Colorectal Cancer Screening Program for Colorectal Cancer

Overseen By Roshan Bastani

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jonsson Comprehensive Cancer Center

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

Compensation: Varies

Number of Visits: Unknown

9745 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial implements research strategies to increase colorectal cancer (CRC) screening rates among low income and ethnic minority groups. CRC is the second most common cause of cancer mortality in the United States and disproportionately burdens low income and ethnic minority groups. Fecal immunochemical testing (FIT) is a test to check for blood in the stool. A brush is used to collect water drops from around the surface of a stool while it is still in the toilet bowl. The samples are then sent to a laboratory, where they are checked for a human blood protein. Blood in the stool may be a sign of colorectal cancer. Despite its potential for reducing CRC incidence and mortality, screening remains woefully underutilized. There is an unmet need for practical and effective programs to improve CRC screening rates. By implementing a culturally-tailored screening CRC program that supports providers and clinic staff to encourage eligible patients to complete FIT, researchers hope to reduce cancer disparities among low-income and ethnic groups and increase the CRC screening rate, which will help providers find CRC sooner, when it may be easier to treat.

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 this treatment for colorectal cancer screening?

Research shows that patient navigation programs, which guide patients through the healthcare process, can significantly increase colorectal cancer screening rates and follow-up procedures like colonoscopies, especially in underserved populations. ^{1 2 3 4 5}

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

The fecal occult blood test (FOBT) is a commonly recommended and safe screening method for detecting colorectal cancer, as it is non-invasive and involves analyzing a stool sample for hidden blood. ^{6 7 8 9 10}

How does the colorectal cancer screening program differ from other treatments for colorectal cancer?

The colorectal cancer screening program primarily uses fecal occult blood testing (FOBT), which is a non-invasive and cost-effective method to detect early signs of cancer by checking for hidden blood in stool samples. This approach is unique because it allows for early detection without the need for more invasive procedures like colonoscopy, although positive results from FOBT may require further investigation. ^{6 8 11 12 13}

Research Team

Roshan Bastani

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Eligibility Criteria

This trial is for low-income and ethnic minority individuals aged 50-75 who have visited a clinic at least once in the past two years. It aims to increase colorectal cancer screening rates within these groups.

Inclusion Criteria

I am between 50 and 75 years old.

I have visited a clinic at least once in the past two years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Clinic sites are randomized to either receive ongoing training, education, and feedback on CRC screening or provide usual care. Patients receive CRC screening recommendations, a FIT kit, and text message reminders.

Up to 3 years

Follow-up

Participants are monitored for CRC screening rates and return rates of completed FIT kits.

Up to 3 years

Treatment Details

Interventions

• Best Practice
• Consultation
• Educational Intervention
• Electronic Health Record Review
• Fecal Immunochemical Test
• Feedback
• Health Education
• Support Education Activity
• Text Message-Based Navigation Intervention

Trial Overview The study tests a culturally-tailored program that includes educational interventions, text message reminders, feedback, and fecal immunochemical testing (FIT) to improve colorectal cancer screening among eligible patients.

Participant Groups

Group I: Group I (education, feedback, consult, FIT kit, text message) Experimental Treatment 8 Interventions

Physicians and clinic staff receive ongoing training, education, and feedback on CRC screening, and utilize point-of-care clinical decision support tool throughout the trial. Patients receive CRC screening recommendations from provider, a FIT kit with culturally tailored instructions, consultation with clinic staff, and text message reminders throughout the trial.

Group II: Arm II (usual care) Active Control 2 Interventions

Physicians and clinic staff provide and patients receive CRC screening usual care throughout the trial.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

Tobacco Related Disease Research Program

Collaborator

Trials

27

Recruited

26,300+

Findings from Research

The patient navigation program in France significantly increased colorectal cancer screening participation by 3.3%, with a notable effect among affluent individuals (+4.1%) compared to deprived individuals (+2.6%).

While the program was more effective for affluent participants, it highlighted increased social inequalities in screening adherence when applied broadly; thus, it is recommended to focus navigation efforts on deprived populations, even though this approach may incur higher costs per additional individual screened.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness Analysis of a Navigation Program for Colorectal Cancer Screening to Reduce Social Health Inequalities: A French Cluster Randomized Controlled Trial. De Mil, R., Guillaume, E., Guittet, L., et al.[2018]

The implementation of a patient navigation (PN) program at five hospitals significantly increased the rate of follow-up colonoscopies after abnormal fecal immunochemical testing (FIT), from 40.6% in 2017 to 46% in 2018, indicating improved patient adherence to necessary screenings.

The average time from an abnormal FIT result to colonoscopy decreased from 163 days in 2017 to 113 days in 2018, demonstrating that the PN program effectively expedited the follow-up process for patients aged 50-75.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging the Gap: Patient Navigation Increases Colonoscopy Follow-up After Abnormal FIT. Idos, GE., Bonner, JD., Haghighat, S., et al.[2023]

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

Personal navigation increases colorectal cancer screening uptake. [2022]

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

Strategies to improve repeat fecal occult blood testing cancer screening. [2021]

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

Cost-Effectiveness Analysis of a Navigation Program for Colorectal Cancer Screening to Reduce Social Health Inequalities: A French Cluster Randomized Controlled Trial. [2018]

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

Bridging the Gap: Patient Navigation Increases Colonoscopy Follow-up After Abnormal FIT. [2023]

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

Refining the Patient Navigation Role in a Colorectal Cancer Screening Program: Results From an Intervention Study. [2022]

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

Screening for colorectal cancer in Chinese: comparison of fecal occult blood test, flexible sigmoidoscopy, and colonoscopy. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Diagnostic colonoscopy following a positive fecal occult blood test in community health center patients. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Strategies for increasing participation in mail-out colorectal cancer screening programs: a systematic review and meta-analysis. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Comparison of screen-detected and interval colorectal cancers in the Bowel Cancer Screening Programme. [2021]

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

Goals of screening. [2019]

11. Japan pubmed.ncbi.nlm.nih.gov

Characteristics of Advanced Colorectal Cancer Detected by Fecal Immunochemical Test Screening in Participants with a Negative Result the Previous Year. [2022]

12. 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]

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

Screening for colorectal cancer: the cost to find an advanced adenoma. [2015]