African Americans, who exhibit the highest CRC mortality of all US populations. This study aims to evaluate a community-based intervention to educate, assess risk, and overcome barriers to screening among African Americans who are 45 years or older with no personal history of CRC, adenomas, or inflammatory bowel disease and have no family history of CRC.
Barriers being assessed include: Need for establishing care with primary care physician, need for financial assistance, need for reminder calls, need for transportation, need for appointment coordination, and need for education about colonoscopy preparation and procedure
Detailed description
After reviewing the existing literature this study team believes that the proposed strategy is inherently unique, thus amenable to experimental inquiry.
The study will provide much needed data to define the extent to which the proposed multi-faceted approach may be effectively deployed to the target population. This includes the acquisition of data to evaluate the educational program, for which improvement in knowledge may be tested objectively using the study design, as well as survey and feasibility data which is pivotal for improving the strategy.
The 11 steps for completing cancer screening are listed below:
- Demographic/Socio-economic information
- Knowledge assessment and education
- Risk assessment questionnaire "Am I Average Risk?"
- Do I need screening colonoscopy?
- Barriers to colorectal cancer screening
- Outreach program evaluation
- Participants data entered in REDCap database
- Communication with primary care provider and navigator
- Participant navigation
- Evaluation of navigation services
- Program monitoring
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Complete colorectal screening | Experimental | Behavioral: Education presented by trained caregiver11 step process divided into three phases: 1. Community Outreach Event; 2. Data Collection; 3. Navigation and Program Monitoring |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Education Only: African American individuals 18 years and older.
- CRC colonoscopy screening : Average Risk African American individuals ages 45 - 75 who did not have a screening colonoscopy or other screening modality within the past10 years, have no history of CRC, adenomatous polyps or Inflammatory Bowel Disease (IBD) and no family history of colorectal cancer. This will be identified during outreach events (steps 3 and 4).
- It is important to note that this program may ultimately include all races as a community outreach event, however we will not analyze the data of non-African Americans.
Key exclusion criteria (8 listed)
- African American individuals under the age of 18
- Colonoscopy within 10 years
- History of CRC, Adenoma, IBD
- Family history of CRC
- Fecal immunochemical test (FIT) within the past year
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 |
|---|---|---|
| Education presented by trained caregiverAfter participants complete the Pre-test, an educational session will be presented by a trained caregiver, delivered in a lecture-style manner with Power Point projection of educational material. The slides in this presentation will be scripted to mitigate variability among different presenters. Topics addressed in the presentation include: CRC basics (including brief anatomy), data on disparity, risk factors, screening modalities, preventative measures, population disparities of CRC, colonoscopy exam and other screening tests. The emphasis will be on CRC risks factors and prevention. All required information that is needed to correctly answer post-test questions is embedded within the presentation. | Behavioural | Complete colorectal screening |
Primary outcome
Difference in paired pre-/post-test score
Time frame: From baseline (week 0) to follow-up end of study (week 24)
16 item knowledge questions, where each item is assessed as true, false, or not sure. A 25% improvement of knowledge between pre- and post-test scores will indicate an effective program
6 secondary outcomes
Acceptability of intervention
Time frame: At the end of education - 24 weeks
Feasibility of Intervention
Time frame: At the end of education - 24 weeks
Fidelity of intervention
Time frame: At the end of education - 24 weeks
Percentage of individuals aged 45-75 who have never had colon or rectal cancer screening
Time frame: At the end of education - 24 weeks
Percentage of participants who found the Risk assessment questionnaire helpful
Time frame: At the end of education - 24 weeks
Barriers faced to scheduling colorectal cancer screening
Time frame: At the end of education - 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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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. This study is not recruiting at the moment.
Samir Abraksia, MD principal investigator
Cleveland Clinic, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education presented by trained caregiver in people with Colorectal Cancer, run by Case Comprehensive Cancer Center 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 27 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in paired pre-/post-test score (time frame: From baseline (week 0) to follow-up end of study (week 24)). 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 27 Feb 2026.