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Completed

NCT Number: NCT04248816

Hepatocellular Carcinoma Surveillance in Cirrhotics

This is a 3-arm pilot randomized controlled trial applying behavioral economic approaches (opt-out framing and financial incentives) to encourage patients with liver cirrhosis to complete regular surveillance ultrasounds which may allow for earlier diagnosis of and better outcomes for hepatocellular carcinoma (HCC).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

About this study

There is a substantial burden of HCC-related morbidity and mortality: The age-adjusted incidence rates of HCC have tripled in the US since the 1980s due to the burden of hepatitis C virus (HCV) and the epidemic of non-alcoholic fatty liver disease (NAFLD). The overwhelming majority of HCC in the US occurs in the setting of cirrhosis. Early diagnosis of HCC dictates survival: The American Association for the Study of Liver Diseases (AASLD) recommends biannual HCC surveillance for all patients with cirrhosis using an abdominal ultrasound. These guidelines seek to maximize early diagnosis of HCC which leads to earlier detection and improved survival because early-stage HCC is curable, with 70% 5-year survival compared to 5% in advanced disease.

HCC surveillance rates are suboptimal: Despite longstanding published guidelines for HCC surveillance, adherence is low, with surveillance rates ranging from 15-30% in the US. Two RCTs have tested interventions to increase HCC surveillance, including electronic reminders for primary care providers and mailed reminders (with or without navigators), but neither has been scalable, produced durable responses, or increased surveillance rates above 50%.

This is a 3-arm pilot randomized controlled trial applying behavioral economic approaches (opt-out framing and financial incentives) to encourage patients with liver cirrhosis to complete regular surveillance ultrasounds which may allow for earlier diagnosis of and better outcomes for hepatocellular carcinoma (HCC).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who are 18+ years old
  • Current diagnosis of cirrhosis or advanced fibrosis
  • 1 or more visits to a Penn Gastroenterology/Hepatology practice in the preceding two years
  • Currently followed by Penn Gastroenterology/Hepatology
  • Must live in the Philadelphia Metropolitan Statistical Area

Exclusion criteria

  • History of HCC or other liver carcinoma diagnosis
  • History of liver transplant
  • Completed HCC screening within the past 7 months
  • Have a future screening scheduled
  • Have a different screening modality recommended by their physician (MRI, CT, etc.)
  • Patients with metastatic cancer
  • Patients receiving hospice care

Treatment and study plan

Usual Care

Behavioral

Subjects will receive outreach through their providers as is standard of care.

Opt-out

Behavioral

Research staff will send a letter to patients encouraging them to get a surveillance ultrasound and include an order slip for them to get it done at a health system facility.

Opt-out + Incentive

Behavioral

Research staff will send a letter to patients encouraging them to get a surveillance ultrasound and include an order slip plus an unconditional $20 incentive for them to get it done at a health system facility.

Primary outcomes

  1. HCC Screening Completion

    Time frame: 6 months

    The percentage of subjects who have a surveillance abdominal ultrasound.

Secondary outcomes

  1. HCC Screening Method

    Time frame: 6 months

    The percentage of subjects who have any hepatocellular carcinoma surveillance.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Increasing Surveillance Rates for Hepatocellular Carcinoma Among Cirrhotic Patients

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jan 30, 2020
Registry last updated
Feb 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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