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

PROACT: Promoting Follow-Up of Abnormal Colorectal Cancer Screening Tests Through Multilevel Interventions

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Colorectal Carcinoma
• Intervention / Treatment: Other: Survey Administration; Other: Interview; Other: Electronic Health Record Review; Other: Best Practice; Other: Educational Intervention; Other: Supportive Care

Detailed Description

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
• Enrollment (Estimated): 682
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Electronic Health Record Review; Ancillary studies; Other: Best Practice; Receive usual care CRC screening program navigation; Other Names: standard of care; standard therapy
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.	Other: Survey Administration; Ancillary studies; Other: Interview; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Other: Best Practice; Receive usual care CRC screening program navigation; Other Names: standard of care; standard therapy; Other: Educational Intervention; Receive QR code and link to video addressing fears of colonoscopy; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Supportive Care; Receive rideshare transportation home after colonoscopy; Other Names: Supportive Therapy; Symptom Management; Therapy, Supportive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of colonoscopy completion > 6 months	Will fit separate generalized mixed effects model for each binary outcome, with a logit link and a random effect for clinic. In all models, will include an indicator variable for the randomized group and adjust for patient-level clinical and demographic factors and clinic-level factors.	At 9 and 12 months after randomization
Colonoscopy referral: Number of participants referred for a colonoscopy	Will assess colonoscopy referral (yes/no) as the number of participants who have a colonoscopy referral placed after randomization.	Up to 18 months after randomization
Time to colonoscopy referral (days)	Will assess the number of days from randomization to colonoscopy referral.	Up to 18 months after randomization
Number of participants who schedule a colonoscopy	Will assess the number of referred participants who schedule a colonoscopy.	Up to 18 months after randomization
Time to scheduling a colonoscopy (days)	Will assess the number of days from randomization to a colonoscopy being scheduled.	Up to 18 months after randomization
Time from abnormal fecal immunochemical test (FIT) result to colonoscopy completion	Will assess the time from abnormal FIT results to colonoscopy completion (days). Will fit separate generalized mixed effects model for each binary outcome, with a logit link and a random effect for clinic. For time-to-event secondary outcomes, will fit separate Cox proportional hazards regression models where the outcomes will be measured in days. In all models, will include an indicator variable for the randomized group and adjust for patient-level clinical and demographic factors and clinic-level factors.	Up to 18 months after randomization
Rates of colorectal cancer or advanced adenoma	Will assess the number of colorectal cancers or advanced adenomas detected as reported in pathology reports. Colorectal cancer will be defined as a histologically confirmed invasive carcinoma or minimally invasive carcinoma. Advanced adenoma will be defined as a tubular adenoma > or = 10mm, villous, or high-grade dysplasia.	Up to 18 months after randomization
Proportion and demographic characteristics of individuals who are eligible and receive the multilevel intervention after randomization (Reach)	Participant demographics and quantitative measures of implementation outcomes (reach) will be reported as proportions or medians and interquartile ranges (IQRs). Average scores of the implementation outcomes will be reported per participant and clinic. Will assess differences between groups using chi-square, Student's t-test or Wilcoxon tests, as appropriate.	6-24 months post randomization
Perception that the intervention components are suitable to address identified barriers (Acceptability)	Participant demographics and quantitative measures of implementation outcomes (acceptability) will be reported as proportions or medians and IQRs. Average scores of the implementation outcomes will be reported per participant and clinic. Will assess differences between groups using chi-square, Student's t-test or Wilcoxon tests, as appropriate. Semi-structured interviews will be transcribed verbatim, verified against recordings, and uploaded to the data management software by participant number. Will apply a hybrid approach to the data analysis by combining inductive and deductive methods. Using a convergent parallel mixed-methods approach, will integrate and analyze quantitative and qualitative data, according to the Predisposing, Reinforcing, and Enabling Constructs in Educational Diagnosis and Evaluation model that analyzes data at multiple ecological levels and is particularly relevant for the study.	6-24 months post randomization
Degree to which the intervention is used as intended (Fidelity)	Will be assessed by the proportion and demographic characteristics of individuals who use all components of the intervention after randomization, complete adherence to the program protocol, and quality of the program delivery. Participant demographics and quantitative measures of implementation outcomes (fidelity) will be reported as proportions or medians and IQRs. Average scores of the implementation outcomes will be reported per participant and clinic. Will assess differences between groups using chi-square, Student's t-test or Wilcoxon tests, as appropriate.	6-24 months post randomization
Average cost per patient to deliver the intervention	Will calculate personnel and operational costs for the multilevel intervention for each patient. Total costs for each component per patient (personnel, materials/supplies, facility fees, training, and professional development) will also be calculated.	Weekly, for up to 8 months
Average cost per clinic to deliver the intervention	Will calculate personnel and operational costs for the multilevel intervention for each clinic. Total costs for each component per clinic (personnel, materials/supplies, facility fees, training, and professional development) will also be calculated.	Weekly, for up to 8 months
Proportion of costs per intervention activity	Will calculate the proportion of costs that can be attributed to each intervention activity.	Weekly, for up to 8 months
Number of participants served per intervention component	The number of participants served per intervention component.	Weekly, for up to 8 months
Average cost per participant by intervention component	Will calculate an average per-participant activity cost for each intervention component.	Weekly, for up to 8 months

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Rachel B. Issaka, MD, MAS, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2025
• Primary Completion (Estimated): January 31, 2030
• Study Completion (Estimated): January 31, 2030

Study Registration Dates

• First Submitted: January 27, 2025
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): February 12, 2025

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Therapeutics; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Quality Indicators, Health Care; Patient Care; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Community Health Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Guidelines as Topic; Quality Assurance, Health Care; Methods; Interviews as Topic; Standard of Care; Palliative Care; Early Intervention, Educational; Educational Status; Practice Guidelines as Topic
• Other Study ID Numbers: RG1124701; NCI-2024-08639 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R37CA295618 (U.S. NIH Grant/Contract); FHIRB0020712 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD to be shared with other researchers: All of the IPD collected during the trial, after deidentification. Supporting information that will be shared will include: Study protocol, analyzable data set, data dictionary/codebook, statistical analysis plan, analytic code, data collection instruments.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No