A Multilevel Intervention to Increase Colorectal Cancer Screening Tests in Patients With Abnormal Fecal Immunochemical Test Results, PROACT Trial

NCT06822530 | Enrolling By Invitation

• 4 other identifiers: RG1124701NCI-2024-08639R37CA295618FHIRB0020712
• Study Type: interventional
• Target: 682
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Rate of colonoscopy completion within 6 months

  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).

  At 6 months after randomization

• Time to colonoscopy completion

  Will assess the time to colonoscopy completion in days and compare these times across individual clinics.

  Beginning 6 months after randomization until study completion

Secondary Outcomes (15)

• Rate of colonoscopy completion > 6 months

  At 9 and 12 months after randomization

• Colonoscopy referral: Number of participants referred for a colonoscopy

  Up to 18 months after randomization

• Time to colonoscopy referral (days)

  Up to 18 months after randomization

• Number of participants who schedule a colonoscopy

  Up to 18 months after randomization

• Time to scheduling a colonoscopy (days)

  Up to 18 months after randomization

Study Arms (2)

Group I (usual care)

ACTIVE COMPARATOR

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.

Other: Best Practice; Other: Electronic Health Record Review

Group II (usual care, video, rideshare transportation)

EXPERIMENTAL

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.

Other: Best Practice; Other: Educational Intervention; Other: Electronic Health Record Review; Other: Interview; Other: Supportive Care; Other: Survey Administration

Interventions

Electronic Health Record Review OTHER

Ancillary studies

Group I (usual care); Group II (usual care, video, rideshare transportation)

Interview OTHER

Ancillary studies

Group II (usual care, video, rideshare transportation)

Supportive Care OTHER

Receive rideshare transportation home after colonoscopy

Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive

Group II (usual care, video, rideshare transportation)

Survey Administration OTHER

Ancillary studies

Group II (usual care, video, rideshare transportation)

Best Practice OTHER

Receive usual care CRC screening program navigation

Also known as: standard of care, standard therapy

Group I (usual care); Group II (usual care, video, rideshare transportation)

Educational Intervention OTHER

Receive QR code and link to video addressing fears of colonoscopy

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Group II (usual care, video, rideshare transportation)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Early Intervention, Educational; Educational Status; Methods; Interviews as Topic; Palliative Care

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health; Patient Care; Therapeutics

Study Officials

• Rachel B. Issaka, MD, MAS

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The program navigator will be blinded to randomization assignments.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 12, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): November 30, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Complete trial data will be made available no later than 12 months via clinicaltrials.gov after the trial's primary completion date regardless of whether the clinical trial was completed as planned or terminated earlier in compliance with the NCI Clinical Trial Access Policy. Participant data, interview transcripts and underlying primary data for the publications will be made available through Mendeley data repository no later than the time of an associated publication or the end of the performance period, whichever comes first. Data will remain available via Mendeley indefinitely.
• Access Criteria: Public-access data will be available to researchers through the Mendeley website. IPD will be made available to researchers who provide a methodologically sound proposal to achieve the aims in their proposal and obtain approval from an independent review committee. Researchers who wish to use the most sensitive data and/or link project data to other datasets must apply for access through a contract request to use the Mendeley virtual data enclave.

Locations

US (1)