Colonoscopy Outreach for Rural Communities Aim 2

NCT ID: NCT05453630

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 527 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-16
• Study Completion Date: 2025-07-15

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.

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Patient Navigation

Intervention Type: 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.

Standard of Care Control

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

Group Type: OTHER

Usual Care Control

Intervention Type: BEHAVIORAL

Educational brochure about colonoscopy

Interventions

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.

Intervention Type: BEHAVIORAL

Usual Care Control

Educational brochure about colonoscopy

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 915 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Alison Cole

Associate Professor, School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Allison M Cole, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38615750 (View on PubMed)

Other Identifiers

1R01CA254515-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00014807

Identifier Type: -

Identifier Source: org_study_id