Educate, Assess Risk and Overcoming Barriers to Colorectal Screening Among African Americans

NCT03640208 | Completed

• 1 other identifier: CASE10217
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Colorectal Cancer

Keywords

health disparities; African American; risk assessment; secondary prevention

Outcome Measures

Primary Outcomes (1)

• 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

  From baseline (week 0) to follow-up end of study (week 24)

Secondary Outcomes (6)

• Acceptability of intervention

  At the end of education - 24 weeks

• Feasibility of Intervention

  At the end of education - 24 weeks

• Fidelity of intervention

  At the end of education - 24 weeks

• Percentage of individuals aged 45-75 who have never had colon or rectal cancer screening

  At the end of education - 24 weeks

• Percentage of participants who found the Risk assessment questionnaire helpful

  At the end of education - 24 weeks

Study Arms (1)

Complete colorectal screening

EXPERIMENTAL

11 step process divided into three phases: 1. Community Outreach Event; 2. Data Collection; 3. Navigation and Program Monitoring

Behavioral: Education presented by trained caregiver

Interventions

Education presented by trained caregiver BEHAVIORAL

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.

Complete colorectal screening

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44122, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Samir Abraksia, MD

  Cleveland Clinic, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 21, 2018
• Study Start: February 27, 2019
• Primary Completion: November 3, 2024
• Study Completion: November 3, 2024
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)