Colorectal Cancer Screening Program for Underserved Communities

Overseen By Yahaira J. Parker

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Colorectal cancer, Colon polyps, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to address differences in colorectal cancer prevention and screening among Black and underserved communities in the Phoenix area. The goal is to reduce high rates of colorectal cancer in these communities by providing free home-based stool tests, education, and follow-up care. Participants will receive a fecal immunochemical test, which can detect signs of cancer, and guidance on next steps if results are positive. Ideal candidates are those aged 45 or older from predominantly African American churches in Phoenix, without a history of colorectal cancer or recent screening tests. This unphased trial offers a unique opportunity to contribute to important research that could improve community health outcomes.

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 this screening program is safe for participants?

Research has shown that the fecal immunochemical test (FIT) is a well-accepted method for screening colorectal cancer. FIT detects hidden blood in stool, which can indicate cancer. Studies have found that FIT is safe and effective for many individuals.

No major safety issues have been reported with FIT. As a non-invasive test, it does not involve entering the body, making it more comfortable than other screening methods. This test has been widely used without significant side effects.

In summary, based on research and its common use in medical practice, FIT is considered a safe option for colorectal cancer screening. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it targets colorectal cancer screening in underserved communities using a unique approach. Unlike traditional methods that often require in-person visits and invasive procedures like colonoscopies, this trial uses the Fecal Immunochemical Test (FIT), which participants can do at home. The FIT is non-invasive, easy to use, and involves collecting a stool sample and mailing it to a lab for analysis. This makes screening more accessible, especially for those who might have difficulty accessing healthcare facilities. Additionally, the trial includes education and patient navigation, which can help increase awareness and ensure follow-up care, potentially improving early detection rates.

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

Research shows that the fecal immunochemical test (FIT), which participants in this trial will receive, effectively screens for colorectal cancer. Studies have found that FIT can detect early signs of this cancer by identifying hidden blood in stool samples. In a large study involving over 263,000 people, regular FIT screening starting between ages 40 to 49 reduced the risk of developing colorectal cancer. FIT is popular because it is easy to use and doesn't require invasive procedures. This test helps catch cancer early, which is crucial for better treatment outcomes. ^{6 7 8 9 10}

Who Is on the Research Team?

Juliana M. Kling, MD, MPH

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Educational Intervention
• Fecal Immunochemical Test
• Patient Navigation
• 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.

How Is the Trial Designed?

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 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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The fecal immunochemical test (FIT) is increasingly favored over the traditional fecal occult blood test (FOBT) for colorectal cancer screening due to its direct measurement of human hemoglobin in stool, which enhances its effectiveness in detecting colorectal neoplasia.

Current evidence supports the use of FIT as a reliable screening method for colorectal cancer, leading to the development of guidance statements and quality metrics for its implementation in screening programs.

NCBI (Pubmed)

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. Robertson, DJ., Lee, JK., Boland, CR., et al.[2022]

Colorectal cancer screening programs incur significant costs beyond just the clinical expenses of tests, with the total cost per person decreasing from $3,962 in the first year to $1,714 in subsequent years, indicating potential for cost savings over time.

Programs using colonoscopy had a higher average clinical cost per person ($1,369) compared to those using FOBT/FIT ($280), suggesting that less expensive screening methods could be more cost-effective for larger populations.

NCBI (Pubmed)

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. Subramanian, S., Tangka, FKL., Hoover, S., et al.[2022]

The fecal immunochemical test (FIT) is increasingly favored over the traditional fecal occult blood test (FOBT) for colorectal cancer screening due to its direct measurement of human hemoglobin in stool, which enhances its effectiveness in detecting colorectal neoplasia.

Current evidence supports the use of FIT as a reliable screening method, leading to the development of guidance statements and quality metrics for its implementation in colorectal cancer prevention programs.

NCBI (Pubmed)

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. Robertson, DJ., Lee, JK., Boland, CR., et al.[2022]

A national survey of 1,134 primary care physicians revealed that most still rely on standard guaiac tests for fecal occult blood testing (FOBT), with only 22% using higher sensitivity tests and just 9% using immunochemical tests, indicating a need for improved screening methods.

While follow-up practices have improved, with fewer physicians recommending inappropriate tests after a positive result, many still do not use reminder systems to ensure patients complete home tests, highlighting gaps in FOBT implementation and follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal occult blood testing beliefs and practices of U.S. primary care physicians: serious deviations from evidence-based recommendations. Nadel, MR., Berkowitz, Z., Klabunde, CN., et al.[2021]

In a study of 699 participants, quantitative immunochemical FOBT (qnFIT) demonstrated superior detection capabilities for advanced colorectal neoplasms (ACRN) compared to qualitative immunochemical FOBT (qlFIT) and guaiac-based FOBT (GT), with a sensitivity of 56.8% and an accuracy of 86.7%.

