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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT07230795
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 49 Years
Healthy Volunteers
Not accepted

Interventions

  • Intervention Arm — OTHER
    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.

Study Details

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.

Key Dates

Start date
Sep 29, 2025
Status verified
Oct 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
7,120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Intervention Arm - Navigator Assistance
    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.
  • No Intervention: Control Arm - NO Navigator Assistance
    Patients in the control arm will be enrolled under a waiver. They will only receive standard of care.

Primary Outcome Measure

Enrollment in the Navigator program [ Time Frame: 12 month ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19003-

Find similar trials in Philadelphia, PA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
University of Pennsylvania· Philadelphia, PA

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