Multilevel Intervention for Colorectal Cancer

Recruiting in Palo Alto (17 mi)

Overseen byRachel B. Issaka, MD, MAS

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Fred Hutchinson Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for patients with abnormal non-invasive colorectal cancer screening results who haven't followed up with a colonoscopy. It's designed to help those in under-resourced areas or with limited access to colonoscopies, by addressing patient and health system barriers.

Inclusion Criteria

Patients receiving care at Harborview Medical Center (HMC) or University of Washington-Kent-Des Moines (UW-KDM) primary care clinic

Patients at least 1 month from documented abnormal FIT result

Patients who have not received a colonoscopy between the abnormal FIT and enrollment

+3 more

Participant Groups

The PROACT Trial tests a multilevel intervention including support from a CRC screening navigator, an educational video about colonoscopies, and rideshare transportation post-procedure. The goal is to see if these combined efforts increase the rate of follow-up colonoscopies.

2Treatment groups

Experimental Treatment

Active Control

Group I: Group II (usual care, video, rideshare transportation)Experimental Treatment6 Interventions

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.

Group II: Group I (usual care)Active Control2 Interventions

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.