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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04131946
Other study ID # 2019-0920
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 12, 2019
Est. completion date December 20, 2021

Study information

Verified date December 2022
Source University of Illinois at Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date December 20, 2021
Est. primary completion date December 20, 2021
Accepts healthy volunteers No
Gender All
Age group 45 Years to 74 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Community-Based (Intervention Arm)
Community dispensed FIT

Locations

Country Name City State
United States Mile Square Health Center - Englewood Chicago Illinois
United States University of Illinois Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To assess the feasibility and efficacy of conducting a community-based CRC screening intervention in increasing CRC screening rates 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 3 years
Primary Evaluate individual-level knowledge related to CRC screening and risk factors 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. 3 years
Primary Characterize individual -level facilitators and barriers to engaging in CRC screening and related diagnostic tests and treatment when applicable 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 3 years
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