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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03640208
• Other study ID #: CASE10217
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2019
• Est. completion date: September 1, 2024

Study information

• Verified date: January 2024
• Source: Case Comprehensive Cancer Center
• Contact: Samir Abraksia, MD
• Phone: 1-866-223-8100
• Email: TaussigResearch[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Cleveland Clinic, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Barriers faced to scheduling colorectal cancer screening	Percent of participants with barriers to receiving colorectal cancer screening.	At the end of education - 24 weeks