Education and Screening for Hepatitis C and Colorectal Cancer

(MATCHES Trial)

Overseen By Shannon Christy, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: Colorectal cancer, Hepatitis C, others

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

Compensation: Varies

Number of Visits: Unknown

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to promote screening for colorectal cancer and hepatitis C among patients at certain health clinics. Participants will receive educational materials, free stool-based tests for colorectal cancer, and free hepatitis C antibody testing. The trial targets individuals aged 45-75 who have not recently undergone a colonoscopy or hepatitis C screening and have no history of colorectal cancer or current symptoms. Participants should be able to read and understand English or Spanish and be willing to complete surveys or interviews. As an unphased trial, this study offers a unique opportunity to contribute to important public health research and potentially improve screening practices.

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 the MATCHES intervention is safe for patients?

Research has shown that the MATCHES program focuses on educating people and screening for hepatitis C (HCV) and colorectal cancer (CRC). It provides information and tests, which are generally safe.

No reports of negative effects have emerged from the educational materials or screening tests used in the MATCHES program. The tests include a stool test for CRC and a blood test for HCV, both easy to perform and generally comfortable for patients.

Studies on HCV have found that patients who received treatment for their infection had a lower risk of developing colon cancer compared to those who did not receive treatment. This suggests the program could be beneficial. The safety of these tests and educational materials is well-established, with no significant risks reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MATCHES intervention because it combines education with proactive screening for both colorectal cancer (CRC) and hepatitis C (HCV), targeting these issues simultaneously. Unlike standard treatments that focus on one condition at a time, MATCHES offers a comprehensive approach by providing patients with educational booklets in English or Spanish, free stool-based CRC screening, and free HCV antibody testing. This multi-pronged strategy not only raises awareness but also improves access to preventative care, potentially increasing early detection rates and improving overall health outcomes.

What evidence suggests that the MATCHES intervention is effective for promoting HCV and CRC screening?

Research has shown that education and free screening significantly increase the number of people getting checked for colorectal cancer (CRC) and Hepatitis C Virus (HCV). In this trial, participants will receive the MATCHES intervention, which includes education and free screening. One study found that stool tests reduced new CRC cases by 25%, indicating that testing stool samples can help find cancer early. For HCV, combining education with free testing raises awareness and encourages testing. Both approaches aim to detect diseases early, which is crucial for effective treatment and better health outcomes. ^{6 7 8 9 10}

Who Is on the Research Team?

Shannon Christy, PhD

Principal Investigator

Moffitt Cancer Center

Clement K Gwede, PhD, MPH, RN, FAAN

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

The MATCHES trial is for English or Spanish-speaking individuals aged 45-75 who have never been screened for Hepatitis C Virus (HCV), are at average risk for colorectal cancer (CRC), and aren't up to date with CRC screening. They must be willing to complete surveys, interviews via phone or video call, and provide informed consent. Those with a personal history of CRC, current symptoms, or not receiving care at participating clinics are excluded.

Inclusion Criteria

I am willing to do an interview over the phone or on a video call.

I can read, write, and understand English or Spanish.

I am willing and able to complete surveys and receive the intervention.

Exclusion Criteria

Participants that do not meet all Inclusion Eligibility requirements will be excluded

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education and Initial Screening

Participants receive education about CRC and HCV and access to free stool-based CRC screening and HCV antibody testing

12 months

Multiple visits as needed for education and screening

Follow-up

Participants are monitored for screening uptake and completion of CRC and HCV screenings

Up to 41 months

What Are the Treatments Tested in This Trial?

Interventions

• MATCHES

Trial Overview MATCHES is testing an educational intervention designed to encourage simultaneous screening for HCV and CRC in patients attending Federally Qualified Health Centers (FQHCs). The study involves providing materials, completing surveys, and possibly participating in remote interviews.

How Is the Trial Designed?

Group I: Multilevel Action Toward Colorectal Cancer and Hepatitis C Education and Screening (MATCHES) Experimental Treatment 1 Intervention

The MATCHES intervention includes three patient-level intervention strategies that will be rolled out in two waves. Patient-level strategies are: 1) a combined education booklet with information about CRC/CRC screening and HCV infections/liver cancer/HCV screening in English or Spanish, 2) access to free stool-based CRC screening, and 3) access to free HCV antibody testing.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Florida Biomedical Research Program - Bankhead Coley

Collaborator

Trials

1

Recruited

350+

Published Research Related to This Trial

A study analyzing data from 6890 colorectal cancer patients in New South Wales found significant variations in care processes across 105 hospitals, particularly affecting older adults who were less likely to receive timely treatment and multidisciplinary discussions.

