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

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Colorectal Cancer

Treatments: Behavioral: Education presented by trained caregiver

Study type: Interventional

Funder types: Other

Identifiers

NCT03640208

CASE10217

Details and patient eligibility

About

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

Full 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

Enrollment: 163 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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163 participants in 1 patient group

Complete colorectal screening

Experimental group

Description:

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

Treatment:

Behavioral: Education presented by trained caregiver