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Colonoscopy Outreach for Rural Communities Aim 2

Primary Purpose

Colorectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Navigation
Usual Care Control
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colorectal Cancer focused on measuring colorectal cancer, patient navigation, colonoscopy, FIT, fecal immunochemical test, immunochemical fecal occult blood test, implementation effectiveness, colorectal cancer screening

Eligibility Criteria

45 Years - 915 Months (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of WashingtonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Patient Navigation Intervention

Usual Care Control

Arm Description

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.

Participants randomized to this arm will receive an educational brochure about the importance of colonoscopy to screen for colorectal cancer.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of participants who complete colonoscopy within 6 months of the colonoscopy referral
Time to completion of colonoscopy or end of follow-up after the colonoscopy referral
Number of participants who complete colonoscopy within 9 months of the colonoscopy referral
Number of participants who have completed colonoscopies with adequate preparation
Number of participants who have colonoscopies with cecal intubation

Full Information

First Posted
July 6, 2022
Last Updated
October 23, 2023
Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05453630
Brief Title
Colonoscopy Outreach for Rural Communities Aim 2
Official Title
Colonoscopy Outreach for Rural Communities Aim 2
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2022 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer, patient navigation, colonoscopy, FIT, fecal immunochemical test, immunochemical fecal occult blood test, implementation effectiveness, colorectal cancer screening

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient Navigation Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care Control
Arm Type
Other
Arm Description
Participants randomized to this arm will receive an educational brochure about the importance of colonoscopy to screen for colorectal cancer.
Intervention Type
Behavioral
Intervention Name(s)
Patient Navigation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care Control
Intervention Description
Educational brochure about colonoscopy
Primary Outcome Measure Information:
Title
Number of participants who complete colonoscopy within 1 year of the colonoscopy referral
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of participants who complete colonoscopy within 6 months of the colonoscopy referral
Time Frame
6 months
Title
Time to completion of colonoscopy or end of follow-up after the colonoscopy referral
Time Frame
1 year
Title
Number of participants who complete colonoscopy within 9 months of the colonoscopy referral
Time Frame
9 months
Title
Number of participants who have completed colonoscopies with adequate preparation
Time Frame
1 year
Title
Number of participants who have colonoscopies with cecal intubation
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
915 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gina Keppel, MPH
Phone
360-292-4139
Email
gakeppel@uw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Brooke Ike, MPH
Email
bike2@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison M Cole, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gina Keppel, MPH
Phone
360-292-4139

12. IPD Sharing Statement

Plan to Share IPD
No

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Colonoscopy Outreach for Rural Communities Aim 2

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