NCT05383976

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
385

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

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

Study Start

First participant enrolled

March 29, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

February 11, 2026

Completed
Last Updated

February 11, 2026

Status Verified

November 1, 2024

Enrollment Period

2.6 years

First QC Date

May 17, 2022

Results QC Date

November 17, 2025

Last Update Submit

February 10, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Enrollment in Navigator Program (Feasibility)

    Number of patients that participate in the navigation program

    During the three month enrollment period

  • Completion of Colorectal Cancer Screening

    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

    Rate of adenomas after completion of colonoscopy

    Within the three month enrollment period and three month follow-up period

Study Arms (1)

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.

Other: Machine Learning Algorithm with Existing Penn Medicine CRC Patient Navigation Program

Interventions

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.

Patients Residing in 18 zip codes in Western and Southwestern Philadelphia

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Machine Learning Algorithms

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AlgorithmsMathematical Concepts

Results Point of Contact

Title
Yvette Frimpong
Organization
Abramson Cancer Center at Penn Medicine

Study Officials

  • Carmen Guerra, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

May 17, 2022

First Posted

May 20, 2022

Study Start

March 29, 2022

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

February 11, 2026

Results First Posted

February 11, 2026

Record last verified: 2024-11

Locations