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Cancer Screening; Access; Awareness; Navigation

Primary Purpose

Colorectal Cancer Screening

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Community-Based (Intervention Arm)
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer Screening

Eligibility Criteria

45 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Illinois
  • Mile Square Health Center - Englewood

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Community Intervention Group/Arm 1

Standard of Care (Control) Arm 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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.
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

Secondary Outcome Measures

Full Information

First Posted
October 16, 2019
Last Updated
December 14, 2022
Sponsor
University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT04131946
Brief Title
Cancer Screening; Access; Awareness; Navigation
Official Title
Assessing the Effectiveness of a Community-Based Colorectal Cancer Screening Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
November 12, 2019 (Actual)
Primary Completion Date
December 20, 2021 (Actual)
Study Completion Date
December 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental and Standard of care arms
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Community Intervention Group/Arm 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care (Control) Arm 2
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Community-Based (Intervention Arm)
Intervention Description
Community dispensed FIT
Primary Outcome Measure Information:
Title
To assess the feasibility and efficacy of conducting a community-based CRC screening intervention in increasing CRC screening rates
Description
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
Time Frame
3 years
Title
Evaluate individual-level knowledge related to CRC screening and risk factors
Description
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.
Time Frame
3 years
Title
Characterize individual -level facilitators and barriers to engaging in CRC screening and related diagnostic tests and treatment when applicable
Description
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
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karriem S Watson, DHSc
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Mile Square Health Center - Englewood
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60621
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Cancer Screening; Access; Awareness; Navigation

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