A Cross-sectional Partnership to Improve Prevention

Colorectal Cancer Clinical Trial

Official title:

Using a Cross-sectional Partnership to Improve Prevention and Health Equity Among African Americans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05903885
• Other study ID #: 0115-23-EP
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: January 31, 2026

Study information

• Verified date: October 2023
• Source: University of Nebraska
• Contact: Jungyoon Kim, PhD
• Phone: (402) 552-7235
• Email: jungyoon.kim[@]unmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a non-randomized, 2-arm clinical trial comparing the effectiveness of two strategies for distributing FIT (fecal immunochemical test) kits in a community-based colorectal cancer screening program targeting African Americans (AAs). The main questions this study aims to answer are:

• Does the on-site distribution of FIT kits result in higher return rates compared to direct mailing?

• Which distribution strategy (onsite vs. direct mailing) is a more cost-effective approach for increasing colorectal cancer screening rates among underserved populations?

Participants in the study will be African Americans who are eligible for colorectal cancer screening. Participants will be assigned to one of two groups: the on-site distribution group or the direct mailing group. In the on-site distribution group, participants will be given FIT kits at a designated Department of Motor Vehicle (DMV) service location. In the direct mailing group, participants will receive the FIT kits through the mail using the DMV database.

Description:

African Americans (AAs) face racial disparities in colorectal cancer (CRC), with higher incidence and mortality rates, as well as lower screening rates. To address this gap and improve CRC screening rates among AAs, this study will use an evidence-based, community-based intervention program partnering with multiple cross-sectoral organizations, such as DMV, to recruit AAs who are eligible for CRC screening. This study will test different 'distribution' strategies (onsite vs. mailing) using the resources from the partner organizations. For the onsite strategy, the investigators will set up a health promotion booth at a selected DMV location to recruit participants face-to-face, and the investigator's research staff will distribute screening kits on-site (n=600). For the mailing strategy, the investigators will collaborate with the Nebraska Department of Health and Human Services (DHHS) to mail out screening kits to eligible participants using DMV Driver's License Database (n=600). All participants will receive 1) a free screening kit with a prepaid return envelope, 2) a tailored educational brochure, 3) reminder text/calls, and 4) post-navigation services in case of positive results. Fecal Immunochemical Test (FIT) will be used. Kits are returned to a designated lab location for testing, and test results will be mailed to participants within 14-21 days. Upon consent, participants' demographic and screening-related information will be collected via the registration form (e.g., name, contact information, race, gender, previous screening history, etc.). Participants' perceptions and beliefs about screening will be collected via an online survey through text message 3 days after participants receive the screening kit. Kit return status and results will be collected via the participant tracking log shared by the key personnel in the partnership. Outcomes (screening completion rate and positive results) will be compared between the onsite and mailing groups, controlling for other covariates (age, gender, race, healthcare access, income, previous screening history, and health beliefs).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: January 31, 2026
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• Self-identification as Black or African American.

• Age between 45 and 75 years.

• 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:

• Individuals with a personal history of colorectal cancer (CRC).

• Individuals with a personal history of adenomas (precancerous polyps) or inflammatory bowel disease.

• Individuals with a family history of colorectal cancer (CRC).

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Prevention

Intervention

Other:
• On-site Fecal Immunochemical Test (FIT) Kit Distribution
Participants will receive home based Fecal Immunochemical Test (FIT) kit directly at the DMV site by the research staff.
• Mailed Fecal Immunochemical Test (FIT) Kit Distribution
Participants will receive home based Fecal Immunochemical Test (FIT) kit directly by mailing without any personal (face-to-face) contact.

Locations

Country	Name	City	State
United States	Department of Motor Vehicles (DMV)	Omaha	Nebraska
United States	Douglas County Treasurer's Office	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal Immunochemical Test (FIT) kite return rate	Proportion of participants who have completed the screening by returning Fecal Immunochemical Test (FIT) kits	6 months from the date of FIT distribution
Secondary	Fecal Immunochemical Test (FIT) kit positive rate	Proportion of participants who have positive Fecal Immunochemical Test (FIT) kit results	6 months from the date of FIT distribution