Colorectal Cancer Screening Program for Underserved Communities

Overseen By Clinical Trials Referral Office

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

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}

Research Team

Juliana M. Kling, MD, MPH

Principal Investigator

Mayo Clinic

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

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
• 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.

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 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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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

Clinical impact of the immunochemical fecal occult blood test for colorectal cancer screening in Brazil. [2020]

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]

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]

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]

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

Impact of Screening Program on Incidence of Colorectal Cancer: A Cohort Study in Italy. [2022]

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]

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]

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

A national survey of primary care physicians' methods for screening for fecal occult blood. [2022]

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]

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]