Mailed FIT Kits for Colorectal Cancer Screening

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Southern California
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if sending an extra FIT Kit (a take-home test for colon cancer) increases the number of completed and returned tests. The goal is to assess whether this additional mailing justifies the cost by measuring how many participants return their kits within 60 days. Participants are divided into two groups: one receives only the usual yearly kit, while the other receives a second kit in November. Ideal participants are those aged 60 to 74 who are due for a colon cancer screening and have previously returned a FIT Kit successfully. As an unphased trial, this study offers participants the chance to contribute to research that could enhance screening processes and potentially save lives.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on mailing and returning FIT Kits for colorectal cancer screening.

What prior data suggests that mailing additional FIT Kits is safe?

Research has shown that mailing fecal immunochemical test (FIT) kits is a safe way to encourage colorectal cancer screening. FIT kits are simple tests that detect hidden blood in stool, a potential cancer indicator. Studies have found that mailing these kits significantly increases screening rates, particularly in communities that might not otherwise participate.

No reports of harm have emerged from using these kits. They are non-invasive and can be completed at home, making them accessible for most people. As a common tool for cancer screening, the FIT kit's safety is well-established. Following the kit's instructions is crucial for obtaining the best results.12345

Why are researchers excited about this trial?

Researchers are excited about the Mailed Additional FIT Kit because it aims to improve colorectal cancer screening rates by simply sending a follow-up kit to individuals who might have missed their annual test. Unlike the standard care, which typically involves a single annual mailing of a FIT Kit, this approach introduces a second mailing to nudge individuals towards completing their screening. By increasing the chances of early detection through a simple, cost-effective measure, this method could significantly enhance participation rates and potentially save lives with minimal additional effort.

What evidence suggests that mailing additional FIT Kits could increase the return rate for colorectal cancer screening?

Research has shown that mailing Fecal Immunochemical Test (FIT) kits increases colorectal cancer screening rates. One study found that this method led to a 7.3% increase in screening compared to regular methods. Another study demonstrated that mailing FIT kits effectively raised screening rates in diverse, low-income communities. FIT kits are also considered a cost-effective way to improve screening among vulnerable groups. In this trial, participants in the "Mailed Additional FIT Kit" arm will receive an extra FIT kit in November 2024, along with the annual mailing, to evaluate whether this approach can further encourage more people to get screened for colorectal cancer.16789

Are You a Good Fit for This Trial?

This trial is for individuals aged 60 to 75 within a county health care system who are due for colorectal cancer screening. The study specifically looks at whether sending these patients an extra FIT Kit can improve the return rates for testing.

Inclusion Criteria

I am between 60 and 74 years old.
I am due for a colorectal cancer screening.
Not sent a FIT Kit in the past 3 months
See 1 more

Exclusion Criteria

Incarcerated
I am either younger than 60 or older than 74.
Sent a FIT Kit in the past 3 months
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive an additional mailed FIT Kit in November 2024

2 months
No in-person visits required

Follow-up

Participants are monitored for the return rate of the FIT Kits within 60 days of mailing

60 days

What Are the Treatments Tested in This Trial?

Interventions

  • Mailed Additional FIT Kit
Trial Overview The intervention being tested is the mailing of an additional FIT Kit to see if it increases the rate at which patients complete and return their kits. Patients are randomly chosen to either receive this extra kit or continue with usual care, which involves annual FIT Kit mailings.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Mailed Additional FIT KitExperimental Treatment1 Intervention
Group II: Usual Care (Annual FIT Kit Only)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials
956
Recruited
1,609,000+

Citations

Effectiveness and Cost-effectiveness of Mailed FIT in a Safety ...Mailed FIT is an effective and cost-effective population health strategy for CRC screening in vulnerable patients.
Mailed Outreach and Patient Navigation for Colorectal ...A mailed FIT outreach and patient navigation program led to a significant 7.3–percentage point increase in colorectal cancer (CRC) screening over usual care.
Cost-Effectiveness Analysis of Implementing a ...The cost per person screened was $20.6 for point-of-care distribution and $71.8 for the mailed FIT kit with follow-up services. Moreover, a review study ...
Default Mailed FIT Kits Is Most Effective Colorectal Cancer ...Usual care default mailed fecal immunochemical test (FIT) outreach was the most effective strategy to promote colorectal cancer screening to ...
A pragmatic randomized trial of mailed fecal immunochemical ...A regional mailed FIT intervention was effective for increasing CRC screening rates across CHC systems serving diverse, low-income populations.
Serial SMS Reminders and an Opt-out Mailed FIT Kits to ...The trial will test serial text message reminders and opt-out mailed fecal immunochemistry test (FIT) home kits against a simple reminder text message control.
Mailed FITs and Patient Navigation to Increase CRC ...Mailed fecal immunochemical tests (FITs) and patient navigation are some of the most reliably effective methods of increasing screening rates.
Increased Colorectal Cancer Screening Sustained with ...Organized mailed FIT outreach significantly increased colorectal cancer screening over multiple years in this safety-net health system.
Fecal Immunochemical Test (FIT) and Colonoscopy OutreachDesigned to increase colorectal cancer screening (CRC), this intervention has two components: (1) FIT outreach, which consists of a mailed letter, FIT test kit ...
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