Trial Title:
A Cross-sectional Partnership to Improve Prevention
NCT ID:
NCT05903885
Condition:
Colorectal Cancer
Prevention
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
Prevention
Department of motor vehicles
Cross-sectoral partnership
African Americans
Screening
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
The on-site distribution group will receive FIT kits at a designated DMV location (4606 N
56th St, Omaha, NE) distributed by research staff, while the on-site with social media
advertising group will receive FIT kits at the same location but with additional exposure
to targeted ads on Facebook, Instagram, and YouTube. The social media campaign will run
from August 19 to October 29, 2024, targeting African American residents of Omaha, aged
45-75. Both groups will receive a free FIT kit, prepaid return envelope, educational
brochure, reminder messages, and post-FIT navigation support if needed. Participants'
information and perceptions will be collected via surveys. FIT return rate, positive
screening rate, and follow-up colonoscopy completion rate will be compared between
groups, controlling for covariates. The study aims to recruit 1,200 participants (600 per
group) over 3-6 months to evaluate these strategies in improving colorectal cancer
screening rates among African Americans.
Primary purpose:
Prevention
Masking:
Single (Participant)
Intervention:
Intervention type:
Other
Intervention name:
On-site Fecal Immunochemical Test (FIT) Kit Distribution
Description:
Participants will receive home based Fecal Immunochemical Test (FIT) kit directly at the
DMV site by the research staff.
Arm group label:
Onsite group
Other name:
Face-to-face distribution
Intervention type:
Other
Intervention name:
Onsite with social media advertising Fecal Immunochemical Test (FIT) Kit Distribution
Description:
Participants will receive home-based Fecal Immunochemical Test (FIT) kits directly at the
DMV location through face-to-face contact, supplemented by exposure to targeted social
media advertisements.
Arm group label:
On-site with social media advertising group
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 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.
Detailed 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.
Criteria for eligibility:
Criteria:
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).
Gender:
All
Minimum age:
45 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Department of Motor Vehicles (DMV)
Address:
City:
Omaha
Zip:
68104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jungyoon Kim, PhD
Phone:
402-552-7235
Email:
beatcancer@unmc.edu
Facility:
Name:
Douglas County Treasurer's Office
Address:
City:
Omaha
Zip:
68104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jungyoon Kim, PhD
Phone:
402-552-7235
Email:
beatcancer@unmc.edu
Start date:
October 2, 2023
Completion date:
January 2026
Lead sponsor:
Agency:
University of Nebraska
Agency class:
Other
Collaborator:
Agency:
Robert Wood Johnson Foundation
Agency class:
Other
Source:
University of Nebraska
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05903885
