Rural Indiana Screening for Colorectal Cancer

NCT06133439 | Enrolling By Invitation

• 2 other identifiers: 15956R01CA276659
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

Colorectal Cancer

Outcome Measures

Primary Outcomes (3)

• Effectiveness and Maintenance

  The primary effectiveness measure will be the rate of uptake of a complete episode CRC screening, a rate that includes resolution of a positive FIT test with diagnostic colonoscopy.

  Up to 12 months

• Contextual factors

  Contextual factors will be measured at the beginning of Phase 2 and during the midpoint and end of Phase 3. Semi structured items are used for contextual factors and are guided by the iPARIHS framework. The final contextual factor construct assessed during the interview will be readiness to engage in implementation of the EBI, measured by the Organizational Readiness to Change Assessment (ORCA).

  Up to 12 months

• Implementation outcomes

  Measured by CC tracking forms, clinic logs that record all PN calls, adaptations to the implementation plan, fidelity measures and costs. The Clinic Implementation Tracking Form contains all essential tasks in the implementation plan including the dose and quality of intervention delivery. Overall quality of implementation and responsiveness to facilitation will be rated on a scale of 1 to 3. At the end of Phase 3, the investigators will interview two staff/clinic about their perceptions of the implementation. The investigators will also measure responses to a validated Acceptability scale using two staff/clinic at each clinic. All adaptations to the implementation plan will be recorded including rationale for change. Cost-data will be collected in phase 1 for usual care CRC screening promotion/education activities and throughout Phase 2 and 3 of implementation.

  Up to 36 months

Other Outcomes (1)

• Maintenance

  Up to 36 month

Study Arms (3)

Phase 1

NO INTERVENTION

Usual care and planning period.

Phase 2

OTHER

Implementation period. Clinics are randomized into clusters

Behavioral: Colorectal Screen rates with implementation of evidence-based intervention

Phase 3

OTHER

Maintenance period.

Behavioral: Colorectal Screen rates with implementation of evidence-based intervention

Interventions

Colorectal Screen rates with implementation of evidence-based intervention BEHAVIORAL

Mailed FIT kits, Cologuard, and diagnostic colonoscopies.

Phase 2; Phase 3

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants will be staff employed at the respective clinics. Patients will be age 45 to 75 and either male or female. Age limitations are necessary because colorectal cancer screening doesn't start until 45 and ends at 75.

You may not qualify if:

• Under surveillance (inherited familial syndromes),history of inflammatory bowel disease, and a previous adenomatous polyp, or previous colorectal cancer.

Sponsors & Collaborators

• Indiana University: lead
• Indiana University Melvin and Bren Simon Cancer Center: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Monroe Family Medicine (Adams Medical Group Monroe)

Monroe, Indiana, 46772, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Victoria Champion, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Cluster-Randomized Stepped Wedge design. Clinics will be randomized to one of three clusters that include four defined phases each consisting of nine-month segments.

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 15, 2023
• Study Start: January 3, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)