Colonoscopy Outreach for Rural Communities Aim 2

NCT05453630 | Completed

• 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

Outcome Measures

Primary Outcomes (1)

• Number of participants who complete colonoscopy within 1 year of the colonoscopy referral

  1 year

Secondary Outcomes (5)

• Number of participants who complete colonoscopy within 6 months of the colonoscopy referral

  6 months

• Time to completion of colonoscopy or end of follow-up after the colonoscopy referral

  1 year

• Number of participants who complete colonoscopy within 9 months of the colonoscopy referral

  9 months

• Number of participants who have completed colonoscopies with adequate preparation

  1 year

• Number of participants who have colonoscopies with cecal intubation

  1 year

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 (1)

• 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 DERIVED

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: Associate 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: August 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)