Colonoscopy Outreach for Rural Communities Aim 2

NCT05453630 | Completed Results

• 2 other identifiers: STUDY000148071R01CA254515-01
• Study Type: interventional
• Target: 527
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to test the effectiveness of a remotely-delivered patient navigation program for increasing colonoscopy completion for colorectal cancer screening, among rural populations. The study will partner with geographically disparate primary care organizations to recruit patients aged 45-75 to the study. The patient navigation program will be delivered through a community organization. This project is critical in advancing our knowledge of the effectiveness of patient navigation for increasing colonoscopy in this patient population as well as for understanding factors that can support long term implementation and sustainability of effective interventions.

Conditions

Colorectal Cancer

Keywords

colorectal cancer; patient navigation; colonoscopy; FIT; fecal immunochemical test; immunochemical fecal occult blood test; implementation effectiveness; colorectal cancer screening

Study Arms (2)

Patient Navigation Intervention

EXPERIMENTAL

Patients randomized to this arm will receive language-concordant patient navigation from a trained navigator, over the phone and via text and email, to assist patients to complete colonoscopy to screen for colorectal cancer.

Behavioral: Patient Navigation

Standard of Care Control

OTHER

Participants randomized to this arm will receive an educational brochure about the importance of colonoscopy to screen for colorectal cancer.

Behavioral: Usual Care Control

Interventions

Patient Navigation BEHAVIORAL

Patients will receive navigation from a trained lay navigator at a community-based nonprofit organization that supports access to high quality healthcare. The patient navigator will work with patients to schedule their colonoscopy and identify, explore, and overcome barriers. They will educate patients about the colonoscopy procedure and preparation, provide resources, and coach and motivate patients.

Patient Navigation Intervention

Usual Care Control BEHAVIORAL

Educational brochure about colonoscopy

Standard of Care Control

Eligibility Criteria

• Age: 45 Years - 915 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 45-76.25 on the date of their referral for colonoscopy
• Referred for colonoscopy as part of colorectal cancer screening in the last 3 months. This includes patients referred for colonoscopy after an abnormal stool screening test (e.g., FIT/FOBT/Cologuard) and patients referred for colonoscopy as a primary screening test for colorectal cancer.

You may not qualify if:

• Deceased
• Colonoscopy procedure since colonoscopy referral
• Colonoscopy procedure scheduled less than or equal to 7 days from study enrollment date
• Colonoscopy procedure scheduled more than 9 months from colonoscopy referral date (if known at enrollment)
• Have diagnosis or past history of total colectomy or colorectal cancer (malignant neoplasm) at any time
• Has hospice
• Aged 66 and older living long-term in an institution for more than 90 consecutive days during the year prior to the query

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (3)

• Ike B, Keppel GA, Cole A. Rural barriers to colonoscopy screening identified through patient navigation. PEC Innov. 2026 Apr 3;8:100475. doi: 10.1016/j.pecinn.2026.100475. eCollection 2026 Jun.

  PMID: 42005421 BACKGROUND

• Keppel GA, Ike B, Leroux BG, Ko LK, Osterhage KP, Jacobs JD, Cole AM. Colonoscopy Outreach for Rural Communities (CORC): A study protocol of a pragmatic randomized controlled trial of a patient navigation program to improve colonoscopy completion for colorectal cancer screening. Contemp Clin Trials. 2024 Jun;141:107539. doi: 10.1016/j.cct.2024.107539. Epub 2024 Apr 12.

  PMID: 38615750 BACKGROUND

• Ike B, Keppel GA, Osterhage KP, Ko LK, Cole A. Adapting a Remotely Delivered Patient Navigation Program for Colorectal Cancer Screening in Primary Care: Important Considerations for Rural Contexts. J Prim Care Community Health. 2024 Jan-Dec;15:21501319241288025. doi: 10.1177/21501319241288025.

  PMID: 39439281 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Patient Navigation

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

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Allison M Cole, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 12, 2022
• Study Start: June 16, 2022
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: July 15, 2026
• Results First Posted: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Access Criteria: Investigators should submit a reasonable and methodologically sound request, in writing, to the study's Principal Investigator, Dr. Allison Cole. A data sharing agreement may be required.

Locations

US (1)