N/A
N=615
Hepatocellular Carcinoma Surveillance in Cirrhotics
Hepatocellular Carcinoma · Cirrhosis
Bottom Line
View on ClinicalTrials.gov: NCT04248816 ↗Enrolled (actual)
615
Serious AEs
—
Results posted
Feb 2023
Primary outcome: Primary: HCC Screening Completion — 27.6; 54.5; 54.1 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Usual care (Behavioral); Opt-out (Behavioral); Opt-out + Incentive (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HCC Screening Completion |
27.6; 54.5; 54.1 | — |
| SECONDARY HCC Screening Method |
32.8; 59.4; 57.2 | — |
Summary
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04248816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.