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Cancer Screening; Access; Awareness; Navigation

NCT ID: NCT04131946

Last Updated: 2022-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-12

Study Completion Date

2021-12-20

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer Screening

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Experimental and Standard of care arms
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Community-Based (Intervention Arm)

Intervention Type OTHER

Community dispensed FIT

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Community-Based (Intervention Arm)

Community dispensed FIT

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Karriem S. Watson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karriem S Watson, DHSc

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

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University of Illinois

Chicago, Illinois, United States

Site Status

Mile Square Health Center - Englewood

Chicago, Illinois, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2019-0920

Identifier Type: -

Identifier Source: org_study_id