Colonoscopy Outreach for Rural Communities Aim 2

Sponsor

University of Washington (Other)

Overall Status

Recruiting

CT.gov ID

NCT05453630

Collaborator

National Cancer Institute (NCI) (NIH)

480

Enrollment

Location

Arms

37.5

Anticipated Duration (Months)

12.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Behavioral: Patient Navigation Behavioral: Usual Care Control	N/A

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 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 and rural-serving patients.
Assess implementation and sustainability of the patient navigation program from the perspectives of both community and clinical stakeholders.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

480 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

Colonoscopy Outreach for Rural Communities Aim 2

Actual Study Start Date :

Jun 16, 2022

Anticipated Primary Completion Date :

Jul 31, 2025

Anticipated Study Completion Date :

Jul 31, 2025

Arms and Interventions

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 the community-based Washington Association for Community Health. 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: Usual 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

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 the community-based Washington Association for Community Health. 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: Usual 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

Outcome Measures

Primary Outcome Measures

Number of participants who complete colonoscopy within 1 year of the colonoscopy referral [1 year]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 915 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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
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