Recruiting

Multilevel Intervention

Sponsor:

Fred Hutchinson Cancer Center

Code:

NCT06822530

Conditions

Colorectal Carcinoma

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Interventions

Best Practice

Educational Intervention

Electronic Health Record Review

Interview

Supportive Care

Study Details

Brief summary:

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.

Conditions

Colorectal Carcinoma

Study ID

NCT06822530

Start date

Dec 16, 2025

Status verified date

Jun, 2026

Completion date

Jan 31, 2030

Anticipated

Primary completion date

Jan 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

682 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

active comparator: Group I (usual care)

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.

experimental: Group II (usual care, video, rideshare transportation)

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.

Interventions

Best Practice

Receive usual care CRC screening program navigation

Educational Intervention

Receive QR code and link to video addressing fears of colonoscopy

Electronic Health Record Review

Ancillary studies

Interview

Ancillary studies

Supportive Care

Receive rideshare transportation home after colonoscopy

Survey Administration

Ancillary studies

Primary outcome measure

  • Rate of colonoscopy completion within 6 months [ Time Frame: At 6 months after randomization ]
  • Time to colonoscopy completion [ Time Frame: Beginning 6 months after randomization until study completion ]

Central Contacts and Locations

Central contacts

Rachel B. Issaka, MD, MAS

206-667-1447rissaka@fredhutch.org

Locations

Fred Hutch/University of Washington Cancer Consortium

Recruiting

Seattle, Washington, United States, 98109

Contacts

Rachel B. Issaka, MD, MAS

206-667-1447rissaka@fredhutch.org

Principal Investigator:

Rachel B. Issaka, MD, MAS

More Information

Sponsor

Fred Hutchinson Cancer Center

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fred Hutchinson Cancer Center on 2026-06-22.