Improving Colorectal Cancer Screening in Racially Diverse Zip Codes Using Navigation and Machine Learning (PCSNaP) (PCSNaP)

February 10, 2026 updated by: Carmen E. Guerra, MD, MSCE, FACP, Abramson Cancer Center at Penn Medicine

A Feasibility Study to Improve Colorectal Cancer Screening Among Racially Diverse Zip Codes in a Persistent Poverty County Using Navigation and Machine Learning Predictive Algorithms

The overarching goal of the "PCSNaP" Research Study is to support the Abramson Cancer Center (ACC) of the University of Pennsylvania in carrying out its mission to increase colorectal cancer (CRC) screening completion among high-risk individuals living in a persistent poverty county by designing, conducting, disseminating and evaluating an electronic health record-based automated identification program to target effective, culturally-sensitive CRC screening navigation to individuals who have not completed an ordered colonoscopy or fecal immunochemical test (FIT).

Study Overview

Detailed Description

Specifically, the goals of this study are to: 1) Adapt a previously validated electronic health record (EHR)-based machine learning algorithm to predict colorectal cancer (CRC) detection by retraining the model using data from patients seen in primary care clinics serving zip codes with a high proportion of racial and ethnic minorities living in Philadelphia County, a persistent poverty county; and 2) Implement and evaluate the feasibility and effectiveness of an algorithm-based CRC navigation program to increase colorectal cancer screening among patients in Philadelphia county who are at high risk of CRC and have uncompleted colonoscopies.

Together, these novel projects aim to be the first to combine use of machine learning algorithms and patient navigation to increase guideline-based cancer screening in order to reduce the burden of CRC among high-risk individuals living in a persistent poverty county through targeted, culturally-sensitive navigation that addresses social factors that prevent CRC screening.

Study Type

Observational

Enrollment (Actual)

385

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The cohort will consist of patients residing in 18 zip codes in Western and Southwestern Philadelphia who have primary care providers in 4 Penn Medicine Internal Medicine practices and 3 Penn Medicine Family Medicine Practices. Patients will have had a colonoscopy order placed in the past 6 months and have not scheduled, cancelled, or no-showed to their colonoscopy.

Description

Inclusion Criteria:

  • Patients residing in 18 zip codes in Western and Southwestern Philadelphia who have primary care providers in 4 Penn Medicine Internal Medicine practices and 3 Penn Medicine Family Medicine Practices
  • Patients who have had a colonoscopy order placed in the past 6 months and have not scheduled, cancelled, or no-showed to their colonoscopy

Exclusion Criteria:

  • Not applicable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients Residing in 18 zip codes in Western and Southwestern Philadelphia
The cohort will consist of patients residing in 18 zip codes in Western and Southwestern Philadelphia who have primary care providers in 4 Penn Medicine Internal Medicine practices and 3 Penn Medicine Family Medicine Practices.
This intervention will utilize the existing Penn Medicine CRC patient navigation program. There will be a monthly list of patients with unfilled coloscopies provided, that are risk-stratified according to the machine learning algorithm and select high-risk criteria. The navigation team will prioritize timely outreach and navigation to high-risk patients according to a script that communicates risk.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enrollment in Navigator Program (Feasibility)
Time Frame: During the three month enrollment period
Number of patients that participate in the navigation program
During the three month enrollment period
Completion of Colorectal Cancer Screening
Time Frame: Within the three month enrollment period and three month follow-up period
Number of patients that have completed their colonoscopy or Fecal Immunochemical Test (FIT)
Within the three month enrollment period and three month follow-up period
Number of Participants With Adenoma Detection
Time Frame: Within the three month enrollment period and three month follow-up period
Rate of adenomas after completion of colonoscopy
Within the three month enrollment period and three month follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Carmen Guerra, MD, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2022

Primary Completion (Actual)

November 1, 2024

Study Completion (Actual)

November 1, 2024

Study Registration Dates

First Submitted

May 17, 2022

First Submitted That Met QC Criteria

May 17, 2022

First Posted (Actual)

May 20, 2022

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

November 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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