FIT Kit Distribution Strategies for Colorectal Cancer Prevention

Recruiting at 1 trial location

Overseen By Jungyoon Kim, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska

Disqualifiers: Colorectal cancer, Adenomas, Inflammatory bowel, others

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

Compensation: Varies

Number of Visits: 1

1200 Participants Needed

Trial Summary

What is the purpose of this trial?

African Americans face racial disparities in colorectal cancer (CRC), with lower screening rates and higher incidence and mortality rates. To address this gap and improve CRC screening rates, investigators aims to recruit a total of 1,200 African American participants aged 45-75 during their visits to the DMV, 4606 N 56th St Ste100, Omaha, for CRC screening. All participants will receive a free Fecal Immunochemical Test (FIT) kit with a prepaid return envelope, a culturally tailored educational brochure, reminder text messages and calls, and post-FIT navigation support for participants with positive results or without family doctor/insurance. Kits are returned to a designated Nebraska Medicine lab for testing, and test results will be mailed to participants within 14-21 days. Participants will be assigned to one of two groups: the on-site distribution group or the on-site distribution group with social media advertising group. The social media advertising group will additionally be exposed to targeted ads on platforms like Facebook, Instagram, and YouTube to increase awareness and potentially improve participation rates. The study will compare FIT kit return rates, positive screening rates, and completion rates of follow-up colonoscopies after positive FIT results between the two groups.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on distributing and returning FIT kits for colorectal cancer screening.

What data supports the effectiveness of the treatment Mailed Fecal Immunochemical Test (FIT) Kit Distribution for colorectal cancer prevention?

Research shows that the fecal immunochemical test (FIT) is an effective tool for colorectal cancer screening, with advantages like requiring only one stool sample and having better sensitivity for detecting blood compared to older tests. Mailing FIT kits to patients, along with reminders, has been found to be a beneficial strategy for increasing screening rates in community health centers. ^{1 2 3 4 5}

Is the FIT Kit safe for humans?

The fecal immunochemical test (FIT) is widely used for colorectal cancer screening and is considered safe for humans. The research focuses on its effectiveness and performance, but there are no safety concerns mentioned in the studies. ^{1 2 3 5 6}

How does the FIT Kit Distribution treatment for colorectal cancer prevention differ from other treatments?

The FIT Kit Distribution treatment is unique because it involves mailing or providing on-site fecal immunochemical test kits, which are used to detect hidden blood in stool, a potential sign of colorectal cancer. This approach is more convenient and accessible compared to traditional methods, as it allows for home testing and requires only one stool sample, increasing participation in screening programs. ^{1 2 3 5 7}

Research Team

Jungyoon Kim, PhD

Principal Investigator

University of Nebraska

Eligibility Criteria

This trial is for African Americans aged 45-75 in Douglas County, NE who haven't kept up with colorectal cancer screenings. They must be able to communicate in English and provide contact info. People with a personal or family history of colorectal cancer, adenomas, or inflammatory bowel disease cannot join.

Inclusion Criteria

I am between 45 and 75 years old.

Ability to speak, read, and write English

I am not current with my colorectal cancer screenings.

Exclusion Criteria

My family has a history of colorectal cancer.

I have had colorectal cancer in the past.

I have had precancerous polyps or inflammatory bowel disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

3-6 months

Intervention

Participants receive FIT kits at DMV locations, with one group also receiving targeted social media advertisements

2.5 months

1 visit (in-person at DMV), ongoing virtual engagement

Follow-up

Participants are monitored for FIT kit return rates and follow-up colonoscopy completion after positive results

6 months

Treatment Details

Interventions

• Mailed Fecal Immunochemical Test (FIT) Kit Distribution
• On-site Fecal Immunochemical Test (FIT) Kit Distribution

Trial Overview The study compares two ways of giving out FIT kits for colorectal cancer screening: handing them directly to people at DMV locations versus mailing them. It aims to see which method gets more people screened and is more cost-effective.

Participant Groups

Group I: On-site Group Experimental Treatment 1 Intervention

The on-site distribution group will receive the Fecal Immunochemical Test (FIT) kits directly while visiting the Department of Motor Vehicles (DMV) location at 4606 N 56th St Suite 100, Omaha, NE 68104. Participants in the on-site group will be guided through the kit process by trained research staff present. They will be given instructions on collecting the stool sample and using the FIT kit properly. They will also be given a culturally tailored educational brochure, a prepaid return envelope, and receive reminder text messages and phone calls within 3 weeks of receipt of the FIT kit. Post-FIT navigation support will be provided for those with positive results or without a family doctor/insurance.

Group II: On-site Group With Social Media Advertising Active Control 1 Intervention

The onsite group with social media advertising participants will receive FIT kits directly at the Department of Motor Vehicles (DMV) location at 4606 N 56th St Suite 100, Omaha, NE 68104. Additionally, they will be exposed to targeted social media advertisements on Facebook, Instagram, and YouTube. These participants will encounter ads featuring video content with community member testimonials, emphasizing the importance of colorectal cancer screening for African Americans aged 45-75. The campaign will run from August 19 to October 29, 2024. Participants in this group will receive the FIT kits at the DMV along with detailed instructions on how to collect the stool sample and use the kit. They will also receive a culturally tailored educational brochure, prepaid return envelope, reminder text messages, and phone calls within three weeks of receipt of the FIT kit. Post-FIT navigation support will be provided for those with positive results or without a family doctor/insurance.

