Colorectal Cancer Screening Program for Underserved Communities

Recruiting in Palo Alto (17 mi)

Overseen by Juliana M Kling

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Mayo Clinic

Disqualifiers: Colorectal cancer, Colon polyps, others

No Placebo Group

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

This clinical trial studies disparities involving colorectal cancer prevention and screening in Black and underserved communities in the Phoenix metropolitan area. The Black community is disproportionately impacted by colorectal cancer, with the highest rate of any racial/ethnic group in the United States. There are complex reasons behind these disparities, largely related to socioeconomic factors and healthcare access. Providing access to free, home-based fecal immunochemical testing (FIT), colorectal screening education, and appropriate follow-up to predominantly Black community-based organizations and underserved communities may help to close this gap.

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 data supports the effectiveness of the treatment Educational Intervention, PRE-ACT Model, Patient Navigator Model, Fecal Immunochemical Test, FIT, Fecal Occult Blood Test (FOBT), Stool Test, Patient Navigation, Patient Navigation Services, Care Coordination, Healthcare Navigation, Questionnaire Administration, Survey Administration, Assessment Tool for colorectal cancer screening?

Research shows that mailing fecal immunochemical tests (FIT) can improve colorectal cancer screening rates, and using fecal occult blood tests (FOBT) in screening programs can reduce mortality from colorectal cancer. Transitioning to FIT from older methods has also improved detection rates of colorectal cancer and related conditions. ^{1 2 3 4 5}

Is the fecal occult blood test (FOBT) safe for colorectal cancer screening?

The fecal occult blood test (FOBT), including its immunochemical version (FIT), is widely used and recommended for colorectal cancer screening, with no significant safety concerns reported in the studies. ^{2 6 7 8 9}

How is the Fecal Immunochemical Test (FIT) different from other treatments for colorectal cancer?

The Fecal Immunochemical Test (FIT) is unique because it directly measures human hemoglobin in stool, making it more specific and easier to use than the traditional fecal occult blood test (FOBT). Unlike other screening methods like colonoscopy, FIT is non-invasive and can be done at home, which may increase participation in screening programs, especially in underserved communities. ^{7 8 9 10 11}

Eligibility Criteria

This trial is for individuals aged 45 or older in the Phoenix area, particularly from Black and underserved communities. Eligible participants should not have a family history of colorectal cancer diagnosed before age 60, no recent GI symptoms, no colonoscopy in the past 5 years, and no FIT test within the last year.

Inclusion Criteria

I am 45 years old or older.

I do not have current GI or rectal symptoms.

Have not had a fecal immunochemical test (FIT) test within the last year

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Screening and Education

Participants receive free FIT tests, education on colorectal cancer screening, and complete a questionnaire about colorectal cancer screening and healthcare.

Up to 30 days

Home-based self-collection

Follow-up

Participants with a positive FIT test are followed up by a patient navigator to discuss next steps and consultation with a gastroenterologist. Follow-up occurs at 2 and 4 weeks after initial outreach.

4 weeks

2 visits (virtual or in-person)

Treatment Details

Interventions

• Educational Intervention (Other)
• Fecal Immunochemical Test ()
• Patient Navigation (Behavioral Intervention)
• Questionnaire Administration ()

Trial Overview The study tests if providing free fecal immunochemical testing (FIT), educational materials on colorectal screening, and patient navigation can improve cancer screening rates in these communities.

Participant Groups

Group I: Screening (FIT, education, questionnaire, patient navigation) Experimental Treatment 4 Interventions

Participants receive free FIT tests in conjunction with education on colorectal cancer screening. Participants undergo self-collect FIT and mail the sample to Mayo Clinic Lab for processing. Participants also complete a questionnaire about colorectal cancer screening and healthcare. Participants receive FIT test results through Mayo Clinic nursing support and participants with a positive test are followed up by a patient navigator to discuss next steps and consultation with a gastroenterologist to review their results.

Fecal Immunochemical Test is already approved in United States, European Union, Canada, Japan, Australia for the following indications:

🇺🇸 Approved in United States as Fecal Immunochemical Test (FIT) for:

• Colorectal cancer screening

🇪🇺 Approved in European Union as Fecal Immunochemical Test (FIT) for:

• Colorectal cancer screening

🇨🇦 Approved in Canada as Fecal Immunochemical Test (FIT) for:

• Colorectal cancer screening

🇯🇵 Approved in Japan as Fecal Immunochemical Test (FIT) for:

• Colorectal cancer screening

🇦🇺 Approved in Australia as Fecal Immunochemical Test (FIT) for:

• Colorectal cancer screening

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mayo Clinic in Arizona Scottsdale, AZ

Who Is Running the Clinical Trial?

Mayo Clinic Lead Sponsor

National Cancer Institute (NCI) Collaborator

References

1. England pubmed.ncbi.nlm.nih.gov

Improving colorectal cancer screening in rural primary care: Preliminary effectiveness and implementation of a collaborative mailed fecal immunochemical test pilot. [2023] Mailed fecal immunochemical test (FIT) outreach can improve colorectal cancer (CRC) screening rates. We piloted a collaborative mailed FIT program with health plans and rural clinics to evaluate preliminary effectiveness and refine implementation strategies.

2. Greece pubmed.ncbi.nlm.nih.gov

Clinical impact of the immunochemical fecal occult blood test for colorectal cancer screening in Brazil. [2020] Colorectal cancer (CRC) screening programs based on the fecal occult blood test (FOBT) reduce CRC mortality. We carried out an observational prospective study to determine the accuracy of immunochemical FOBTs for the detection of CRC in individuals at average risk for the disease.

3. Australia pubmed.ncbi.nlm.nih.gov

Comparison of the performance of guaiac-based and two immunochemical fecal occult blood tests for identifying advanced colorectal neoplasia in Taiwan. [2019] We aimed to evaluate the performance of fecal occult blood tests (FOBT) for the screening of colorectal cancer (CRC).

4. England pubmed.ncbi.nlm.nih.gov

The Impact of Transitioning From Guaiac-Fecal Occult Blood Testing to Fecal Immunochemical Testing in a Canadian Colon Cancer Screening Program. [2022] To determine the impact of transitioning from guaiac-based fecal occult blood testing (gFOBT) to fecal immunochemical testing (FIT) on the detection rate of adenomas, advanced adenomas (AA) and colorectal cancer (CRC).

5. United States pubmed.ncbi.nlm.nih.gov

Guaiac versus immunochemical tests: faecal occult blood test screening for colorectal cancer in a rural community. [2019] To describe patient participation and clinical performance in a colorectal cancer (CRC) screening program utilising faecal occult blood test (FOBT).

6. United States pubmed.ncbi.nlm.nih.gov

Impact of Screening Program on Incidence of Colorectal Cancer: A Cohort Study in Italy. [2022] Colorectal cancer (CRC) screening using the fecal occult blood test (FOBT) has been shown to be effective in reducing cause-specific mortality. However, although it detects pre-cancerous adenomas, it is uncertain whether FOBT reduces the incidence of invasive cancer. The objective is to evaluate the impact of screening with immunochemical FOBT (FIT) on CRC incidence and mortality.

7. United States pubmed.ncbi.nlm.nih.gov

Recommendations on Fecal Immunochemical Testing to Screen for Colorectal Neoplasia: A Consensus Statement by the US Multi-Society Task Force on Colorectal Cancer. [2022] The use of the fecal occult blood test (FOBT) for colorectal cancer (CRC) screening is supported by randomized trials demonstrating effectiveness in cancer prevention and widely recommended by guidelines for this purpose. The fecal immunochemical test (FIT), as a direct measure of human hemoglobin in stool has a number of advantages relative to conventional FOBT and is increasingly used relative to that test. This review summarizes current evidence for FIT in colorectal neoplasia detection and the comparative effectiveness of FIT relative to other commonly used CRC screening modalities. Based on evidence, guidance statements on FIT application were developed and quality metrics for program implementation proposed.

8. United States pubmed.ncbi.nlm.nih.gov

Recommendations on Fecal Immunochemical Testing to Screen for Colorectal Neoplasia: A Consensus Statement by the US Multi-Society Task Force on Colorectal Cancer. [2022] The use of the fecal occult blood test (FOBT) for colorectal cancer (CRC) screening is supported by randomized trials demonstrating effectiveness in cancer prevention and widely recommended by guidelines for this purpose. The fecal immunochemical test (FIT), as a direct measure of human hemoglobin in stool has a number of advantages relative to conventional FOBT and is increasingly used relative to that test. This review summarizes current evidence for FIT in colorectal neoplasia detection and the comparative effectiveness of FIT relative to other commonly used CRC screening modalities. Based on evidence, guidance statements on FIT application were developed and quality metrics for program implementation proposed.

9. United States pubmed.ncbi.nlm.nih.gov

A national survey of primary care physicians' methods for screening for fecal occult blood. [2022] Screening with the fecal occult blood test (FOBT) has been shown to reduce colorectal cancer incidence and mortality in randomized, controlled trials. Although the test is simple, implementation requires adherence to specific techniques of testing and follow-up of abnormal results.

10. United States pubmed.ncbi.nlm.nih.gov

Comparison of Program Resources Required for Colonoscopy and Fecal Screening: Findings From 5 Years of the Colorectal Cancer Control Program. [2022] Colonoscopy and guaiac fecal occult blood tests and fecal immunochemical tests (FOBT/FIT) are the most common colorectal cancer screening methods in the United States. However, information is limited on the program resources required over time to use these tests.

11. United States pubmed.ncbi.nlm.nih.gov

Fecal occult blood testing beliefs and practices of U.S. primary care physicians: serious deviations from evidence-based recommendations. [2021] Fecal occult blood testing (FOBT) is an important option for colorectal cancer screening that should be available in order to achieve high population screening coverage. However, results from a national survey of clinical practice in 1999-2000 indicated that many primary care physicians used inadequate methods to implement FOBT screening and follow-up.