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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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