Mailed Fecal Immunochemical Test (FIT) Kit Distribution is already approved in United States, European Union, Canada, Japan, Brazil for the following indications:

Approved in United States as Fecal Immunochemical Test for:

• Colorectal Cancer Screening

Approved in European Union as Fecal Immunochemical Test for:

• Colorectal Cancer Screening

Approved in Canada as Fecal Immunochemical Test for:

• Colorectal Cancer Screening

Approved in Japan as Fecal Immunochemical Test for:

• Colorectal Cancer Screening

Approved in Brazil as Fecal Immunochemical Test for:

• Colorectal Cancer Screening

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

Robert Wood Johnson Foundation

Collaborator

Trials

161

Recruited

697,000+

Findings from Research

Fecal immunochemical testing (FIT) outreach significantly increased screening completion rates (42.4%) compared to point-of-care (POC) strategies (24.0%), indicating that mailing FIT kits and following up with reminders is more effective in encouraging patients to get screened for colorectal cancer.

Although FIT outreach is more effective, it is also more expensive ($30.43 per patient) compared to POC distribution ($4.93 per patient), which may pose challenges for community health centers under current payment models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outreach for Annual Colorectal Cancer Screening: A Budget Impact Analysis for Community Health Centers. Liss, DT., French, DD., Buchanan, DR., et al.[2016]

In a study of 56,980 average-risk individuals aged 50-74, 10.2% had an unsatisfactory fecal immunochemical test (FIT), primarily due to inadequate specimens and incomplete labeling.

Less than half (41%) of those with an unsatisfactory FIT completed a follow-up test within 15 months, indicating a need for improved patient education and support in screening programs to enhance colorectal cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unsatisfactory Fecal Immunochemical Tests for Colorectal Cancer Screening: Prevalence, Reasons, and Subsequent Testing. Liu, PH., Nair, RG., Skinner, CS., et al.[2023]

The fecal immunochemical test (FIT) is a highly sensitive tool for colorectal cancer screening, outperforming older guaiac tests by detecting hemoglobin more effectively, which allows for screening with just one stool sample per cycle.

FIT's growing use in both individual and programmatic settings highlights its potential for improving colorectal cancer detection and monitoring, making it a valuable option for public health initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal Immunochemical Test: The World's Colorectal Cancer Screening Test. Robertson, DJ., Selby, K.[2021]

Fecal immunochemical testing (FIT) is an effective screening method for colorectal cancer, but an abnormal result requires follow-up colonoscopy, which not all patients complete.

A new risk prediction model was successfully redeveloped for a specific health center, identifying patients unlikely to follow up on abnormal FIT results, although the original model did not recalibrate well in a different setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The recalibration and redevelopment of a model to calculate patients' probability of completing a colonoscopy following an abnormal fecal test. Petrik, AF., Johnson, ES., Slaughter, M., et al.[2023]

In a large-scale screening program involving over 1.9 million participants, the parallel use of fecal immunochemical test (FIT) and risk assessment (RA) achieved a sensitivity of 78% and a specificity of 78% for detecting colorectal cancer (CRC), indicating a balanced approach to screening.

The study found that while the combination of RA and FIT improved sensitivity for CRC detection compared to FIT alone, the overall effectiveness of FIT as a standalone initial screening test was limited, suggesting a need for optimization in risk assessment methods to enhance screening outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic accuracy of risk assessment and fecal immunochemical test in colorectal cancer screening: Results from a population-based program and meta-analysis. Wang, Z., Teng, J., Wu, W., et al.[2023]

In a study of 323,349 health plan members aged 50 to 70, annual fecal immunochemical test (FIT) screening demonstrated high sensitivity for detecting colorectal cancer (CRC), identifying 80.4% of CRC cases diagnosed within a year, with the highest detection rate in the first round (84.5%).

Participation in annual FIT screening was strong, with 48.2% of invited patients participating in the first round and 75.3% to 86.1% continuing in subsequent rounds, indicating that programmatic FIT screening is both feasible and effective for population-level CRC screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal Immunochemical Test Program Performance Over 4 Rounds of Annual Screening: A Retrospective Cohort Study. Jensen, CD., Corley, DA., Quinn, VP., et al.[2022]

The use of postal distribution of fecal immunochemical test (FIT) kits significantly increased colorectal cancer screening participation rates from 24.5% to 42.6%, and further to 51.4% with follow-up telephone reminders, demonstrating the effectiveness of this intervention in underserved regions of Korea.

Factors such as low educational attainment and poor previous participation in screening programs were linked to lower response rates, highlighting the need for targeted outreach to improve participation among these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increase in the Colorectal Cancer Screening Rate by a Round-Mailed Fecal Immunochemical Testing Kit and Associated Factors in Underserved Regions of Korea: A Community-Based Intervention Study. Hong, S., Shin, HY., Lee, B., et al.[2021]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Outreach for Annual Colorectal Cancer Screening: A Budget Impact Analysis for Community Health Centers. [2016]

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

Unsatisfactory Fecal Immunochemical Tests for Colorectal Cancer Screening: Prevalence, Reasons, and Subsequent Testing. [2023]

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

Fecal Immunochemical Test: The World's Colorectal Cancer Screening Test. [2021]

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

The recalibration and redevelopment of a model to calculate patients' probability of completing a colonoscopy following an abnormal fecal test. [2023]

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

Diagnostic accuracy of risk assessment and fecal immunochemical test in colorectal cancer screening: Results from a population-based program and meta-analysis. [2023]

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

Fecal Immunochemical Test Program Performance Over 4 Rounds of Annual Screening: A Retrospective Cohort Study. [2022]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Increase in the Colorectal Cancer Screening Rate by a Round-Mailed Fecal Immunochemical Testing Kit and Associated Factors in Underserved Regions of Korea: A Community-Based Intervention Study. [2021]