NCT06822530

A Multilevel Intervention to Increase Colorectal Cancer Screening Tests in Patients With Abnormal Fecal Immunochemical Test Results, PROACT Trial

PROACT: Promoting Follow-Up of Abnormal Colorectal Cancer Screening Tests Through Multilevel Interventions

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 682 (estimated)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

This clinical trial studies whether an intervention that addresses two or more levels of care (multilevel intervention) increases follow-up of abnormal, non-invasive, colorectal cancer (CRC) screening test results. The fecal immunochemical test (FIT) is a non-invasive, stool-based, CRC screening test. FITs are relatively inexpensive and can be completed at home, for these reasons, it is a preferred method of CRC screening in healthcare settings that care for under-resourced patients or have limited colonoscopy access. For FIT-based CRC screening to be effective, abnormal results must be followed by a colonoscopy, however many patients fail to complete this recommended follow-up test. The multilevel intervention addresses barriers to follow-up colonoscopy at the patient and health system levels of care through a CRC screening patient navigator, an educational video, and transportation assistance. The navigator provides patient support and assistance with colonoscopy scheduling. The educational video addresses identified patient fears around colonoscopies. Transportation assistance is offered after the colonoscopy through a rideshare program to address transportation barriers. Therefore, this multilevel intervention may increase follow-up colonoscopy completion in patients with abnormal FIT results.

Detailed description

OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive usual care from the CRC screening program navigator which includes monthly phone calls with the CRC screening program navigator, and assistance with colonoscopy scheduling. GROUP II: Patients receive usual care as described in Group I and additionally receive a quick response (QR) code with a link to a video to address patient-level fears of colonoscopy screening via text message, mailed letter, or EHR platform as well as access to transportation home after colonoscopy via a rideshare program arranged through the discharge nurse. After completion of study intervention, patients are followed up for 18 months.

Conditions

• Colorectal Carcinoma

Interventions

Type	Name	Description
OTHER	Best Practice	Receive usual care CRC screening program navigation
OTHER	Educational Intervention	Receive QR code and link to video addressing fears of colonoscopy
OTHER	Electronic Health Record Review	Ancillary studies
OTHER	Interview	Ancillary studies
OTHER	Supportive Care	Receive rideshare transportation home after colonoscopy
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2025-12-16
• Primary completion: 2028-06-30
• Completion: 2029-11-30
• First posted: 2025-02-12
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States