The optimal cut-off value for qnFIT to detect advanced colorectal neoplasms was established at 25 ng/mL, indicating that higher levels of fecal hemoglobin correlate with the presence of larger polyps and advanced adenomas.

NCBI (Pubmed)

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. Ou, CH., Kuo, FC., Hsu, WH., et al.[2019]

In a survey of 1147 primary care physicians and over 11,000 adults, it was found that 32.5% of physicians used less accurate in-office FOBT methods instead of recommended home tests, which could impact the effectiveness of colorectal cancer screening.

There was significant nonadherence to follow-up guidelines for positive FOBT results, with 29.7% of physicians recommending only a repeat FOBT instead of appropriate diagnostic procedures, potentially leading to missed opportunities for early cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A national survey of primary care physicians' methods for screening for fecal occult blood. Nadel, MR., Shapiro, JA., Klabunde, CN., et al.[2022]

A pilot study involving 169 Medicaid or Medicare enrollees showed that a collaborative mailed fecal immunochemical test (FIT) program led to a 37% completion rate for colorectal cancer screening, with 21% returning the mailed FIT within 3 months.

The program was found to be feasible and acceptable in rural clinics, supported by positive feedback on its benefits and alignment with existing workflows, indicating potential for broader implementation in similar settings.

NCBI (Pubmed)

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. Davis, MM., Coury, J., Larson, JH., et al.[2023]

The immunochemical fecal occult blood test (i-FOBT) demonstrated high compliance (91.2%) among 1,039 average-risk participants aged 50-75, making it a feasible option for colorectal cancer (CRC) screening.

The i-FOBT effectively detected advanced colorectal cancer in 12.3% of positive cases and identified a total CRC detection rate of 1.05% in the entire screened population, indicating its efficacy in identifying cancers and high-risk adenomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical impact of the immunochemical fecal occult blood test for colorectal cancer screening in Brazil. Teixeira, CR., Bonotto, ML., Lima, JP., et al.[2020]

Transitioning from guaiac-based fecal occult blood testing (gFOBT) to fecal immunochemical testing (FIT) significantly increased the detection rates of colorectal cancer (CRC), advanced adenomas (AA), and adenomas, with FIT detecting 67 CRC cases compared to 34 with gFOBT.

In a study involving 2816 patients referred for colonoscopy, FIT was associated with a 2.62 times higher adenoma detection rate and a 2.04 times higher rate for the composite outcome of AA and CRC, indicating its superior efficacy in screening for colorectal issues.

NCBI (Pubmed)

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. Sultanian, R., Du, L., Moysey, B., et al.[2022]

The study found that participation in colorectal cancer screening using faecal occult blood tests (FOBT) was 36.3%, with higher participation rates for the immunochemical kit compared to the guaiac kit (OR=1.9).

The immunochemical test also had a higher positivity rate (9.5%) compared to the guaiac test (3.9%), and both tests showed a high yield of neoplasia with low complication rates from follow-up colonoscopies (2-3%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guaiac versus immunochemical tests: faecal occult blood test screening for colorectal cancer in a rural community. Hughes, K., Leggett, B., Del Mar, C., et al.[2019]

A screening program using immunochemical fecal occult blood tests (FIT) in Northern Italy significantly reduced colorectal cancer (CRC) incidence and mortality, with a 10% decrease in cumulative incidence and a 27% decrease in incidence-based mortality over the study period.

Approximately 70% of the invited population participated in the screening, leading to the detection of 2896 cancers, which highlights the effectiveness of organized screening programs in early cancer detection and prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Screening Program on Incidence of Colorectal Cancer: A Cohort Study in Italy. Giorgi Rossi, P., Vicentini, M., Sacchettini, C., et al.[2022]

Citations

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Long-Term Effectiveness Associated With Fecal ... Findings In this cohort study including 263 125, fecal immunochemical test (FIT) screening initiated at age 40 to 49 years followed by screening ...

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Benefits of colorectal cancer screening using fecal ... Fecal immunochemical test (FIT) performance for colorectal cancer screening varies by age and sex, yet most FIT-based screening programs use uniform ...

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Fecal occult blood test A fecal occult blood test looks for blood in a sample of stool. It can find tiny amounts of blood that can't be seen just by looking at the stool.

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Fecal Immunochemical Tests (FIT) vs. Office-Based Guaiac ... Indeed, colonoscopic screening of everyone must be considered very carefully when a minority, only about. 4%–7%, will develop CRC. FECAL OCCULT BLOOD TEST. ( ...

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