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Rural Indiana Screening for Colorectal Cancer

NCT06133439 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2026-04-14

No results posted yet for this study

Summary

The goal of this implementation study is to support an evidence-based intervention to the improve colorectal cancer (CRC) screening and diagnostic colonoscopy rates in rural Indiana. The main questions the study aims to answer are:

* How does the implementation of an evidence based intervention to increase CRC screening in rural Indiana improve CRC screening and diagnostic colonoscopy rates, defined as completed screening episode?
* Will dose and type of implementation strategies contribute to differences in contextual factors and readiness as well as different levels of implementation outcomes (reach and implementation) in rural clinic?
* Will Contextual factors (innovation, recipient, inner and outer context) and implementation outcomes (reach, and implementation) vary with the levels of CRC screening and diagnostic colonoscopy following active implementation (effectiveness) and throughout maintenance compared to baseline (usual care)?
* What is the cost and budget impact of the deployment of implementation strategies and processes for rural clinics and evaluate the cost-effectiveness of implementing and sustaining the CRC screening intervention?

Approach: Participating clinics tasks consist of mailing FIT kits, sending text messages, phone reminders, and the use of a Patient Navigator to initiate a screening episode with eligible patients who are 45-75 (and have no colonoscopy in the last 10 years or FIT in the last 12 months) as identified from medical records.

Conditions

Interventions

BEHAVIORAL

Colorectal Screen rates with implementation of evidence-based intervention

Mailed FIT kits, Cologuard, and diagnostic colonoscopies.

Sponsors & Collaborators

  • Indiana University Melvin and Bren Simon Cancer Center

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Indiana University

    lead OTHER

Principal Investigators

  • Victoria Champion, PhD · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-03
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06133439 on ClinicalTrials.gov