Colonoscopy Outreach for Rural Communities Aim 2

Colorectal Cancer Clinical Trial

Official title:

Colonoscopy Outreach for Rural Communities Aim 2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05453630
• Other study ID #: STUDY00014807
• Secondary ID: 1R01CA254515-01
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2022
• Est. completion date: July 31, 2025

Study information

• Verified date: November 2023
• Source: University of Washington
• Contact: Gina Keppel, MPH
• Phone: 360-292-4139
• Email: gakeppel[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 an 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 915 Months

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.
• Usual Care Control
Educational brochure about colonoscopy

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who complete colonoscopy within 1 year of the colonoscopy referral		1 year
Secondary	Number of participants who complete colonoscopy within 6 months of the colonoscopy referral		6 months
Secondary	Time to completion of colonoscopy or end of follow-up after the colonoscopy referral		1 year
Secondary	Number of participants who complete colonoscopy within 9 months of the colonoscopy referral		9 months
Secondary	Number of participants who have completed colonoscopies with adequate preparation		1 year
Secondary	Number of participants who have colonoscopies with cecal intubation		1 year