Clinical trial NCT06635694: naVIGation Invitations Liver surveillANce upTake
Official title: naVIGation Invitations Liver surveillANce upTake
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Liver Cirrhosis
Chronic Hep B
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: RM Partners
First posted: 2024-10-10
Enrollment: 652
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving 6-monthly ultrasound surveillance for HCC

Brief summary: This study aims to evaluate the efficacy of Patient Navigators and mailed surveillance invitations on attendance of Hepatocellular Carcinoma (HCC) ultrasound surveillance appointments. The investigators hypothesise that mailed invitations and Patient Navigators will improve attendance at HCC surveillance appointments and increase the proportion of patients diagnosed at an early stage, compared with a control group receiving usual care.

Detailed description: Hepatocellular carcinoma (HCC) is the third leading cause of cancer-related death worldwide. Despite advances in treatment options, prognosis remains worrying, with 5-year survival rates remaining less than 20%.

Surveillance for HCC involves six-monthly ultrasounds (US) of the liver and has been demonstrated to increase rate of early diagnosis, which translates to improved survival. However, the uptake of HCC surveillance is low internationally; in Western countries, only 20% of patients eligible for HCC surveillance receive a surveillance test.

The current provision of HCC surveillance in the UK is ad hoc: eligible patients have six-monthly ultrasound requested by their clinician (usually a gastroenterologist, hepatologist or hepatology clinical nurse specialist). Patients receive an ultrasound appointment in the post with no formal invitation or information about the surveillance test. Work with focus groups suggests lack of knowledge and fear are barriers to HCC surveillance attendance.

Previous research has shown that patient navigation increased HCC surveillance uptake in an American population. However, there has been no research on interventions aimed at improving surveillance uptake in the UK population.

The study predicts that the mailed invitations and Patient Navigators will improve patient attendance at HCC surveillance and increases the number of patients diagnosed with early-stage HCC, compared with usual care.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* ECOG performance status of 0-2
* Eligible for HCC surveillance as defined by NICE and EASL criteria
* Child Pugh A or B cirrhosis
* Child Pugh C cirrhosis AND on liver transplant waiting list
* High risk chronic hepatitis B

Exclusion Criteria:

* Previous or current diagnosis of HCC
* Child Pugh C cirrhosis
* Frailty (Clinical Frailty Scale \>7)
* Previous liver transplant

Primary outcomes:
measure: Attendance rates at 6-months intervals
timeFrame: 2 years
measure: Proportion of patients in each arm attending HCC surveillance regularly
timeFrame: 2 years
Secondary outcomes:
measure: Proportion of patients in each arm diagnosed with HCC compared with late-stage HCC
timeFrame: 2 years
measure: Cost of intervention compared to standard of care
timeFrame: 2 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
References: