NCT03925883

Brief Summary

The prospective cohort study will evaluate the effectiveness of patient navigation in community health center settings. The investigators will collaborate with the advisory board, composed of key clinicians and patients, researchers, and policymakers, to establish a procedure to conduct and evaluate a patient navigation program that aims to increase rates of follow-up colonoscopy among diverse patient populations served by safety net clinics. Phase 1 will be a milestone-driven planning process in which the investigators will validate the risk prediction model and apply the risk prediction model to stratify the patients and adapt patient navigation materials for the local context. Phase II will be a large-scale, patient randomized-controlled trial that will include 1200 patients at a large 34-clinic community health center in Washington State.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 24, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

July 29, 2019

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2023

Completed
Last Updated

April 29, 2024

Status Verified

November 1, 2022

Enrollment Period

3.9 years

First QC Date

April 11, 2019

Last Update Submit

April 25, 2024

Conditions

Colorectal Cancer

Keywords

Colorectal cancer screeningCancer screeningRisk prediction modelPatient navigationColonoscopy

Outcome Measures

Primary Outcomes (1)

  • Rate of follow-up colonoscopy

    Receipt of colonoscopy within 1 year of abnormal Fecal Immunochemical Test (FIT) result

    12 months

Study Arms (2)

Patient Navigation

ACTIVE COMPARATOR

Patients randomized to this arm will receive patient navigation with the goal of completing a follow-up colonoscopy within 12 months of a positive FIT result.

Behavioral: Patient navigation

Usual Care

NO INTERVENTION

Patients will receive usual care screening opportunities

Interventions

Patient navigationBEHAVIORAL

Receive up to 6 live phone calls with a patient navigator for education, barrier assessment, and barrier resolution to follow up colonoscopy

Patient Navigation

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Positive FIT test

You may not qualify if:

  • Prior colorectal cancer
  • Dialysis patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

Related Publications (3)

  • Coronado GD, Petrik AF, Thompson JH, Leo MC, Slaughter M, Gautom P, Hussain SA, Mosso L, Gibbs J, Yadav N, Mummadi RR, Johnson ES, Jimenez R. Patient Navigation to Improve Colonoscopy Completion After an Abnormal Stool Test Result : A Randomized Controlled Trial. Ann Intern Med. 2025 May;178(5):645-654. doi: 10.7326/ANNALS-24-01885. Epub 2025 Apr 1.

    PMID: 40163863DERIVED

  • Coronado GD, Kihn-Stang A, Slaughter MT, Petrik AF, Thompson JH, Rivelli JS, Jimenez R, Gibbs J, Yadav N, Mummadi RR. Follow-up colonoscopy after an abnormal stool-based colorectal cancer screening result: analysis of steps in the colonoscopy completion process. BMC Gastroenterol. 2021 Sep 28;21(1):356. doi: 10.1186/s12876-021-01923-1.

    PMID: 34583638DERIVED

  • Coronado GD, Johnson ES, Leo MC, Schneider JL, Smith D, Mummadi R, Petrik AF, Thompson JH, Jimenez R. Patient randomized trial of a targeted navigation program to improve rates of follow-up colonoscopy in community health centers. Contemp Clin Trials. 2020 Feb;89:105920. doi: 10.1016/j.cct.2019.105920. Epub 2019 Dec 24.

    PMID: 31881390DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Patient-Centered CarePrimary Health CareComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Gloria Coronado, PhD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2019

First Posted

April 24, 2019

Study Start

July 29, 2019

Primary Completion

June 5, 2023

Study Completion

June 5, 2023

Last Updated

April 29, 2024

Record last verified: 2022-11

Locations

US(1)