- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04131946
Cancer Screening; Access; Awareness; Navigation
Assessing the Effectiveness of a Community-Based Colorectal Cancer Screening Intervention
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- University of Illinois
-
Chicago, Illinois, United States, 60621
- Mile Square Health Center - Englewood
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Community Intervention Group/Arm 1
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. |
Community dispensed FIT
|
No Intervention: Standard of Care (Control) Arm 2
These procedures are a detailed summary of the existing lay navigation program at Mile Square Health Center (MSHC). These procedures are unrelated to our research, except to demonstrate how the existing navigation program from which we will obtain deidentified data works. Lay clinic navigator use clinic schedules and walk-ins to identify and screen eligible participants within the Englewood MSHC. The navigator engages with each potential participant using standard scripted language. For interested patients, the navigator documents interest and FIT dispensing as appropriate, and assists the patient in obtaining and returning their FIT. Lay clinic navigators attend community events as normally scheduled to provide community-based health education and referral to the MSHC. At these events, they identify and screen eligible community members within the Englewood community area. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 years
|
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 years
|
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
|
3 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Karriem S Watson, DHSc, University of Illinois at Chicago
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-0920
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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