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Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

Predicting and Addressing Colonoscopy in Safety Net Settings

Clinicaltrials.gov identifier NCT03925883

Recruitment Status Enrolling by invitation

First Posted April 24, 2019

Last update posted September 16, 2020

Study Description

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.

  • Condition or Disease:Colorectal Cancer
  • Intervention/Treatment: Behavioral: Patient navigation
  • Phase: N/A
Detailed Description

The study will fulfill the following aims: Aim 1: Validate externally the predictive risk score using Sea Mar CHC's robust data including 29,000 patients age-eligible for colorectal cancer screening; stratify patients according to risk of non-adherence to follow-up colonoscopy; and adapt patient navigation program for the local context. Aim 2: Assess the effectiveness, costs, and cost-effectiveness of a centralized, phone-based patient navigation program for follow-up colonoscopy receipt for patients at moderate risk or high risk for non-adherence. Aim 3: Assess differences in the intervention arms in secondary outcomes (e.g. time to colonoscopy receipt, no-show/canceled appointments, colonoscopy quality) and moderators of intervention effectiveness (e.g. probability level, intervention dose, and patient age, ethnicity, and sex)

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 252 participants
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Screening
  • Official Title: Predicting and Addressing Colonoscopy in Safety Net Settings
  • Actual Study Start Date: July 2019
  • Estimated Primary Completion Date: March 2022
  • Estimated Study Completion Date: March 2022
Arms and interventions
Arm Intervention/treatment
Active Comparator: Patient Navigation
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
Receive up to 6 live phone calls with a patient navigator for education, barrier assessment, and barrier resolution to follow up colonoscopy
Outcome Measures
  • Primary Outcome Measures: 1. Rate of follow-up colonoscopy [ Time Frame: 12 months ]
    Receipt of colonoscopy within 1 year of abnormal Fecal Immunochemical Test (FIT) result
Eligibility Criteria
  • Ages Eligible for Study: 50 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Inclusion Criteria:

- Positive FIT test

Exclusion Criteria:

- Prior colorectal cancer

- Dialysis patient

Contacts and Locations

United States, Oregon
Kaiser Permanente Center for Health Research

Sponsors and Collaborators

Kaiser Permanente

National Cancer Institute (NCI)

Sea Mar Community Health Centers


Principal Investigator: Gloria Coronado, PhD Kaiser Permanente

More Information
  • Responsible Party: Kaiser Permanente
  • ClinicalTrials.gov Identifier: NCT03925883 History of Changes
  • Other Study ID Numbers: 1R01CA218923-01A1, R01CA218923
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: September 16, 2020
  • Last Verified: September 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Kaiser Permanente: Colorectal cancer screening
    Cancer screening
    Risk prediction model
    Patient navigation
  • Additional relevant MeSH terms: Colorectal Neoplasms