Clinical trial NCT05453630: Colonoscopy Outreach for Rural Communities Aim 2
Official title: Colonoscopy Outreach for Rural Communities Aim 2
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Keywords: colorectal cancer
patient navigation
colonoscopy
FIT
fecal immunochemical test
immunochemical fecal occult blood test
implementation effectiveness
colorectal cancer screening
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-07-12
Enrollment: 527
Sex: ALL
Minimum age (years): 45
Maximum age (years): 915
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants who complete colonoscopy within 1 year of the colonoscopy referral
timeFrame: 1 year
Secondary outcomes:
measure: Number of participants who complete colonoscopy within 6 months of the colonoscopy referral
timeFrame: 6 months
measure: Time to completion of colonoscopy or end of follow-up after the colonoscopy referral
timeFrame: 1 year
measure: Number of participants who complete colonoscopy within 9 months of the colonoscopy referral
timeFrame: 9 months
measure: Number of participants who have completed colonoscopies with adequate preparation
timeFrame: 1 year
measure: Number of participants who have colonoscopies with cecal intubation
timeFrame: 1 year
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Allison M Cole, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: