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

NCT ID: NCT06822530

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

682 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-16

Study Completion Date

2029-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colorectal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Caregivers
The program navigator will be blinded to randomization assignments.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive usual care CRC screening program navigation

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

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.

Group Type EXPERIMENTAL

Best Practice

Intervention Type OTHER

Receive usual care CRC screening program navigation

Educational Intervention

Intervention Type OTHER

Receive QR code and link to video addressing fears of colonoscopy

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

Interview

Intervention Type OTHER

Ancillary studies

Supportive Care

Intervention Type OTHER

Receive rideshare transportation home after colonoscopy

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Best Practice

Receive usual care CRC screening program navigation

Intervention Type OTHER

Educational Intervention

Receive QR code and link to video addressing fears of colonoscopy

Intervention Type OTHER

Electronic Health Record Review

Ancillary studies

Intervention Type OTHER

Interview

Ancillary studies

Intervention Type OTHER

Supportive Care

Receive rideshare transportation home after colonoscopy

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Supportive Therapy Symptom Management Therapy, Supportive

Eligibility Criteria

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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) 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 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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rachel B. Issaka, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

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Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2024-08639

Identifier Type: REGISTRY

Identifier Source: secondary_id

R37CA295618

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FHIRB0020712

Identifier Type: OTHER

Identifier Source: secondary_id

RG1124701

Identifier Type: -

Identifier Source: org_study_id