NCT06822530 · Fred Hutchinson Cancer Center
A Multilevel Intervention to Increase Colorectal Cancer Screening Tests in Patients With Abnormal Fecal Immunochemical Test Results, PROACT Trial
What this 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.
View original scientific description
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.
Interventions
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
Primary outcome measures
Rate of colonoscopy completion within 6 months
Time frame: At 6 months after randomization
Will descriptively compare the rates of colonoscopy completion at 6 months. Will fit a generalized mixed effects model with a logit link and a random effect for clinic. Will include an indicator variable for the randomized group (usual care versus (vs.) multilevel intervention) and adjust for patient-level clinical and demographic factors (e.g., age, sex, race, ethnicity, primary language, marital status, last primary care visit, insurance) and clinic-level factors (e.g., clinic size, average full-time equivalent providers per clinic, average provider panel size, primary care provider mix (Doctor of Medicine/Doctor of Osteopathic Medicine vs. other advanced degree).
Time to colonoscopy completion
Time frame: Beginning 6 months after randomization until study completion
Will assess the time to colonoscopy completion in days and compare these times across individual clinics.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Seattle, Washington
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 22, 2026 · Source of record for eligibility and locations