Cancer Screening; Access; Awareness; Navigation

Not Applicable

Completed

• Conditions: Colorectal Cancer Screening
• Interventions: Other: Community-Based (Intervention Arm)

• Registration Number: NCT04131946
• Lead Sponsor: University of Illinois at Chicago

Brief Summary

To assess the feasibility and efficacy of community-based Colorectal Cancer (CRC) screening intervention in increasing CRC screening rates To evaluate individual-level knowledge related to CRC screening and risk factors To characterize individual -level facilitators and barriers to engaging in CRC screening and related diagnostic tests and treatment when applicable.

Detailed Description

To address the multiple determinants of health that impact CRC screening in the South Shore community in the University of Illinois Cancer Center's catchment area by conducting an experimental intervention to test the effectiveness of Fecal immunochemical test (FIT) tests dispensed by community stakeholders (community-dispensed) versus FIT tests dispensed using standard of care procedures by a clinic dispensed FIT test return rates. This study will follow American Cancer Society (ACS) guidelines for FIT testing, with the South Shore community area assigned to the intervention group (community-dispensed). CRC screening within the Mile Square Englewood Health Center, using standard of care, will serve as our control group to use for comparison (clinic-dispensed). The intervention will include a multifaceted approach to health education and community engagement focused on CRC led by a team of trusted health champions (community leaders, a barber, a hair salon, and community health workers) in the South Shore community area.

Study Timeline

• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2019-10-16
• Study First Posted: 2019-10-18
• Study Start: 2019-11-12
• Primary Completion: 2021-12-20
• Study Completion: 2021-12-20
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-14
• Last Update Posted: 2022-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Male or female ages 45-74
• Speaks English and resides in or near the South Shore community area or utilizes the Mile Square Englewood Heath Center
• Have not had CRC screening in the previous 12 months

Exclusion Criteria

• Adults ages <45 or >75
• Does not speak English
• Does not reside in or near the South Shore Community area and do not utilize Mile Square Englewood Heath Center
• Have had CRC screening in the previous 12 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Community Intervention Group/Arm 1	Community-Based (Intervention Arm)	Community navigators will work with local businesses (barber shop, hair salon) to identify and screen eligible community members within or near the South Shore community area. The navigator will engage with each potential participant using the attached script. If the participant is interested, the navigator will document the participant's contact information, and assist the participant in obtaining and returning their FIT. Community navigators will attend community events to post the informational flyer and provide education about CRC to community members. At these events, they will identify and screen eligible community members within or near the South Shore community area. The navigator will engage with each potential participant using the attached script. If the participant is interested, the navigator will document the participant's contact information, and assist the participant in obtaining and returning their FIT.

Primary Outcome Measures

Name	Time	Method
Evaluate individual-level knowledge related to CRC screening and risk factors	3 years	Assess knowledge related to CRC screening and risk factors as measured by our short survey that participants will return with their FIT. We will summarize the frequency and percentage of respondents who have had a prior CRC screening, in addition to the frequency and percentage of respondents who select the correct answers on knowledge questions.
To assess the feasibility and efficacy of conducting a community-based CRC screening intervention in increasing CRC screening rates	3 years	Evaluate feasibility and efficacy of conducting a community-based navigation program for CRC screening. In both arms of the study, we will examine the number of participants provided with health education about colorectal cancer, number of FITs distributed, and number of FITs returned. We will summarize the number of persons screened positive and negative, and determine the proportion of positive screening who are referred to clinical care, and at the Mile Square South Shore and Englewood sites through our community navigation program (intervention) and existing MSHC lay clinical navigation program. We will compare the FIT return rate and average return time at the South Shore and Englewood sites to determine if the rates and times are similar. We will also determine return rates and times for participants who screen positive and are navigated to return the MSHC for diagnostic testing, and make comparisons across the intervention and control arms
Characterize individual -level facilitators and barriers to engaging in CRC screening and related diagnostic tests and treatment when applicable	3 years	Evaluate facilitators and barriers people living in or near the South Shore communities experience related to CRC screening and related follow-up. We will summarize the respondent responses to survey questions about barriers and facilitators

Trial Locations

Locations (2)

Mile Square Health Center - Englewood; 🇺🇸 Chicago, Illinois, United States

University of Illinois; 🇺🇸 Chicago, Illinois, United States