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Behavioural Intervention
FIT Kit Distribution Strategies for Colorectal Cancer Prevention
N/A
Recruiting
Led By Jungyoon Kim, PhD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months from the date of fit distribution
Awards & highlights
Study Summary
This trial compares two strategies for distributing FIT kits to increase colorectal screening rates among underserved African Americans. Onsite distribution vs direct mailing will be tested to determine which is more effective & cost-effective.
Who is the study for?
This trial is for African Americans aged 45-75 in Douglas County, NE who haven't kept up with colorectal cancer screenings. They must be able to communicate in English and provide contact info. People with a personal or family history of colorectal cancer, adenomas, or inflammatory bowel disease cannot join.Check my eligibility
What is being tested?
The study compares two ways of giving out FIT kits for colorectal cancer screening: handing them directly to people at DMV locations versus mailing them. It aims to see which method gets more people screened and is more cost-effective.See study design
What are the potential side effects?
Since the interventions involve non-invasive distribution methods of FIT kits rather than medications or procedures, there are no direct side effects associated with participating in this clinical trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months from the date of fit distribution
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months from the date of fit distribution
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fecal Immunochemical Test (FIT) kite return rate
Secondary outcome measures
Fecal Immunochemical Test (FIT) kit positive rate
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Onsite groupExperimental Treatment1 Intervention
The on-site distribution group will receive the Fecal Immunochemical Test (FIT) kits directly while visiting the Department of Motor Vehicles (DMV) location.
Participants in the on-site group will be guided through the process of receiving the FIT kits by trained 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 tailored educational brochure, reminder text messages, and phone calls within 3 weeks of the receipt of the FIT kit and post-navigation services for positive results.
Group II: Mailing groupActive Control1 Intervention
The mailing group participants will receive an initial letter from the the Nebraska Department of Health and Human Services (NE DHHS) asking whether they are interested in receiving Fecal Immunochemical Test (FIT) packets. For those who responded yes, NE DHHS will send FIT kits on behalf of the research team.
These participants will receive the FIT kits mailed to their provided addresses using the DMV database.
Participants in the mailing group will receive the FIT kits by mail along with detailed instructions on how to collect the stool sample and use the kit. The mailing group will also receive a tailored educational brochure, reminder text messages, and phone calls within three weeks of receipt of the FIT kit and post-navigation services in case of positive results.
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Who is running the clinical trial?
Robert Wood Johnson FoundationOTHER
158 Previous Clinical Trials
686,434 Total Patients Enrolled
University of NebraskaLead Sponsor
542 Previous Clinical Trials
1,143,647 Total Patients Enrolled
Jungyoon Kim, PhDPrincipal InvestigatorUniversity of Nebraska
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