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OpenTrials
Completed

NCT Number: NCT05383976

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

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).

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Machine Learning Algorithm with Existing Penn Medicine CRC Patient Navigation Program

Other

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.

Primary outcomes

  1. Enrollment in Navigator Program (Feasibility)

    Time frame: During the three month enrollment period

    Number of patients that participate in the navigation program

  2. 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)

  3. 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

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

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

Acronym: PCSNaP

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 20, 2022
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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