MedTrace Logo

AI-informed Colorectal Cancer (CRC) Screening Navigation vs. Standard of Care Among Screening-naive Penn Medicine Patients 45-49 Years Old to Increase CRC Screening Uptake

NCT07230795 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7120

Last updated 2025-11-17

No results posted yet for this study

Summary

This project aims to use machine learning algorithms (MLA) to identify and risk-stratify individuals between the ages of 45-49 who are more likely to have colorectal pathology and merit prioritized CRC screening and patient navigation. Patients deemed to be at higher risk for CRC by MLA will be randomized to an intervention group to receive risk-informed patient navigation and a usual care control group. The patient navigation will assist in completing either a fecal immunochemical test (FIT) or a colonoscopy. For the usual care control group, patients may still receive patient navigation for colonoscopy assistance. A referral to a nurse navigator can be initiated by a healthcare staff member in the following ways: 1) procedure scheduling staff will provide navigator's contact number if the patient expresses difficulty with obtaining a ride home 2) endoscopy staff and physicians can message navigator electronically 3) PCPs can place a navigation order in the EHR for patients deemed to need additional support such as with prep, education, transportation 4) providers will directly contact the director of the navigation system (Dr. Carmen Guerra) for referral.

Conditions

Interventions

OTHER

Intervention Arm

The intervention arm will consist of a trained CRC navigator who will conduct outreach and navigation by interviewing these patients according to a script that consists of a statement of research, confirms eligibility, communicates their relative increased risk of CRC, assesses and addresses barriers to completion of CRC screening, and offers an adapted validated questionnaire regarding these barriers for patients to complete asynchronously. The navigator will be able to address barriers such as lack of awareness/knowledge about screening, misinformation, negative attitudes and fear, scheduling, inability to afford the prep, and lack of transportation and escort. The calls performed by the patient navigator will not be recorded.

Sponsors & Collaborators

  • Abramson Cancer Center at Penn Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-29
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07230795 on ClinicalTrials.gov