# Efficacy of mailed surveillance invitations and telephone patient navigation to improve hepatocellular carcinoma surveillance uptake: study protocol of VIGILANT—a single-centre, two-arm randomised controlled trial

## TL;DR

This study tests if mailing invitations and using patient navigators can improve attendance for liver cancer screening in high-risk patients.

## Contribution

The study introduces a co-designed outreach strategy combining mailed invitations and patient navigators to boost HCC surveillance.

## Key findings

- The trial will assess if patient navigators improve attendance rates for HCC surveillance.
- It will compare the cost-effectiveness of two outreach strategies for HCC screening.
- Early-stage HCC diagnosis rates will be evaluated as a secondary outcome.

## Abstract

Hepatocellular carcinoma (HCC) is a leading cause of cancer-related mortality, and mortality rates have continued to rise despite advancements in treatment. Six-monthly ultrasound surveillance is recommended by professional bodies for early detection of HCC in high-risk cohorts. However, surveillance rates remain poor; only 20% of patients attend for regular surveillance. Population health outreach strategies may be able to enhance surveillance rates by addressing patient-related barriers to engagement with healthcare. Using a co-design approach, we have developed outreach material in tandem with patients, with the aim of boosting HCC surveillance. VIGILANT aims to compare the effectiveness of bespoke mailed surveillance invitations with or without patient navigators (PNs) in improving attendance rates at surveillance appointments.

This is a two-arm randomised controlled trial that will recruit 652 participants. Participants will be patients with chronic liver disease or cirrhosis, who are eligible for HCC surveillance as defined by criteria from the National Institute for Health and Care Excellence and European Association for the Study of the Liver. Participants will be randomised (in a 1:1 ratio) to receive either (a) a mailed surveillance invitation or (b) a mailed invitation plus telephone call reminder from a PN 1 week prior to the appointment. The primary objective is to evaluate the impact of PNs and mailed invitations on attendance rates. Secondary objectives include rates of diagnosis of early-stage HCC among patients undergoing surveillance and cost-effectiveness of each arm.

Approval has been sought to conduct the research from Aberdeen Research Ethics Committee (REC Reference: 335338). The study is sponsored by Imperial College London and funded by RM Partners (West London Cancer Alliance). Study findings will be presented at medical conferences and published in peer-reviewed journals.

NCT06635694.