Rural Colon Cancer Screening Toolkit Intervention

Implementing Multilevel Colon Cancer Screening Interventions to Reduce Rural Cancer Disparities

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.

Study Overview

• Status: Completed
• Conditions: Colon Cancer Screening
• Intervention / Treatment: Other: Colorectal Cancer Toolkit

• Study Type: Interventional
• Enrollment (Actual): 185903
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Primary Care Clinics; 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.

Other: Colorectal Cancer Toolkit; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of referrals for colonoscopies after positive fecal immunochemical test		Completion of follow-up (estimated to be 44 months)
Number of colonoscopy completions after positive fecal immunochemical test	-Within 60 days of referral	Completion of follow-up (estimated to be 44 months)

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to colonoscopy	Completion of follow-up (estimated to be 44 months)
Proportion of participants who initiate a colonoscopy within 14 days of positive fecal immunochemical test	Completion of follow-up (estimated to be 44 months)
Proportion of patients who complete a complete diagnostic evaluation within 60 days of positive fecal immunochemical test	Completion of follow-up (estimated to be 44 months)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Aimee James, Ph.D., MPH, Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2020
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: November 25, 2020
• First Submitted That Met QC Criteria: November 25, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Estimated): October 22, 2025
• Last Update Submitted That Met QC Criteria: October 20, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Colonic Neoplasms
• Other Study ID Numbers: 202010206; 5R01CA233848-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No