Accelerating Colorectal Cancer Screening Through Implementation Science in Appalachia

Colorectal Cancer Clinical Trial

— ACCSIS  

Official title:

Accelerating Colorectal Cancer Screening Through Implementation Science in Appalachia (ACCSIS)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04427527
• Other study ID #: 2018C0166
• Secondary ID: UH3CA23328283212
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 19, 2020
• Est. completion date: August 31, 2024

Study information

• Verified date: May 2024
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project aims to implement a multi-level group randomized trial, delayed intervention that includes components targeting clinics, providers, patients, and the community to increase colorectal cancer (CRC) screening, follow-up, and referral-to-care among patients age 50-74 in 12 counties in Appalachian Kentucky and Ohio. The 12 counties will be assigned to one of two study groups (early vs. delayed) and outcome measures (rate of CRC screening) will be obtained from clinic-level electronic health record data and a county-level behavioral assessment telephone survey. The hypothesis for the project is that the multi-level intervention will increase the clinic and county level CRC screening rates.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5425
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 74 Years

Eligibility

Inclusion Criteria:

• age 50-74

• all races, sexes and genders

• resident of the study area

Exclusion Criteria:

.no exclusions based on gender, race or ethnicity

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Multi-level intervention to increase CRC screening
Intervention for the community, providers, patients, clinics and systems

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio
United States	Markey Cancer Center	Lexington	Kentucky

Sponsors (3)

Lead Sponsor	Collaborator
University of Kentucky	National Cancer Institute (NCI), Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CRC screening - clinic level	Change in clinic-level screening rate from baseline to the end of the 12-month active intervention period, assessed through clinic electronic health record data	12 months
Secondary	CRC screening - community level	Self-reported participation in CRC screening from baseline to the end of the 12-month active intervention period, assessed through telephone surveys	12 months