Colonoscopy Outreach for Rural Communities Aim 2

Study Overview
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Brief Summary
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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
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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.

Official Title
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Colonoscopy Outreach for Rural Communities Aim 2

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Behavioral: Patient Navigation
* Behavioral: Usual Care Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 915 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, patient navigation, colonoscopy, FIT, fecal immunochemical test, immunochemical fecal occult blood test, implementation effectiveness, colorectal cancer screening