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

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

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Education presented by trained caregiver

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:

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

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samir Abraksia, MD; Phone Number: 1-866-223-8100; Email: TaussigResearch@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44122
      • Recruiting
      • Cleveland Clinic, Case Comprehensive Cancer Center
      • Contact: Samir Abraksia, MD; Phone Number: 866-223-8100; Email: TaussigResearch@ccf.org
      • Principal Investigator: Samir Abraksia, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Complete colorectal screening; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	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.	At the end of education - 24 weeks
Barriers faced to scheduling colorectal cancer screening	Percent of participants with barriers to receiving colorectal cancer screening.	At the end of education - 24 weeks

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Samir Abraksia, MD, Cleveland Clinic, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2019
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: August 14, 2018
• First Submitted That Met QC Criteria: August 17, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: African American; risk assessment; secondary prevention; health disparities
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CASE10217

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No