A Multilevel Intervention to Increase Colorectal Cancer Screening Tests in Patients With Abnormal Fecal Immunochemical Test Results, PROACT Trial
Fred Hutchinson Cancer Center · with National Cancer Institute (NCI) · NCT06822530
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 45–75 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 682
- US sites recruiting
- 1
- Study start
- December 16, 2025
- Record last updated
- June 22, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Best Practice; Educational Intervention; Electronic Health Record Review; Interview; Supportive Care; Survey Administration
Conditions: Colorectal Carcinoma
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- PATIENTS: Age >= 45 years old and =\< 75 years old
- PATIENTS: Receives care at an Harborview Medical Center (HMC) or University of Washington-Kent-Des Moines (UW-KDM) or University of Washington- Federal Way (UW-Federal Way) primary care clinic
- PATIENTS: >= 1 month from documented abnormal FIT result
- PATIENTS: Has not received a colonoscopy between the abnormal FIT and enrollment
- CLINIC STAFF: HMC, UW-Federal Way, or UW-KDM physician or staff member who provides primary care or gastroenterology care
- CLINIC STAFF: Staff in the Fred Hutchinson (Fred Hutch)/UW Medicine Population Health Program that provide colorectal cancer screening and navigation
Recruiting US locations
Fred Hutch/University of Washington Cancer Consortium
Seattle, WA 98109
Site contact: Rachel B. Issaka, MD, MAS · 206-667-1447 · rissaka@fredhutch.org
Study contacts (from the official record)
- Rachel B. Issaka, MD, MAS · 206-667-1447 · rissaka@fredhutch.org
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