Recruiting

FIT Kit

Sponsor:

University of Nebraska

Code:

NCT05903885

Conditions

Colorectal Cancer

Prevention

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Interventions

On-site Fecal Immunochemical Test (FIT) Kit Distribution

On-site With Social Media Advertising Fecal Immunochemical Test (FIT) Kit Distribution

Study Details

Brief summary:

African Americans face racial disparities in colorectal cancer (CRC), with lower screening rates and higher incidence and mortality rates. To address this gap and improve CRC screening rates, investigators aims to recruit a total of 1,200 African American participants aged 45-75 during their visits to the DMV, 4606 N 56th St Ste100, Omaha, for CRC screening. All participants will receive a free Fecal Immunochemical Test (FIT) kit with a prepaid return envelope, a culturally tailored educational brochure, reminder text messages and calls, and post-FIT navigation support for participants with positive results or without family doctor/insurance. Kits are returned to a designated Nebraska Medicine lab for testing, and test results will be mailed to participants within 14-21 days. Participants will be assigned to one of two groups: the on-site distribution group or the on-site distribution group with social media advertising group. The social media advertising group will additionally be exposed to targeted ads on platforms like Facebook, Instagram, and YouTube to increase awareness and potentially improve participation rates. The study will compare FIT kit return rates, positive screening rates, and completion rates of follow-up colonoscopies after positive FIT results between the two groups.

Conditions

Colorectal Cancer

Prevention

Study ID

NCT05903885

Start date

Oct 2, 2023

Status verified date

May, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Self-identification as Black or African American
  • Between 45 and 75 years old
  • Not up-to-date with colorectal cancer (CRC) screening per guidelines
  • Willingness to provide contact information for follow-up
  • Ability to speak, read, and write English
  • Current residency in Douglas County, NE.

Exclusion Criteria:

  • History of colorectal cancer (CRC)
  • History of adenomas (precancerous polyps) or inflammatory bowel disease
  • Family history of colorectal cancer (CRC)

Study Design

Enrollment

1200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: On-site Group

The on-site distribution group will receive the Fecal Immunochemical Test (FIT) kits directly while visiting the Department of Motor Vehicles (DMV) location at 4606 N 56th St Suite 100, Omaha, NE 68104.

Participants in the on-site group will be guided through the kit process by trained research staff present. They will be given instructions on collecting the stool sample and using the FIT kit properly.

They will also be given a culturally tailored educational brochure, a prepaid return envelope, and receive reminder text messages and phone calls within 3 weeks of receipt of the FIT kit. Post-FIT navigation support will be provided for those with positive results or without a family doctor/insurance.

active comparator: On-site Group With Social Media Advertising

The onsite group with social media advertising participants will receive FIT kits directly at the Department of Motor Vehicles (DMV) location at 4606 N 56th St Suite 100, Omaha, NE 68104. Additionally, they will be exposed to targeted social media advertisements on Facebook, Instagram, and YouTube.

These participants will encounter ads featuring video content with community member testimonials, emphasizing the importance of colorectal cancer screening for African Americans aged 45-75. The campaign will run from August 19 to October 29, 2024.

Participants in this group will receive the FIT kits at the DMV along with detailed instructions on how to collect the stool sample and use the kit. They will also receive a culturally tailored educational brochure, prepaid return envelope, reminder text messages, and phone calls within three weeks of receipt of the FIT kit. Post-FIT navigation support will be provided for those with positive results or without a family doctor/insurance.

Interventions

On-site Fecal Immunochemical Test (FIT) Kit Distribution

Participants will receive home based Fecal Immunochemical Test (FIT) kit directly at the Department of Motor Vehicles (DMV) location at 4606 N 56th St Suite 100, Omaha, NE 68104, by research staff.

On-site With Social Media Advertising Fecal Immunochemical Test (FIT) Kit Distribution

Participants will receive home-based Fecal Immunochemical Test (FIT) kits directly at the Department of Motor Vehicles (DMV) location at 4606 N 56th St Suite 100, Omaha, NE 68104, by research staff supplemented by exposure to targeted social media advertisements.

Primary outcome measure

  • Fecal Immunochemical Test Kit Return Rate [ Time Frame: 6 months from date of FIT distribution ]

Central Contacts and Locations

Central contacts

Jungyoon Kim, PhD

(402) 552-7235jungyoon.kim@unmc.edu

Locations

Department of Motor Vehicles (DMV)

Recruiting

Omaha, Nebraska, United States, 68104

Contacts

Jungyoon Kim, PhD

402-552-7235beatcancer@unmc.edu

Douglas County Treasurer's Office

Recruiting

Omaha, Nebraska, United States, 68104

Contacts

Jungyoon Kim, PhD

402-552-7235beatcancer@unmc.edu

More Information

Sponsor

University of Nebraska

Last update posted

Feb 10, 2026

Last verified

May, 2025

Keywords

  • Prevention
  • Department of motor vehicles
  • Cross-sectoral partnership
  • African Americans
  • Screening

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Nebraska on 2026-02-10.