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

Not Applicable

Not yet recruiting

• Conditions: Colorectal Carcinoma

• Registration Number: NCT06822530
• Lead Sponsor: Fred Hutchinson Cancer Center

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.

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 Timeline

• Study First Submitted: 2025-01-27
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-06
• Study First Posted: 2025-02-12
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-11
• Study Start: 2025-09-01
• Primary Completion: 2028-06-30
• Study Completion: 2029-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 682

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of colonoscopy completion within 6 months	At 6 months after randomization	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).
Time to colonoscopy completion	Beginning 6 months after randomization until study completion	Will assess the time to colonoscopy completion in days and compare these times across individual clinics.

Secondary Outcome Measures

Name	Time	Method
Rate of colonoscopy completion > 6 months	At 9 and 12 months after randomization	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.
Colonoscopy referral: Number of participants referred for a colonoscopy	Up to 18 months after randomization	Will assess colonoscopy referral (yes/no) as the number of participants who have a colonoscopy referral placed after randomization.
Time to colonoscopy referral (days)	Up to 18 months after randomization	Will assess the number of days from randomization to colonoscopy referral.
Number of participants who schedule a colonoscopy	Up to 18 months after randomization	Will assess the number of referred participants who schedule a colonoscopy.
Time to scheduling a colonoscopy (days)	Up to 18 months after randomization	Will assess the number of days from randomization to a colonoscopy being scheduled.
Time from abnormal fecal immunochemical test (FIT) result to colonoscopy completion	Up to 18 months after randomization	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.
Rates of colorectal cancer or advanced adenoma	Up to 18 months after randomization	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.
Proportion and demographic characteristics of individuals who are eligible and receive the multilevel intervention after randomization (Reach)	6-24 months post randomization	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.
Perception that the intervention components are suitable to address identified barriers (Acceptability)	6-24 months post randomization	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.
Degree to which the intervention is used as intended (Fidelity)	6-24 months post randomization	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.
Average cost per patient to deliver the intervention	Weekly, for up to 8 months	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.
Average cost per clinic to deliver the intervention	Weekly, for up to 8 months	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.
Proportion of costs per intervention activity	Weekly, for up to 8 months	Will calculate the proportion of costs that can be attributed to each intervention activity.
Number of participants served per intervention component	Weekly, for up to 8 months	The number of participants served per intervention component.
Average cost per participant by intervention component	Weekly, for up to 8 months	Will calculate an average per-participant activity cost for each intervention component.

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States