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OpenTrials
Completed

NCT Number: NCT04131946

Cancer Screening; Access; Awareness; Navigation

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.

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Key information

Conditions

Colorectal Cancer Screening

Age range

45 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mile Square Health Center - Englewood, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Community-Based (Intervention Arm)

Other

Community dispensed FIT

Primary outcomes

  1. To assess the feasibility and efficacy of conducting a community-based CRC screening intervention in increasing CRC screening rates

    Time frame: 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

  2. Evaluate individual-level knowledge related to CRC screening and risk factors

    Time frame: 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.

  3. Characterize individual -level facilitators and barriers to engaging in CRC screening and related diagnostic tests and treatment when applicable

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 18, 2019
Registry last updated
Dec 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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