Colonoscopy Outreach for Rural Communities Aim 2

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Usual Care Control; Behavioral: Patient Navigation

Detailed Description

Colorectal cancer (CRC) is a leading cause of cancer death in the United States and its burden is greater in rural and low-income communities. Failure to complete recommended colonoscopy contributes to later-stage CRC diagnosis and worse CRC outcomes, which means timely and successful colonoscopy is a key opportunity to reduce CRC mortality. Using a Type 1 Hybrid Implementation-Effectiveness design, we will randomize 480-600 subjects from 6-8 primary care clinical organizations in a randomized controlled trial (RCT) to accomplish the following:

• Test the effectiveness of a patient navigation program, remotely-delivered by a community-based organization, for increasing colonoscopy completion rates for colorectal cancer screening among rural patients.
• Assess implementation and sustainability of the patient navigation program from the perspectives of both community and clinical stakeholders.

• Study Type: Interventional
• Enrollment (Actual): 527
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient Navigation Intervention; 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; 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.
Other: Standard of Care Control; Participants randomized to this arm will receive an educational brochure about the importance of colonoscopy to screen for colorectal cancer.	Behavioral: Usual Care Control; Educational brochure about colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants who complete colonoscopy within 1 year of the colonoscopy referral	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Allison M Cole, MD, MPH, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2022
• Primary Completion (Actual): July 15, 2025
• Study Completion (Actual): July 15, 2025

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: colorectal cancer; colonoscopy; FIT; colorectal cancer screening; patient navigation; fecal immunochemical test; immunochemical fecal occult blood test; implementation effectiveness
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: STUDY00014807; 1R01CA254515-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No