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

Primary Purpose

Colorectal Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Education presented by trained caregiver

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring health disparities, African American, risk assessment, secondary prevention

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts 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

Sites / Locations

Cleveland Clinic, Case Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Complete colorectal screening

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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.

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.

Percentage of individuals aged 45-75 who have never had colon or rectal cancer screening

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.

Barriers faced to scheduling colorectal cancer screening

Percent of participants with barriers to receiving colorectal cancer screening.

Full Information

NCT ID

NCT03640208

First Posted

August 14, 2018

Last Updated

August 21, 2023

Sponsor

Case Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT03640208

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 27, 2019 (Actual)

Primary Completion Date

January 1, 2024 (Anticipated)

Study Completion Date

April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

health disparities, African American, risk assessment, secondary prevention

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Complete colorectal screening

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Education presented by trained caregiver

Intervention Description

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 Outcome Measure Information:

Title

Difference in paired pre-/post-test score

Description

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

Time Frame

From baseline (week 0) to follow-up end of study (week 24)

Secondary Outcome Measure Information:

Title

Acceptability of intervention

Description

Time Frame