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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to boost screening rates for colorectal cancer (CRC) among low-income and ethnic minority groups. It focuses on a simple test called FIT (Fecal Immunochemical Test), which checks for blood in the stool and can help catch CRC early when it's easier to treat. Participants may receive educational support, feedback, and text reminders to encourage screening. Individuals between 50 and 75 years old who have visited a clinic at least once in the past two years might be a good fit for this trial. As an unphased study, this trial offers a unique opportunity to contribute to important research that could improve CRC screening for underserved communities.

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 colorectal cancer screening program is safe?

Research shows that the treatments in this trial are generally safe. One main tool is the fecal immunochemical test (FIT), often recommended for colorectal cancer screening. This test detects hidden blood in stool, an early cancer indicator. Studies have found that FIT is easy to use and widely accepted.

Educational programs, such as patient navigation, have undergone extensive research. These programs guide participants through the screening process and have proven effective without causing major issues.

Text message reminders also play a role in this trial. Research supports using text messages to remind and encourage participants to complete their screenings. This method is safe, focusing solely on communication rather than a medical procedure.

Overall, these treatments have been tested in numerous studies and are considered safe, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a comprehensive approach to improving colorectal cancer screening, which is crucial for early detection. Unlike the standard care that typically involves routine screening methods and occasional reminders, this trial integrates several innovative strategies such as text message reminders and culturally tailored instructions with the Fecal Immunochemical Test (FIT). The use of electronic health records for real-time feedback and point-of-care clinical decision support tools for physicians makes this approach more personalized and potentially more effective. By enhancing patient engagement and provider support, researchers hope to significantly increase screening rates and, ultimately, early cancer detection.

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

Research shows that fecal immunochemical tests (FIT), used in this trial, effectively screen for colorectal cancer (CRC). Studies have found that FIT detects the disease early and is as reliable as more invasive procedures like colonoscopies. In this trial, Group I participants will receive educational interventions, feedback, consultation, a FIT kit with culturally tailored instructions, and text message reminders. Programs that guide patients and use culturally relevant communication significantly increase screening rates. For instance, patient navigation programs have improved CRC screening rates by over 7 percentage points compared to standard care. Additionally, text message reminders help people remember to complete their tests, increasing participation. These combined strategies aim to catch colorectal cancer early, making it easier to treat and reducing cancer-related deaths. ^{1 4 6 7 8}

Who Is on the Research Team?

Roshan Bastani

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7573022/

Effectiveness of Patient Navigation to Increase Cancer ...

This study evaluates the effectiveness of patient navigation to increase screening for colorectal, breast, and cervical cancer in populations adversely ...

2.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2831644

Mailed Outreach and Patient Navigation for Colorectal ...

A mailed FIT outreach and patient navigation program led to a significant 7.3–percentage point increase in colorectal cancer (CRC) screening over usual care.

3.

academic.oup.com

academic.oup.com/jnci/article/115/6/680/7050938

Characteristics of patient navigation programs in the Cancer ...

Patient navigation is an evidence-based intervention that has been shown to substantially improve rates of colorectal cancer (CRC) screening and ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03200366

Comparing Interventions to Increase Colorectal Cancer ...

The purpose of this study is to compare two health system-based interventions, with one another and with usual care, to increase completion rates among a ...

5.

ebccp.cancercontrol.cancer.gov

ebccp.cancercontrol.cancer.gov/programDetails.do?programId=27435365

New Hampshire Colorectal Cancer Screening Program ...

Key Findings. Patients in the intervention group had a higher rate of colonoscopy screening compared with those in the usual care group (96.2% ...

6.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT01141114

Study of Patient Navigation to Promote Colon Cancer ...

This study will investigate whether patient navigation can increase rates of colorectal cancer screening among linguistically and culturally diverse ...

7.

thecommunityguide.org

thecommunityguide.org/findings/cancer-screening-patient-navigation-services-to-increase-colorectal-cancer-screening.html

Colorectal Cancer Screening: Patient Navigation

Patient navigation services provided through healthcare systems help patients overcome barriers to accessing colorectal cancer screening.

8.

formative.jmir.org

formative.jmir.org/2024/1/e53224

The Development of a Digital Patient Navigation Tool to ...

Our study team hypothesized that the eNav intervention will help improve CRC screening uptake among patients treated at FQHCs. The first step in ...