Colonoscopy Outreach for Rural Communities Aim 2

Not Applicable

Active, not recruiting

• Conditions: Colorectal Cancer
• Interventions: Behavioral: Usual Care Control; Behavioral: Patient Navigation

• Registration Number: NCT05453630
• Lead Sponsor: University of Washington

Brief Summary

This study aims to test the effectiveness of a 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 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 Timeline

• Study Start: 2022-06-16
• Study First Submitted: 2022-07-06
• Study First Submitted QC: 2022-07-06
• Study First Posted: 2022-07-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-30
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 527

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care Control	Usual Care Control	Participants randomized to this arm will receive an educational brochure about the importance of colonoscopy to screen for colorectal cancer.
Patient Navigation Intervention	Patient Navigation	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.

Primary Outcome Measures

Name	Time	Method
Number of participants who complete colonoscopy within 1 year of the colonoscopy referral	1 year

Secondary Outcome Measures

Name	Time	Method
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 have colonoscopies with cecal intubation	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

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States