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 | Enrolling By Invitation

• 2 other identifiers: 09225858875
• Study Type: interventional
• Target: 7,120
• Locations: 1 country
• Sites: 1

Brief 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

Colorectal Cancer

Outcome Measures

Primary Outcomes (3)

• Enrollment in the Navigator program

  The patient navigation will assist in completing their colorectal cancer screening. The only test are either a fecal immunochemical test (FIT) or a colonoscopy. No other tests are required.

  12 month

• Completion of colonoscopy or FIT testing

  The patient navigation will assist in completing either a fecal immunochemical test (FIT) or a colonoscopy. The only test are either a fecal immunochemical test (FIT) or a colonoscopy. No other tests are required.

  12 month

• Abnormal screening findings (positive FIT, abnormal colonoscopy findings). S

  We will evaluate the effectiveness of the program on uptake of navigation and completion of CRC screening, rates of abnormal screening results, abnormal stool test follow-up with diagnostic colonoscopy, time to screening uptake, and CRC and precancerous lesion detection.

  12 month

Secondary Outcomes (2)

• Screening uptake

  Firtst 3 month

• Colonoscopy follow-up for abnormal FIT

  Firtst 3 month

Study Arms (2)

Intervention Arm - Navigator Assistance

EXPERIMENTAL

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.

Other: Intervention Arm

Control Arm - NO Navigator Assistance

NO INTERVENTION

Patients in the control arm will be enrolled under a waiver. They will only receive standard of care.

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.

Also known as: Patient navigator

Intervention Arm - Navigator Assistance

Eligibility Criteria

• Age: 45 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 45-49
• Not up to date with CRC screening within the recommended period of time (colonoscopy within 10 years, FIT within 1 year, Cologuard within 3 years, sigmoidoscopy within 3-5 years)
• Have primary care providers in Penn Internal Medicine and Family Medicine Practices
• Have at least 1 outpatient CBC in the past 12 months.

You may not qualify if:

• Prior history of CRC
• Late-stage cancer of any organ (stage 4)
• History of colectomy
• Demonstrated high-risk of colorectal cancer (e.g. inflammatory bowel disease, hereditary colorectal cancer syndromes)

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19003, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: November 17, 2025
• Study Start: September 29, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)