Fred Hutchinson Cancer Center
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.
Colorectal Carcinoma
Best Practice
Educational Intervention
Electronic Health Record Review
Interview
Supportive Care
Survey Administration
NA
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.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 682 participants |
| Masking : | SINGLE |
| Masking Description : | The program navigator will be blinded to randomization assignments. |
| Primary Purpose : | SCREENING |
| Official Title : | PROACT: Promoting Follow-Up of Abnormal Colorectal Cancer Screening Tests Through Multilevel Interventions |
| Actual Study Start Date : | 2025-09-01 |
| Estimated Primary Completion Date : | 2028-06-30 |
| Estimated Study Completion Date : | 2029-11-30 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109