A Cross-sectional Partnership to Improve Prevention

University of Nebraska

Status: Enrolling

Conditions: Prevention; Colorectal Cancer

Treatments: Other: On-site Fecal Immunochemical Test (FIT) Kit Distribution; Other: Onsite with social media advertising Fecal Immunochemical Test (FIT) Kit Distribution

Study type: Interventional

Funder types: Other

Identifiers

NCT05903885

0115-23-EP

Details and patient eligibility

About

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 combined with social media advertising result in higher return rates compared to on-site distribution alone?
• Which distribution strategy (on-site alone vs. on-site with social media advertising) is a more effective approach for increasing colorectal cancer screening rates among underserved populations?

Participants in the study will be African Americans aged 45-75 who are eligible for colorectal cancer screening. Participants will be assigned to one of two groups: the on-site distribution group or the on-site distribution with social media advertising group. In both groups, participants will be given FIT kits at a designated Department of Motor Vehicle (DMV) service location. 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 aims to recruit a total of 1,200 participants (600 per group) and will assess FIT kit return rates, positive screening rates, and completion rates of follow-up colonoscopies after positive FIT results.

Full 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 the Department of Motor Vehicles (DMV), to recruit AAs who are eligible for CRC screening. This study will test different 'distribution' strategies (onsite alone vs. onsite with social media advertising) 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 (4606 N 56th St Ste100, Omaha, NE 68104) to recruit participants face-to-face, and the investigator's research staff will distribute screening kits on-site (n=600). For the onsite with social media advertising strategy, in addition to the onsite distribution, the investigators will implement a targeted social media campaign on platforms including Facebook, Instagram, and YouTube to enhance awareness and potentially increase participation (n=600). The social media campaign will run from August 19, 2024, to October 29, 2024, targeting African American residents of Omaha, Nebraska, aged 45-75 years.

All participants will receive 1) a free Fecal Immunochemical Test (FIT) kit with a prepaid return envelope, 2) a culturally tailored educational brochure, 3) reminder text messages and calls, and 4) 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.

Upon consent, participants' demographic and screening-related information will be collected via a paper-based registration survey (e.g., name, age, gender, race/ethnicity, address, healthcare access, recent CRC screening history, smoking status, and personal/family history of CRC). Participants' perceptions and beliefs about screening will be collected via an online survey through text message 3-5 days after participants receive the screening kit. Kit return status and results will be collected via a participant tracking log shared by key personnel in the partnership using a REDCap system.

Outcomes (screening completion rate and positive results) will be compared between the onsite and onsite with social media advertising groups, controlling for other covariates (age, gender, income, previous screening, smoking status, healthcare access, and health beliefs). The study will also assess the cost-effectiveness of each strategy and the completion rate of follow-up colonoscopies after receiving positive FIT results.

The study aims to recruit a total of 1,200 participants (600 per group) over a period of 3-6 months. Follow-up services, including assistance with scheduling colonoscopies and applying for financial support programs, will be provided by a health navigator at Charles Drew Health Center for participants with positive results or those without health insurance or a primary care provider.

This research aims to develop, deliver, and evaluate an evidence-based colorectal cancer screening (CRCS) program for AAs through a community cross-sectoral partnership, with the ultimate goal of reducing racial disparities in colorectal cancer screening and outcomes.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,200 participants in 2 patient groups

Onsite group

Experimental group

Description:

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 Ste100, Omaha, NE 68104. Participants in the on-site group will be guided through the process of receiving the FIT kits by trained research staff present at the designated location. 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 the receipt of the FIT kit. Post-FIT navigation support will be provided for those with positive results or without a family doctor/insurance.

Treatment:

Other: On-site Fecal Immunochemical Test (FIT) Kit Distribution

On-site with social media advertising group

Active Comparator group

Description:

The onsite with social media advertising group participants will receive FIT kits directly at the DMV location, similar to the onsite group. 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.

Treatment:

Other: Onsite with social media advertising Fecal Immunochemical Test (FIT) Kit Distribution