FIT Kit Strategies for Colorectal Cancer Screening

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ohio State University Comprehensive Cancer Center
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 improve colorectal cancer screening by testing various methods of delivering a fecal immunochemical test (FIT), which detects blood in the stool. It compares standard and enhanced FIT kits, along with different support methods, such as text messages or phone calls, to assist completion. The goal is to identify the best combination to increase screening rates. The trial seeks residents of Appalachian counties who have had a medical visit in the past two years, are at average risk for colorectal cancer, and are not up-to-date with their screenings. As an unphased trial, this study provides a unique opportunity to contribute to innovative screening methods that could enhance early detection and save lives.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these FIT kit strategies are safe for colorectal cancer screening?

Research shows that fecal immunochemical test (FIT) kits are safe and easy to use for colorectal cancer screening. Studies have found that both enhanced and standard FIT kits effectively detect signs of colorectal cancer with minimal risk. Participants in outreach programs have found the enhanced FIT kit acceptable, while the standard FIT kit remains a reliable choice for home testing. Both kits are noninvasive, avoiding surgery or body entry, which reduces the chance of side effects. No evidence suggests serious problems from using these kits. They are widely recommended for yearly screening in individuals at average risk for colorectal cancer.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring innovative strategies to boost colorectal cancer screening using FIT kits. Unlike the standard of care, which typically involves a single FIT kit without additional support, this trial is testing enhanced FIT kits alongside personalized patient navigation via text messages or phone calls. This approach could improve screening rates by making it easier for people to complete the tests and follow up on results. By tailoring the support to individual needs, these strategies aim to catch cancer earlier, potentially improving outcomes and saving lives.

What evidence suggests that this trial's strategies could be effective for improving colorectal cancer screening rates?

Studies have shown that fecal immunochemical tests (FIT) effectively detect early-stage colorectal cancer and cost less than more invasive tests. About 60% of patients using FIT at home detected early-stage cancer. In this trial, participants will receive either a standard or enhanced FIT kit. Research indicates that both standard and enhanced FIT kits effectively screen for colorectal cancer. The enhanced FIT kit includes extra features to aid in cancer detection, but both types are strong at detecting it. While ongoing research aims to understand the long-term effects on survival rates, FIT kits are generally considered a reliable screening tool.56789

Who Is on the Research Team?

PR

Paul Reiter, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals in Appalachia who are due for colorectal cancer screening. It's not specified who can't join, but typically those with a recent colonoscopy or health issues affecting the test might be excluded.

Inclusion Criteria

Resident of an Appalachian county
Medical visit at a participating health system in the past two years
I am at average risk for colorectal cancer.
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 a FIT kit and patient navigation via telephone or text message

8 weeks

Follow-up

Participants are monitored for the return of the completed FIT kit

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Enhanced FIT kit
  • Standard FIT kit
  • Telephone patient navigation
  • Text message patient navigation
Trial Overview The study tests if enhanced FIT kits or standard ones work better when mailed to patients. It also looks at whether getting help through phone calls or text messages increases people's chances of completing the test.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Group D (enhanced FIT kit plus text message PN)Experimental Treatment2 Interventions
Group II: Group C (enhanced FIT kit plus telephone PN)Experimental Treatment2 Interventions
Group III: Group B (standard FIT kit plus text message PN)Experimental Treatment2 Interventions
Group IV: Group A (standard FIT kit plus telephone PN)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials
350
Recruited
295,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

Effectiveness of fecal immunochemical testing in reducing ...The effectiveness of fecal immunochemical testing (FIT) in reducing colorectal cancer (CRC) mortality has not yet been fully assessed in a large, population ...
Long-Term Effectiveness Associated With Fecal ...This cohort study evaluates whether initiating fecal immunochemical test screening at age 40 to 49 years, rather than at the currently ...
Colorectal Yield and Effectiveness of 2-Sample Fecal ...The risk of colorectal cancer incidence and mortality were relatively similar among positive fecal immunochemical test (FIT)/colonoscopy compliers but higher ...
Study finds less expensive noninvasive test is an effective ...About 60% of patients taking both tests at home had early-stage cancer, but a fecal immunochemical test detected it at one-fifth the cost ...
First-Round Fecal Immunochemical Test Concentration...Enhancing fecal immunochemical test (FIT)–based colorectal cancer (CRC) screening requires identifying additional predictive factors for ...
Summary of Safety and Effectiveness Data (SSED)A personal history of colorectal cancer or advanced precancerous lesions. • A positive result from another colorectal cancer screening method ...
Implementing an enhanced mailed FIT program to improve ...Our findings demonstrate that an enhanced mailed FIT program using primers and reminders was acceptable. Our findings can help other FQHCs implement and ...
The Impact of Choice on Colorectal Cancer ScreeningUCLA Health previously implemented a fecal immunochemical test (FIT) outreach program wherein FIT kits are mailed to average-risk patients overdue for CRC ...
Screening for Colorectal Cancer - Stool DNA TestingUse this page to view details for the decision Memo for Screening for Colorectal Cancer - Stool DNA Testing (CAG-00440N).
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