Patient characteristics, such as age, disease extent, and comorbidity scores, were strongly linked to poorer outcomes, suggesting that these factors should be considered when comparing hospital performance and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of variation in colorectal cancer care and outcomes in New South Wales: a population-based health data linkage study. Jorgensen, ML., Young, JM., Dobbins, TA., et al.[2019]

An electronic primer message sent through a patient portal significantly increased colorectal cancer (CRC) screening completion rates from 32.1% to 37.6% in a study of 2339 average-risk patients aged 50 to 75 years.

Patients who opened the electronic primer message had a 7.3% higher screening completion rate, and the time to complete screening was also shorter in the intervention group, indicating that digital reminders can effectively enhance participation in CRC screening programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Patient Portal Messaging Before Mailing Fecal Immunochemical Test Kit on Colorectal Cancer Screening Rates: A Randomized Clinical Trial. Goshgarian, G., Sorourdi, C., May, FP., et al.[2022]

In a 3-year study involving 33,606 patients at a Central Texas Federally Qualified Health Center, 19.9% completed a mailed stool test for colorectal cancer screening, demonstrating the effectiveness of this outreach method.

The program showed significant equity in screening uptake, with Hispanic/Latinx and Spanish-speaking patients participating more than their white and English-speaking counterparts, and Spanish speakers also had higher rates of completing follow-up colonoscopies after positive test results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Equitable Implementation of Mailed Stool Test-Based Colorectal Cancer Screening and Patient Navigation in a Safety Net Health System. Scott, RE., Chang, P., Kluz, N., et al.[2023]

In a safety-net healthcare system, a mailed outreach program significantly improved colorectal cancer screening completion, with 46.2% of patients completing screening, primarily through mailed invitations.

Despite the success in initial screening, only 50.5% of patients with a positive FIT completed the necessary diagnostic colonoscopy within 6 months, indicating a need for better follow-up strategies to ensure comprehensive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colorectal Cancer Screening and Yield in a Mailed Outreach Program in a Safety-Net Healthcare System. Murphy, CC., Halm, EA., Zaki, T., et al.[2022]

The implementation of a hepatitis C screening reminder in the Epic Electronic Health Record significantly increased the number of completed antibody tests from 733 to 6502 over a two-year period.

Despite the increase in screening, the rate of positive hepatitis C tests decreased from 5.9% to 2.0%, suggesting that while more people were tested, fewer were found to be infected, indicating effective outreach and education efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic Health Record Reminder Effect on Hepatitis C Antibody Screening. Mulhem, E., Brown, I., Song, K.[2021]

New direct-acting antivirals for chronic hepatitis C have significantly improved cure rates, achieving up to 96% compared to previous treatments with interferon and ribavirin, which had low success and high side effects.

Updated national screening guidelines recommend one-time screening for individuals born between 1945 and 1965, which, along with timely treatment, can enhance public health outcomes and lower healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healing livers, saving lives: Hepatitis C screening in an era of cure. Boucher, CM., Walsh, A., Forest, CP.[2018]

A multifaceted intervention significantly increased Hepatitis C virus (HCV) screening rates from 10.1% to 34.6% among eligible baby boomers in a large safety-net health system, highlighting its effectiveness in improving screening uptake.

The intervention particularly benefited older patients and those with more engagement in primary care, suggesting that targeted strategies can enhance screening among high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Multifaceted Intervention to Reduce Health Disparities in Hepatitis C Screening: A Pre-Post Analysis. Jain, MK., Rich, NE., Ahn, C., et al.[2020]

The implementation of an electronic medical record (EMR) reminder system significantly increased HCV screening rates from 12% to 37% among primary care patients, indicating that reminders can effectively promote testing.

However, the yield of positive HCV tests decreased from 7% to 1.6% after the reminder system was introduced, suggesting that the screening was extended to a lower-risk population, while patients with a history of abnormal liver tests had a much higher positivity rate of 6.7%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of electronic reminder systems on hepatitis C screening in primary care. MacLean, CD., Berger, C., Cangiano, ML., et al.[2018]

Colorectal cancer (CRC) and hepatitis B screening rates are notably low among Vietnamese Americans, influenced by factors such as sociodemographics, knowledge, cultural beliefs, and access to healthcare providers.

Promising strategies to improve screening rates include using public media education combined with healthcare provider involvement and culturally tailored interventions led by Vietnamese lay advisors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contributing factors to colorectal cancer and hepatitis B screening among Vietnamese Americans. Nguyen-Truong, CK., Lee-Lin, F., Gedaly-Duff, V.[2022]

In a survey of 2000 residents aged 50 and older in Brooklyn, only 31% identified colonoscopy as the best screening test for colorectal cancer, highlighting a gap in awareness.

