Cancer Screening; Access; Awareness; Navigation

Colorectal Cancer Screening Clinical Trial

Official title:

Assessing the Effectiveness of a Community-Based Colorectal Cancer Screening Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04131946
• Other study ID #: 2019-0920
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Colorectal Cancer Screening
• Colorectal Neoplasms

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