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PROACT: Promoting Follow-Up of Abnormal Colorectal Cancer Screening Tests Through Multilevel Interventions
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.
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.
Age
All ages
Sex
ALL
Healthy Volunteers
Yes
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Start Date
December 16, 2025
Primary Completion Date
June 30, 2028
Completion Date
November 30, 2029
Last Updated
February 17, 2026
682
ESTIMATED participants
Best Practice
OTHER
Educational Intervention
OTHER
Electronic Health Record Review
OTHER
Interview
OTHER
Supportive Care
OTHER
Survey Administration
OTHER
Lead Sponsor
Fred Hutchinson Cancer Center
Collaborators
NCT04704661
NCT06349642
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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