The main barriers to undergoing colonoscopy included fear of pain and discomfort, as well as difficulties with bowel preparation, suggesting that improving patient education and the screening process could enhance participation rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers to screening colonoscopy in an urban population: a study to help focus further efforts to attain full compliance. Ghevariya, V., Duddempudi, S., Ghevariya, N., et al.[2022]

Both primary care physicians (PCPs) and average-risk adults recognize lack of awareness and physician recommendations as major barriers to colorectal cancer (CRC) screening, highlighting a communication gap in healthcare.

Only 10% of adults who had seen a doctor in the past year received a recommendation for CRC screening, indicating a need for improved strategies to encourage healthcare providers to discuss screening with eligible patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers to colorectal cancer screening: a comparison of reports from primary care physicians and average-risk adults. Klabunde, CN., Vernon, SW., Nadel, MR., et al.[2019]

Colorectal cancer (CRC) and hepatocellular carcinoma (HCC) significantly impact underserved populations in the USA, with low screening rates contributing to higher incidence and mortality in these groups.

The review suggests that improving screening strategies and implementing targeted research and policy solutions could help reduce the burden of CRC and HCC among racial/ethnic minorities and individuals with low socioeconomic status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How can we boost colorectal and hepatocellular cancer screening among underserved populations? Goebel, M., Singal, AG., Nodora, J., et al.[2021]

A study involving 894 participants (413 who had previously participated in FOBT screening and 481 who had not) identified key psychosocial factors influencing colorectal cancer screening uptake, including faecal aversion and beliefs about the value of screening.

Demographic factors such as age (specifically those aged 65-69) and the type of FOBT test used also significantly impacted participation rates, suggesting that targeted interventions could help increase screening participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial variables associated with colorectal cancer screening in South Australia. Cole, SR., Zajac, I., Gregory, T., et al.[2022]

Mailed reminders to patients significantly increased colorectal cancer screening rates from 38.1% to 44.0%, especially among older age groups, indicating that targeted communication can effectively promote screening.

While electronic reminders for physicians did not show a significant overall increase in screening rates, they appeared to be beneficial for patients with frequent primary care visits, suggesting that tailored approaches may enhance screening efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and physician reminders to promote colorectal cancer screening: a randomized controlled trial. Sequist, TD., Zaslavsky, AM., Marshall, R., et al.[2022]

Out of 269 clients screened for hepatitis C, a significant number received vaccinations for hepatitis A (78.9%) and B (84.9%), indicating effective follow-up care after screening.

While 51.2% of clients reported adverse effects related to their positive anti-HCV status, such as difficulties in obtaining health insurance, 86.0% expressed satisfaction with their decision to get tested, suggesting that screening can lead to positive health behaviors despite some challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits and adverse effects of hepatitis C screening: early results of a screening program. Trepka, MJ., Zhang, G., Leguen, F., et al.[2019]

Citations

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2. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2835051

Long-Term Effectiveness Associated With Fecal ... The results showed a statistically significant 25% reduction in CRC incidence (aRR, 0.75; 95% CI, 0.72-0.77) and a 34% reduction in CRC ...

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Factors associated with prior completion of colorectal cancer ... To examine psychosocial factors associated with completion of CRC and HCV screenings in order to inform a multi-behavioral educational intervention.

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Digital health interventions for colorectal cancer screening ... This scoping review examines how individual, contextual, technological, and timing-related factors shape CRC screening outcomes in DHI-based trials. Following ...

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Patients With Chronic Hepatitis C Virus Infection Are at an ... Our findings suggested that patients with chronic HCV infection are at an elevated risk of developing CRC.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1533002824000823

Different Metabolic Associations of Hepatitis C With Colon ... The HCV-untreated cohort had the highest cumulative incidence of CC (0.883%; 0.371-1.839%), while HCV-treated (0.478%; 0.110-1.518%) and HCV-uninfected cohorts ...

8. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/563997

Multilevel Action Toward Colorectal Cancer and Hepatitis C ... The MATCHES intervention includes three patient-level intervention strategies that will be rolled out in two waves. Patient-level strategies are: 1) a combined ...

9. infectiousdiseaseadvisor.com infectiousdiseaseadvisor.com/news/hepatitis-c-infection-may-increase-colon-cancer-risk-but-not-rectal-cancer-risk/

Hepatitis C Infection May Increase Colon Cancer Risk, But ... Hepatitis C infection and age 49 years and older is linked to a higher risk of developing colorectal cancer.

10. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-10496

Strategies to Promote Colorectal Cancer and Hepatitis C ... MATCHES may increase CRC and HCV screening and reduce CRC and liver cancer mortality among patients aged 45-75. Eligibility Criteria ...