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Completed

NCT Number: NCT05453630

Colonoscopy Outreach for Rural Communities Aim 2

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

45 year–915 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Navigation

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.

Usual Care Control

Behavioral

Educational brochure about colonoscopy

Primary outcomes

  1. Number of Participants Who Complete Colonoscopy Within 1 Year of the Colonoscopy Referral

    Time frame: 1 year

    Number of participants who received a colonoscopy within 12 months (365 days) of their referral for the procedure. Electronic health record documentation of the procedure (e.g., procedure report, pathology report, results letter) or self-report was used to determine whether the patient received the colonoscopy.

Secondary outcomes

  1. Number of Participants Who Complete Colonoscopy Within 9 Months of the Colonoscopy Referral

    Time frame: 9 months

    Number of participants who received a colonoscopy within 9 months (274 days) of their referral for the procedure. Electronic health record documentation of the procedure (e.g., procedure report, pathology report, results letter) or self-report was used to determine whether the patient received the colonoscopy.

  2. Number of Participants Who Complete Colonoscopy Within 6 Months of the Colonoscopy Referral

    Time frame: 6 months

    Number of participants who received a colonoscopy within 6 months (183 days) of their referral for the procedure. Electronic health record documentation of the procedure (e.g., procedure report, pathology report, results letter) or self-report was used to determine whether the patient received the colonoscopy.

  3. Time to Completion of Colonoscopy or End of Follow-up After the Colonoscopy Referral

    Time frame: 1 year

    Kaplan-Meier estimated median days to completion. Based on the number of days to colonoscopy completion or end of the 12 month (365 day) follow-up period, from the participant's referral for the procedure. Electronic health record documentation of the procedure (e.g., procedure report, pathology report, results letter) or self-report was used to determine whether the patient received the colonoscopy.

  4. Number of Participants Who Have Completed Colonoscopies With Adequate Preparation

    Time frame: 1 year

    Number of participants who received a colonoscopy within 12 months of their referral who had documentation of adequate bowel preparation in their electronic health record. Adequate bowel preparation was defined as a subjective rating of fair, adequate, good, or excellent; or a Boston Bowel Preparation Score (BBPS) total of 6 or higher. The BBPS scale ranges from 0-9 with higher values indicating better preparation.

  5. Number of Participants Who Have Colonoscopies With Cecal Intubation

    Time frame: 1 year

    Number of participants who received a colonoscopy within 12 months of their referral who had documentation of cecal intubation in their electronic health record. Cecal intubation was considered achieved if there was text documenting reaching the cecum or photographic documentation labeled with cecal landmarks in the procedure information.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 12, 2022
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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