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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03640208
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : January 31, 2023
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE August 14, 2018
First Posted Date  ICMJE August 21, 2018
Last Update Posted Date January 31, 2023
Actual Study Start Date  ICMJE February 27, 2019
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2018)		 Difference in paired pre-/post-test score [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: August 17, 2018)		 Difference in paired pre-/post-test score [ Time Frame: From baseline (week 0) to follow-up (week 24) ]
16 item scales, where each item is assessed as true, false, or not sure. A 25% improvement between pre- and post-test scores will indicate an effective program
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2018)
  • Acceptability of intervention [ Time Frame: 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.
  • Feasibility of Intervention [ Time Frame: 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.
  • Fidelity of intervention [ Time Frame: 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.
  • Percentage of individuals aged 45-75 who have never had colon or rectal cancer screening [ Time Frame: At the end of education - 24 weeks ]
    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 [ Time Frame: 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.
  • Barriers faced to scheduling colorectal cancer screening [ Time Frame: At the end of education - 24 weeks ]
    Percent of participants with barriers to receiving colorectal cancer screening.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2018)
  • Acceptability of intervention [ Time Frame: At the end of education - 24 weeks ]
    Sum of seven point survey scored dichotomously or on a 5 point Likert scale
  • Feasibility of intervention as indicated by positive response to nine item dichotomous scale [ Time Frame: At the end of education - 24 weeks ]
    9 item dichotomous scale where a positive response to all questions indicates feasibility.
  • Number of documented deviations throughout the program [ Time Frame: At the end of education - 24 weeks ]
    Determines fidelity of intervention
  • Percentage of individuals aged 45-75 who have never had colon or rectal cancer screening [ Time Frame: At the end of education - 24 weeks ]
  • Percentage of participants who found the Risk assessment questionnaire helpful [ Time Frame: 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
  • Percent of participants needing primary care physician referrals [ Time Frame: At the end of education - 24 weeks ]
    Barriers faced to scheduling colorectal cancer screening
  • Percent of participants needing transportation [ Time Frame: At the end of education - 24 weeks ]
    Barriers faced to scheduling colorectal cancer screening
  • Percent of participants needing appointment coordination [ Time Frame: At the end of education - 24 weeks ]
    Barriers faced to scheduling colorectal cancer screening
  • Percent of participants needing financial assistance [ Time Frame: At the end of education - 24 weeks ]
    Barriers faced to scheduling colorectal cancer screening
  • Percent of participants needing a reminder call for appointment [ Time Frame: At the end of education - 24 weeks ]
    Barriers faced to scheduling colorectal cancer screening
  • Percent of participants needing education about colonoscopy preparation and procedure [ Time Frame: At the end of education - 24 weeks ]
    Barriers faced to scheduling colorectal cancer screening
  • Percent of primary care practitioners who did not refer the patient for colonoscopy. [ Time Frame: At the end of education - 24 weeks ]
    Barriers faced to scheduling colorectal cancer screening
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Educate, Assess Risk and Overcoming Barriers to Colorectal Screening Among African Americans
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Complete colorectal screening
11 step process divided into three phases: 1. Community Outreach Event; 2. Data Collection; 3. Navigation and Program Monitoring
Intervention: Behavioral: Education presented by trained caregiver
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 17, 2018)		 150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Samir Abraksia, MD 1-866-223-8100 TaussigResearch@ccf.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03640208
Other Study ID Numbers  ICMJE CASE10217
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Case Comprehensive Cancer Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Case Comprehensive Cancer Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Samir Abraksia, MD Cleveland Clinic, Case Comprehensive Cancer Center
PRS Account Case Comprehensive Cancer Center
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP