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

Status Recruiting

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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Prevention

• NCT number: NCT05903885
• Study type: Interventional
• Source: University of Nebraska
• Contact: Jungyoon Kim, PhD
• Phone: (402) 552-7235
• Email: jungyoon.kim@unmc.edu
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2023
• Completion date: January 31, 2026