Cancer Screening; Access; Awareness; Navigation

NCT04131946 | Completed

• 1 other identifier: 2019-0920
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

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.

Conditions

Colorectal Cancer Screening

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Community Intervention Group/Arm 1

EXPERIMENTAL

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.

Other: Community-Based (Intervention Arm)

Standard of Care (Control) Arm 2

NO INTERVENTION

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.

Interventions

Community-Based (Intervention Arm) OTHER

Community dispensed FIT

Community Intervention Group/Arm 1

Eligibility Criteria

• Age: 45 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (2)

University of Illinois

Chicago, Illinois, 60612, United States

Location

Mile Square Health Center - Englewood

Chicago, Illinois, 60621, United States

Location

Study Officials

• Karriem S Watson, DHSc

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Experimental and Standard of care arms

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 18, 2019
• Study Start: November 12, 2019
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: December 19, 2022

Record last verified: 2022-12

Locations

US (2)