Harms of Hepatocellular Carcinoma Surveillance

CompletedOBSERVATIONAL
Enrollment

2,871

Participants

Timeline

Start Date

April 1, 2018

Primary Completion Date

June 30, 2022

Study Completion Date

June 30, 2022

Conditions
Carcinoma, Hepatocellular
Interventions
OTHER

Prospective Longitudinal Data

We will prospectively follow the cohort using electronic medical record to document the hepatocellular carcinoma screening process and characterize physical and financial harms related to positive or indeterminate screening results and burden of inappropriate screening. Patients are anticipated to undergo hepatocellular carcinoma screening every 6-12 months, so each patient will have \~4-8 screening encounters over the study duration. We will use manual chart review to determine intent of ultrasound exams (screening vs. diagnostic) and test results. Receipt of follow-up tests after positive or indeterminate screening results will be identified through electronic medical record extraction using Current Procedural Terminology (CPT) codes for CT, MRI, and biopsy.

OTHER

Surveys and Semi-structured Interviews

"We will use surveys and semi-structured interviews to characterize psychological harms after positive or indeterminate screening tests. Patient surveys will include patient-reported scales to measure psychosocial factors at three times points: baseline, 1 month after screening result, and 4 months after screening result. Semi-structured interviews will be conducted via telephone to explore patient attitudes toward risk perception, test follow-up, competing demands, and downstream harms, particularly financial issues (e.g., out-of-pocket costs, access to insurance, and juggling hepatocellular carcinoma screening process completion with competing demands-work and family)."

Trial Locations (1)

75390

University of Texas Southwestern Medical Center, Dallas

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

Parkland Health and Hospital System

OTHER

collaborator

Baylor College of Medicine

OTHER

collaborator

Michael E. DeBakey VA Medical Center

FED

collaborator

Kaiser Permanente

OTHER

lead

University of Texas Southwestern Medical Center

OTHER

NCT03756051 - Harms of Hepatocellular Carcinoma Surveillance | Biotech Hunter | Biotech Hunter