Educate, Assess Risk and Overcoming Barriers to Colorectal Screening Among African Americans
- Conditions
- Colorectal Cancer
- Interventions
- Behavioral: Education presented by trained caregiver
- Registration Number
- NCT03640208
- Lead Sponsor
- Case Comprehensive Cancer Center
- 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
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 163
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Complete colorectal screening Education presented by trained caregiver 11 step process divided into three phases: 1. Community Outreach Event; 2. Data Collection; 3. Navigation and Program Monitoring
- Primary Outcome Measures
Name Time Method Difference in paired pre-/post-test score 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 Outcome Measures
Name Time Method Feasibility of Intervention 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.Percentage of individuals aged 45-75 who have never had colon or rectal cancer screening At the end of education - 24 weeks Percentage of individuals aged 45-75 who have never had colon or rectal cancer screening
Fidelity of intervention 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.Acceptability of intervention 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.
Barriers faced to scheduling colorectal cancer screening At the end of education - 24 weeks Percent of participants with barriers to receiving colorectal cancer screening.
Percentage of participants who found the Risk assessment questionnaire helpful 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.
Trial Locations
- Locations (1)
Cleveland Clinic, Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States