Colon Cancer Screening Toolkit for Colorectal Cancer

Overseen By Aimee James, Ph.D., MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Age, Not clinic patient, others

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

Compensation: Varies

Number of Visits: Unknown

83663 Participants Needed

Trial Summary

What is the purpose of this trial?

Less than half of all positive fecal immunochemical testing (FIT)s are followed-up by colonoscopy, thus limiting the full potential of colorectal cancer (CRC) screening to reduce mortality. Given the need for coordination in order to achieve high rates of follow-up, multilevel approaches are needed. Such approaches could be particularly beneficial in communities and populations that experience cancer disparities and have fewer specialty providers, but most data focuses on large systems or urban areas. The academic-community health system collaboration is uniquely poised to address this research and service gap. The persistent poverty and health disparities in rural Southern Illinois set the stage for truly impactful research. The investigators' approach will serve as a model for multilevel interventions in rural settings, inform future work addressing other health disparities, and fill a gap in rigorous trials of CRC screening follow-up in rural areas.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Colorectal Cancer Toolkit for colorectal cancer?

Research shows that colorectal cancer screening, which is part of the Colorectal Cancer Toolkit, can reduce the incidence and mortality of colorectal cancer. High-quality screening processes are crucial in preventing cancer and cancer deaths. ^{1 2 3 4 5}

Is the Colon Cancer Screening Toolkit safe for humans?

Research on colon cancer screening methods like CT colonography and colonoscopy shows that while there are some risks of adverse events (unwanted side effects), these are generally rare. The studies highlight the importance of monitoring and minimizing these risks during screening procedures. ^{6 7 8 9 10}

How is the Colon Cancer Screening Toolkit treatment different from other colorectal cancer treatments?

The Colon Cancer Screening Toolkit is unique because it focuses on improving screening compliance and early detection of colorectal cancer, which can significantly reduce mortality. Unlike traditional treatments that address cancer after diagnosis, this toolkit aims to enhance screening strategies and adherence, potentially preventing cancer development or catching it at an earlier, more treatable stage. ^{11 12 13 14 15}

Research Team

Aimee James, Ph.D., MPH

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for people in rural Southern Illinois who have had a positive fecal immunochemical test (FIT) for colorectal cancer and need to follow up with a colonoscopy. It's focused on primary care clinic sites affiliated with the Southern Illinois Healthcare Physician Hospital Organization.

Inclusion Criteria

You are affiliated with Southern Illinois Healthcare's Physician Hospital Organization (PHO).

The sites must be able to provide a broad range of primary care services, including both medical and dental care

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of multilevel colon cancer screening interventions in rural settings

44 months

Virtual site visits and interviews with providers and staff

Follow-up

Participants are monitored for colonoscopy completions after positive fecal immunochemical test

60 days

Treatment Details

Interventions

• Colorectal Cancer Toolkit

Trial Overview The study is testing a 'Colorectal Cancer Toolkit' designed to improve follow-up rates after positive FIT results. The goal is to see if this toolkit helps more people get colonoscopies, which could lead to earlier detection of colorectal cancer in rural areas.

Participant Groups

Group I: Primary Care Clinics Experimental Treatment 1 Intervention

* Southern Illinois Healthcare System will contact the site management and ask for participation in the study * Eligible providers and staff will be identified by clinic management. The research coordinator will work with the clinic to schedule a virtual site visit(s). The study team will interview providers and staff at the beginning and/or end of each active intervention period to assess knowledge and attitudes about CRC screening and follow-up processes, the Consolidated Framework for Implementation Research (CFIR) constructs such as role clarity within the clinical team, and satisfaction with the intervention and implementation. Post-implementation surveys will also ask about work-arounds and adaptations of the intervention tools and perceived efficacy.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Colonoscopy screening, when performed effectively, significantly reduces the risk of colorectal cancer and related mortality, but variations in the screening process can lead to failures that increase health risks.

Quality improvement in colonoscopy screening is essential, as higher quality practices have been shown to prevent cancer incidence and deaths, necessitating comprehensive guidelines for operators and systems to enhance screening outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing the Quality of Colorectal Cancer Screening Worldwide. Kaminski, MF., Robertson, DJ., Senore, C., et al.[2020]

A randomized controlled trial will assess the effectiveness of a print-based intervention aimed at improving adherence to colonoscopy surveillance for colorectal cancer (CRC) patients and screening for their first-degree relatives, involving participants diagnosed with CRC within the last 10 months.

The study aims to provide evidence on effective strategies to enhance guideline adherence for CRC surveillance and screening, potentially improving outcomes for patients and their families over a follow-up period of 36 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving adherence to surveillance and screening recommendations for people with colorectal cancer and their first degree relatives: a randomized controlled trial. Carey, M., Sanson-Fisher, R., Macrae, F., et al.[2021]

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]

Only 42.5% of U.S. adults aged 50 and older reported undergoing recommended colorectal cancer tests, highlighting a significant gap in screening despite its effectiveness in reducing cancer incidence and mortality.

Key barriers to screening included lack of awareness and not receiving a recommendation from a physician, indicating that improving education and access to healthcare could enhance screening rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns and predictors of colorectal cancer test use in the adult U.S. population. Seeff, LC., Nadel, MR., Klabunde, CN., et al.[2022]

The proportion of individuals aged 50 to 75 years who were up to date with colorectal cancer screening increased significantly from 50.4% in 2011 to 69.7% in 2019, indicating improved screening rates over time.

The introduction of the multitarget stool DNA (mt-sDNA) test led to a notable increase in its use from 1.9% in 2016 to 14.2% in 2019, while the use of high-sensitivity fecal occult blood tests (FOBT) decreased from 17.7% to 6.6% during the same period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of a Colorectal Cancer Screening Test Among Individuals With Average Risk. Fisher, DA., Princic, N., Miller-Wilson, LA., et al.[2022]

A large-scale survey of 147,439 computed tomographic colonography (CTC) examinations found a very low risk of adverse events, with colorectal perforations occurring in only 0.014% of cases and no reported deaths.

The risk of colorectal perforation was significantly lower during screening procedures (0.003%) compared to preoperative staging (0.028%), and 81% of perforation cases did not require emergency surgery, indicating that CTC is a safe option for colorectal cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events during CT colonography for screening, diagnosis and preoperative staging of colorectal cancer: a Japanese national survey. Nagata, K., Takabayashi, K., Yasuda, T., et al.[2022]

In a study of 3121 asymptomatic veterans who underwent colonoscopy screening, adverse events occurred in only 2.8% of follow-up examinations, indicating that long-term colonoscopy screening is generally safe.

Serious cardiopulmonary events were the most common major complications, and a history of prior colonoscopic adverse events significantly increased the risk of future complications, suggesting the importance of assessing patients' medical histories before follow-up procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal assessment of colonoscopy adverse events in the prospective Cooperative Studies Program no. 380 colorectal cancer screening and surveillance cohort. Kobe, EA., Sullivan, BA., Qin, X., et al.[2023]

In a study analyzing 130,831 colonoscopies, the overall bleeding rate was found to be 0.65%, with a very low rate of bleeding requiring transfusion (0.04%) and perforation (0.06%), indicating that the NHS bowel cancer screening program is relatively safe.

The study identified that larger polyp size and cecal location significantly increase the risk of adverse events, with cecal polypectomy showing a 13.5-fold increased risk of bleeding requiring transfusion and a 12.2-fold increased risk of perforation compared to distal colon procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for adverse events related to polypectomy in the English Bowel Cancer Screening Programme. Rutter, MD., Nickerson, C., Rees, CJ., et al.[2022]

In a study of 17,067 CT colonography examinations across 50 centers, only 0.08% of patients experienced potentially serious adverse events, indicating a very low incidence of complications associated with the procedure.

Among the adverse events, there were nine perforations, with a symptomatic perforation rate of just 0.03%, suggesting that while complications can occur, they are rare and often asymptomatic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potentially serious adverse events at CT colonography in symptomatic patients: national survey of the United Kingdom. Burling, D., Halligan, S., Slater, A., et al.[2016]

In a study of 1092 patients who underwent colorectal surgery as part of a screening program, 19.2% experienced in-hospital complications, with 5.9% classified as severe, highlighting the risks associated with surgical interventions in colorectal cancer screening.

Factors such as male sex, age over 60, and rectal lesion location were significantly associated with higher rates of complications, indicating that these demographics should be carefully considered when evaluating candidates for surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical complications in a population-based colorectal cancer screening program: Incidence and associated factors. Sánchez Gómez, CA., Tejido Sandoval, C., de Vicente Bielza, N., et al.[2022]

About 30% of fecal immunochemical tests (FITs) for colorectal cancer screening were ordered prematurely, meaning they were done before the recommended time after a previous negative test, which could lead to unnecessary stress and resource waste.

Men were more likely to return for early screening than women, and male physicians were more likely to order these premature tests, indicating a potential need for better adherence to screening guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Premature Fecal Immunochemical Testing in British Columbia Canada: a Retrospective Review of Physician and Screening Participant Characteristics. Sanders, D., Bakos, B., Gentile, L., et al.[2023]

Colorectal cancer screening significantly reduces mortality in individuals aged 50 and older, yet screening rates remain low despite the availability of various recommended tests like colonoscopy and fecal occult blood tests.

Barriers to screening exist for both patients and physicians, highlighting the need for strategies to improve compliance and increase participation in colorectal cancer screening programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colorectal cancer screening: clinical applications. Walsh, JM., Terdiman, JP.[2019]

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]

Colorectal cancer (CRC) screening has significantly contributed to the decline in CRC-related mortality by enabling early detection, highlighting the importance of following established guidelines.

The NCCN Guidelines for CRC Screening provide healthcare providers with recommendations tailored to individual risk levels, and the review also discusses the potential of emerging biomarkers to enhance screening effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of NCCN Guidelines, Other Guidelines, and Biomarkers for Colorectal Cancer Screening. Williams, CD., Grady, WM., Zullig, LL.[2021]

Screening for colorectal cancer (CRC) and its precursors, like adenomas, is crucial for reducing mortality rates, with improved screening programs contributing to a decline in CRC deaths in industrialized countries.

Various screening methods exist, including fecal tests and structural tests like colonoscopy, but the newer video-colon capsule requires more research before it can be widely adopted as a screening tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidelines for colorectal cancer screening--a puzzle of tests and strategies. Van Gossum, A.[2016]

References

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

Optimizing the Quality of Colorectal Cancer Screening Worldwide. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Improving adherence to surveillance and screening recommendations for people with colorectal cancer and their first degree relatives: a randomized controlled trial. [2021]

3. United States 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. [2022]

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

Patterns and predictors of colorectal cancer test use in the adult U.S. population. [2022]

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

Utilization of a Colorectal Cancer Screening Test Among Individuals With Average Risk. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Adverse events during CT colonography for screening, diagnosis and preoperative staging of colorectal cancer: a Japanese national survey. [2022]

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

Longitudinal assessment of colonoscopy adverse events in the prospective Cooperative Studies Program no. 380 colorectal cancer screening and surveillance cohort. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Risk factors for adverse events related to polypectomy in the English Bowel Cancer Screening Programme. [2022]

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

Potentially serious adverse events at CT colonography in symptomatic patients: national survey of the United Kingdom. [2016]

10. Spain pubmed.ncbi.nlm.nih.gov

Surgical complications in a population-based colorectal cancer screening program: Incidence and associated factors. [2022]

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

Premature Fecal Immunochemical Testing in British Columbia Canada: a Retrospective Review of Physician and Screening Participant Characteristics. [2023]

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

Colorectal cancer screening: clinical applications. [2019]

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

Effectiveness of a patient and practice-level colorectal cancer screening intervention in health plan members: the CHOICE trial. [2021]

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

Use of NCCN Guidelines, Other Guidelines, and Biomarkers for Colorectal Cancer Screening. [2021]

15. England pubmed.ncbi.nlm.nih.gov

Guidelines for colorectal cancer screening--a puzzle of tests and strategies. [2016]