Colorectal Cancer Screening Intervention for Colorectal Cancer

(RISCC Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Inflammatory bowel disease, previous colorectal cancer, others

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?

The trial aims to improve colorectal cancer screening rates in rural Indiana through an evidence-based approach. Clinics will mail home test kits, send reminders, and use a Patient Navigator to guide eligible patients through the process. This applies to patients aged 45 to 75 who haven't had a colonoscopy in the past 10 years or a FIT (fecal immunochemical test) in the last year. The study will examine how these strategies affect screening rates and costs to determine their effectiveness and sustainability. As an unphased trial, it offers patients the chance to contribute to research that could enhance cancer screening accessibility and effectiveness in their 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 intervention is safe for improving colorectal cancer screening rates?

Studies have shown that the methods used in this trial for colorectal cancer screening are generally safe. Research has found that serious side effects, such as severe bleeding or a tear in the colon wall, occur rarely. Despite these risks, the benefits of screening make it worthwhile. Proper use can significantly reduce the number of colorectal cancer cases and deaths, making it an important tool for cancer prevention. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to enhance colorectal cancer screening rates by implementing an evidence-based intervention. Unlike traditional approaches that rely heavily on patient initiative, this strategy involves clinics being grouped into clusters and adopting a structured implementation period. This approach could lead to more systematic and widespread screening, potentially catching cancers earlier and improving outcomes. By examining how different clinics adopt and maintain these practices, the trial may uncover more effective ways to increase screening participation, ultimately aiming to shift the standard of care toward a more proactive model.

What evidence suggests that this intervention is effective for improving colorectal cancer screening rates?

This trial will evaluate the effectiveness of evidence-based interventions to boost colorectal cancer screening rates. Research has shown that proven methods, such as mailing FIT kits and providing patient guides, significantly increase screening rates. One study found that clinics using these methods achieved screening rates of 34.6%, compared to just 16.6% without them, marking a substantial improvement. Another study demonstrated that these methods improved screening in rural areas. This approach succeeds by engaging patients, providing reminders, and making screening more accessible. Overall, these methods have consistently proven effective in increasing screening rates, especially in resource-limited areas. ^{6 7 8 9 10}

Who Is on the Research Team?

Victoria Champion, PhD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for staff at certain clinics and patients aged 45-75 in rural Indiana who haven't had a colonoscopy in the past 10 years or a FIT test in the last year. It's not for those with inherited syndromes, inflammatory bowel disease, previous polyps, or colorectal cancer.

Inclusion Criteria

Only employees working at the clinics can participate.

I am between 45 and 75 years old.

I am either male or female.

Exclusion Criteria

I have a history of inflammatory bowel disease.

I have had a type of polyp called adenomatous before.

I have had colorectal cancer in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Planning and Usual Care

Usual care and planning period to establish baseline CRC screening rates and prepare for implementation

12 months

Implementation

Active implementation of the evidence-based intervention to improve CRC screening rates, including distribution of FIT kits and patient navigation

12 months

Maintenance

Monitoring continued adoption of the EBI and subsequent CRC screening, including annual repeat FIT screening and diagnostic colonoscopy

12 months

Follow-up

Participants are monitored for effectiveness and maintenance of CRC screening intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Colorectal Screen rates with implementation of evidence-based intervention

Trial Overview The study tests if mailing FIT kits, text reminders, phone calls, and using a Patient Navigator can increase colorectal cancer screening rates. It looks at how these methods work over time compared to usual care without these efforts.

How Is the Trial Designed?

Group I: Phase 3 Experimental Treatment 1 Intervention

Maintenance period.

Group II: Phase 2 Experimental Treatment 1 Intervention

Implementation period. Clinics are randomized into clusters

Group III: Phase 1 Active Control 1 Intervention

Usual care and planning period.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Indiana University Melvin and Bren Simon Cancer Center

Collaborator

Trials

7

Recruited

700+

Published Research Related to This Trial

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]

The implementation of organized colorectal cancer (CRC) screening significantly increased screening participation from 38.9% in 2000 to 82.7% in 2015, demonstrating effective outreach in a community-based population.

This increase in screening was associated with a 25.5% reduction in CRC incidence and a 52.4% reduction in cancer mortality, highlighting the program's effectiveness in early detection and prevention of advanced-stage cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Organized Colorectal Cancer Screening on Cancer Incidence and Mortality in a Large Community-Based Population. Levin, TR., Corley, DA., Jensen, CD., et al.[2022]

Mailed outreach strategies, especially those including fecal immunohistochemical tests (FIT) or guaiac-based fecal occult blood tests (gFOBT), significantly increased colorectal cancer screening adherence in low-income populations, with relative risks of 2.20 and 4.34 respectively.

Patient navigation and non-individualized education also effectively improved screening rates, while individualized education and mailed outreach with incentives did not show significant benefits, highlighting the importance of intervention design in promoting screening adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to increase colorectal cancer screening adherence in low-income settings within the United States: A systematic review and meta-analysis. Rubin, L., Okitondo, C., Haines, L., et al.[2023]

A controlled trial involving 443 participants tested a combined intervention of a patient decision aid and practice-level support to increase colorectal cancer (CRC) screening rates, showing a modest increase in screening from 32.2% in usual care to 39% in the intervention group.

The intervention was particularly more effective for participants with higher incomes, suggesting that socioeconomic factors may influence the success of CRC screening interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a patient and practice-level colorectal cancer screening intervention in health plan members: the CHOICE trial. Pignone, M., Winquist, A., Schild, LA., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11008572/

The Colorectal Cancer Screening Program, 2015–2017 The goal of this study is to better understand the effectiveness of the CRCCP components. Specifically, the purpose is to identify the key ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12239677/

Difference-making factors for successful implementation of a ... Rural disparities in colorectal cancer (CRC) screening persist despite the availability of effective, evidence-based interventions.

3. cdc.gov cdc.gov/pcd/issues/2022/21_0258.htm

Evaluating Uptake of Evidence-Based Interventions in 355 ... This program provided an opportunity to assess the uptake of EBIs and SAs in 355 clinics that participated from 2015 to 2018.

4. implementationsciencecomms.biomedcentral.com implementationsciencecomms.biomedcentral.com/articles/10.1186/s43058-025-00734-9

Sustainability of evidence based interventions implemented in ... These data include information on clinic characteristics, program implementation, and clinic-level screening prevalence. The data reporting ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2827026

Centralized Colorectal Cancer Screening Outreach in ... Colorectal cancer screening completion rates at 12 months were 34.6% vs 16.6% (difference, 17.99 percentage points; 95% CI, 15.30-20.69 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11188916/

The meta-analyses on effectiveness and safety ... There were 108 groups in 97 studies that reported severe bleeding caused by screening, 131 groups in 113 studies that reported perforation ...

7. gastrojournal.org gastrojournal.org/article/S0016-5085(24)05302-2/fulltext

Interventions to Increase Follow-Up of Abnormal Stool ... Interventions to increase follow-up of abnormal stool-based colorectal cancer screening tests in safety net settings: a systematic review.

8. cdc.gov cdc.gov/nccdphp/priorities/colorectal-cancer.html

Health and Economic Benefits of Colorectal Cancer ... Increasing screening prevalence to 80% could reduce the number of people diagnosed with colorectal cancer by 22% by 2030.6; REDUCE deaths.

9. sciencedirect.com sciencedirect.com/science/article/pii/S2211335519301743

Outcomes associated with use of the Cancer Risk Intake ... Outcomes associated with use of the Cancer Risk Intake System among primary care safety-net patients identified as needing colorectal cancer screening.

10. implementationscience.biomedcentral.com implementationscience.biomedcentral.com/articles/10.1186/1748-5908-8-58

Systems intervention to promote colon cancer screening in ... This paper describes the study protocol for a trial designed to increase colorectal cancer screening in those 'safety-net' health centers that ...