Clinical trial NCT03640208: 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
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: health disparities
African American
risk assessment
secondary prevention
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

Eligibility 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

Primary outcomes:
measure: Difference in paired pre-/post-test score
timeFrame: From baseline (week 0) to follow-up end of study (week 24)
Secondary outcomes:
measure: Acceptability of intervention
timeFrame: At the end of education - 24 weeks
measure: Feasibility of Intervention
timeFrame: At the end of education - 24 weeks
measure: Fidelity of intervention
timeFrame: At the end of education - 24 weeks
measure: Percentage of individuals aged 45-75 who have never had colon or rectal cancer screening
timeFrame: At the end of education - 24 weeks
measure: Percentage of participants who found the Risk assessment questionnaire helpful
timeFrame: At the end of education - 24 weeks
measure: Barriers faced to scheduling colorectal cancer screening
timeFrame: At the end of education - 24 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic, Case Comprehensive Cancer Center
name: Samir Abraksia, MD
role: PRINCIPAL_INVESTIGATOR
References: