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Completed

NCT Number: NCT04651504

Rural Colon Cancer Screening Toolkit Intervention

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.

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Key information

Conditions

Colon Cancer Screening

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Primary Care Clinic Sites

  • Physician Hospital Organization (PHO) affiliated with Southern Illinois Healthcare

Exclusion criteria

for Primary Care Clinic Sites

  • Not a part of the PHO

Inclusion criteria

for Physicians and Staff at Primary Care Clinic Sites

  • Employment at the relevant clinic at the time of the study

Exclusion criteria

for Physicians and Staff at Primary Care Clinic Sites

  • Not employed at the relevant clinic at the time of the study

Inclusion criteria

for Patients

  • Age 45-75 during the study period
  • Must be patient of the selected primary care clinic sites

Exclusion criteria

for Patients

  • Younger than 45 years of age or older than 75 years of age during the study period
  • Not a patient of the selected primary care clinic sites

Inclusion criteria

for Community Members

  • Age 45-75 at the time of the health fair or screening event
  • Able to undergo stool testing as determined by SIH staff at the health fair or screening event

Exclusion criteria

for Community Members

  • Younger than 45 years of age or older than 75 years of age
  • Unable to undergo stool testing

Treatment and study plan

Colorectal Cancer Toolkit

Other

The intervention toolkit will include patient education materials and supportive materials for providers. Tracking systems and supports will be jointly developed with participating clinic and providers, in order to maximize their existing systems and develop processes that meet their needs and preferences, and training will be offered to help providers/teams efficiently use the tracking system and clinic resources. The study team will provide technical assistance and support through email, phone and zoom to support the clinic in their implementation process.

Primary outcomes

  1. Number of Referrals for Colonoscopies After Positive Fecal Immunochemical Test

    Time frame: Within 60 days after receipt of positive FIT/FOBT

    • Patients between 07/01/2021 - 12/31/2024 that had a fecal immunochemical test (FIT)/fecal occult blood test (FOBT) test performed with a positive result and had an ambulatory referral to Gastroenterology within 60 days of getting the results from the lab test.
    • Separate data for the Arms cannot be provided, as referrals were not able to be obtained from registry data due to unanticipated registry provider changes prior to study start & major delays & staff shortages due to COVID shutdowns, which prevented the collection of colonoscopy referrals. The referral data was obtained from the hospital sites that used EPIC but could not be differentiated by arms. Data for the remaining outcome measures was able to be differentiated by arm as the data came from the registry versus EPIC.

  2. Number of Colonoscopy Completions After Positive Fecal Immunochemical Test (FIT)

    Time frame: Within 60 days of referral to Gastroenterology

Secondary outcomes

  1. Time to Colonoscopy

    Time frame: Through completion of follow-up (range of 91-1278 days): mean=844 days, standard deviation=440 days

    Time between FIT date and colonoscopy.

  2. Proportion of Participants Who Initiate a Colonoscopy Within 14 Days of Positive Fecal Immunochemical Test

    Time frame: Within 14 days of positive fecal immunochemical test

  3. Proportion of Patients Who Complete a Complete Diagnostic Evaluation Within 60 Days of Positive Fecal Immunochemical Test

    Time frame: Within 60 days after receipt of positive FIT/FOBT

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

Implementing Multilevel Colon Cancer Screening Interventions to Reduce Rural Cancer Disparities

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Dec 3, 2020
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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