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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

Study Description
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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


Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: Education presented by trained caregiver Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : February 27, 2019
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Complete colorectal screening
11 step process divided into three phases: 1. Community Outreach Event; 2. Data Collection; 3. Navigation and Program Monitoring
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.


  3. 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.


  4. 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

  5. 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.

  6. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03640208


Contacts
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Contact: Samir Abraksia, MD 1-866-223-8100 TaussigResearch@ccf.org

Locations
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United States, Ohio
Cleveland Clinic, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44122
Contact: Samir Abraksia, MD    866-223-8100    TaussigResearch@ccf.org   
Principal Investigator: Samir Abraksia, MD         
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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Principal Investigator: Samir Abraksia, MD Cleveland Clinic, Case Comprehensive Cancer Center
More Information
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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03640208    
Other Study ID Numbers: CASE10217
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: January 31, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Case Comprehensive Cancer Center:
health disparities
African American
risk assessment
secondary prevention
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases