Rural Colon Cancer Screening Toolkit Intervention

Colon Cancer Screening Clinical Trial

Official title:

Implementing Multilevel Colon Cancer Screening Interventions to Reduce Rural Cancer Disparities

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04651504
• Other study ID #: 202010206
• Secondary ID: 5R01CA233848-02
• Status: Recruiting
• Phase: N/A
• Start date: December 2, 2020
• Est. completion date: July 31, 2025

Study information

• Verified date: May 2024
• Source: Washington University School of Medicine
• Contact: Aimee James, Ph.D., MPH
• Phone: 314-454-8300
• Email: aimeejames[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 83663
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer Screening
• Colonic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of referrals for colonoscopies after positive fecal immunochemical test		Completion of follow-up (estimated to be 44 months)
Primary	Number of colonoscopy completions after positive fecal immunochemical test	-Within 60 days of referral	Completion of follow-up (estimated to be 44 months)
Secondary	Time to colonoscopy		Completion of follow-up (estimated to be 44 months)
Secondary	Proportion of participants who initiate a colonoscopy within 14 days of positive fecal immunochemical test		Completion of follow-up (estimated to be 44 months)
Secondary	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)

External Links

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