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Completed

NCT Number: NCT03640208

Educate, Assess Risk and Overcoming Barriers to Colorectal Screening Among 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

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44122, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Acceptability of intervention

    Time frame: At the end of education - 24 weeks

    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.

  2. Feasibility of Intervention

    Time frame: At the end of education - 24 weeks

    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.

  3. Fidelity of intervention

    Time frame: At the end of education - 24 weeks

    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.

  4. 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 individuals aged 45-75 who have never had colon or rectal cancer screening

  5. Percentage of participants who found the Risk assessment questionnaire helpful

    Time frame: At the end of education - 24 weeks

    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.

  6. Barriers faced to scheduling colorectal cancer screening

    Time frame: At the end of education - 24 weeks

    Percent of participants with barriers to receiving colorectal cancer screening.

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Aug 21, 2018
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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