Clinical trial NCT06822530: A Multilevel Intervention to Increase Colorectal Cancer Screening Tests in Patients With Abnormal Fecal Immunochemical Test Results, PROACT Trial
Official title: PROACT: Promoting Follow-Up of Abnormal Colorectal Cancer Screening Tests Through Multilevel Interventions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Carcinoma
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 682
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of colonoscopy completion within 6 months
timeFrame: At 6 months after randomization
measure: Time to colonoscopy completion
timeFrame: Beginning 6 months after randomization until study completion
Secondary outcomes:
measure: Rate of colonoscopy completion > 6 months
timeFrame: At 9 and 12 months after randomization
measure: Colonoscopy referral: Number of participants referred for a colonoscopy
timeFrame: Up to 18 months after randomization
measure: Time to colonoscopy referral (days)
timeFrame: Up to 18 months after randomization
measure: Number of participants who schedule a colonoscopy
timeFrame: Up to 18 months after randomization
measure: Time to scheduling a colonoscopy (days)
timeFrame: Up to 18 months after randomization
measure: Time from abnormal fecal immunochemical test (FIT) result to colonoscopy completion
timeFrame: Up to 18 months after randomization
measure: Rates of colorectal cancer or advanced adenoma
timeFrame: Up to 18 months after randomization
measure: Proportion and demographic characteristics of individuals who are eligible and receive the multilevel intervention after randomization (Reach)
timeFrame: 6-24 months post randomization
measure: Perception that the intervention components are suitable to address identified barriers (Acceptability)
timeFrame: 6-24 months post randomization
measure: Degree to which the intervention is used as intended (Fidelity)
timeFrame: 6-24 months post randomization
measure: Average cost per patient to deliver the intervention
timeFrame: Weekly, for up to 8 months
measure: Average cost per clinic to deliver the intervention
timeFrame: Weekly, for up to 8 months
measure: Proportion of costs per intervention activity
timeFrame: Weekly, for up to 8 months
measure: Number of participants served per intervention component
timeFrame: Weekly, for up to 8 months
measure: Average cost per participant by intervention component
timeFrame: Weekly, for up to 8 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Rachel B. Issaka, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: