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

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT06822530
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 16, 2025
Status verified
Jun 2026
Primary completion
Jan 31, 2030
Completion
Jan 31, 2030

Study Design

Enrollment
682 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Active Comparator: Group I (usual care)
    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.
  • Experimental: Group II (usual care, video, rideshare transportation)
    Patients receive usual care as described in Group I and additionally receive a 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 on study.

Primary Outcome Measure

Rate of colonoscopy completion within 6 months [ Time Frame: At 6 months after randomization ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109-

Find similar trials in Seattle, WA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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