Educate, Assess Risk and Overcoming Barriers to Colorectal Screening Among African Americans
NCT ID: NCT03640208
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
163 participants
INTERVENTIONAL
2019-02-27
2024-11-03
Brief Summary
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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
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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:
1. Demographic/Socio-economic information
2. Knowledge assessment and education
3. Risk assessment questionnaire "Am I Average Risk?"
4. Do I need screening colonoscopy?
5. Barriers to colorectal cancer screening
6. Outreach program evaluation
7. Participants data entered in REDCap database
8. Communication with primary care provider and navigator
9. Participant navigation
10. Evaluation of navigation services
11. Program monitoring
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Complete colorectal screening
11 step process divided into three phases: 1. Community Outreach Event; 2. Data Collection; 3. Navigation and Program Monitoring
Education presented by trained caregiver
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.
Interventions
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Education presented by trained caregiver
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
45 Years
ALL
Yes
Sponsors
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Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Samir Abraksia, MD
Role: PRINCIPAL_INVESTIGATOR
Cleveland Clinic, Case Comprehensive Cancer Center
Locations
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Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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CASE10217
Identifier Type: -
Identifier Source: org_study_id