Texas Hepatocellular Carcinoma Consortium (THCCC) Project 5

Last updated: September 27, 2022
Sponsor: University of Texas Southwestern Medical Center
Overall Status: Completed

Phase

N/A

Condition

Digestive System Neoplasms

Liver Cancer

Primary Biliary Cholangitis

Treatment

N/A

Clinical Study ID

NCT02582918
062015-054
  • Ages > 21
  • All Genders

Study Summary

Project 5 of the Texas HCC Consortium (THCCC) is a comparative effectiveness pragmatic randomized control trial (RCT) of outreach strategies to increase hepatocellular cancer (HCC) surveillance process completion among a socioeconomically and racially diverse cohort of Texans with cirrhosis. Through this project the investigators will implement and evaluate system-level mailed outreach interventions to identity at-risk patients with cirrhosis, promote HCC surveillance, and ensure timely follow-up of tests at UT Southwestern (UTSW) Medical Center, Parkland Health and Hospital System (PHHS), and the Houston Veterans Affairs (VA) Medical Center. The study population will include adult patients with documented or unrecognized cirrhosis and at least one outpatient clinic visit in year prior to randomization. Patients will be identified using an EMR-enabled case identification algorithm. The investigators will randomize 3000 patients (1500 per arm) identified by this algorithm to: usual care, with opportunistic visit-based HCC surveillance (Group 1); or, mailed HCC surveillance outreach with patient education and patient navigation services (Group 2).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients (>21 years old)
  • Documented cirrhosis
  • Unrecognized cirrhosis
  • An outpatient visit in year prior to randomization
  • English or Spanish speaking

Exclusion

Exclusion Criteria:

  • History of HCC
  • History of liver transplantation
  • Child Pugh C cirrhosis
  • Significant comorbid conditions with life expectancy < 1 year, (e.g., extrahepaticmalignancy)

Study Design

Total Participants: 2871
Study Start date:
March 26, 2018
Estimated Completion Date:
June 30, 2022

Study Description

Hepatocellular cancer (HCC) is the most common (≥ 95%) of liver cancers. HCC is also the fastest rising cause of cancer-related deaths in the U.S. HCC is particularly important for Texas residents. Texas has the second highest death rate from HCC in the nation. The 5-year HCC survival remains low (10-15%) and most patients get diagnosed at late stages. Texas residents notably Hispanics and African Americans are greatly affected with established HCC risk factors including hepatitis C virus, hepatitis B virus and alcoholic liver disease. Furthermore, emerging HCC risk factors, specifically the metabolic syndrome and non-alcoholic fatty liver disease (NAFLD), are exceptionally common in Texans.

The goal of the Texas Hepatocellular Carcinoma Consortium (THCCC) is to reduce the death and suffering related to liver cancer in Texas and the world through five research projects.

This protocol outlines Project 5 of the THCCC which is a comparative effectiveness randomized controlled trial of strategies to increase HCC surveillance. This is the first multi-center outreach intervention aimed at improving surveillance process completion among at-risk patients with cirrhosis.

This study is based at 3 health systems in Texas: UT Southwestern (UTSW) Medical Center, Parkland Health and Hospital System (PHHS), and the Houston Veterans Affairs (VA) Medical Center. Across these 3 sites, we will implement and evaluate system-level mailed outreach interventions to identity at-risk patients with cirrhosis, promote HCC surveillance, and ensure timely follow-up of tests. This study uses an EMR-enabled case-finding algorithm to identify patients with documented cirrhosis, using ICD-9 codes, and those with unrecognized cirrhosis, using laboratory data.

Over 3000 patients identified by this algorithm will be randomized to:

  • Group 1: Usual care with opportunistic visit-based HCC surveillance.

  • Group 2: Mailed HCC surveillance outreach with patient education and patient navigation services.

The Specific Aims are:

  • Aim 1: Compare the clinical effectiveness of the intervention strategies to increase completion of the HCC surveillance process.

  • Aim 2: Compare patient-reported satisfaction and acceptability of the HCC surveillance strategies.

  • Aim 3: Evaluate whether intervention effects are moderated by patient sex, race/ethnicity, socioeconomic status, health care utilization, and documented vs. unrecognized cirrhosis.

Connect with a study center

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.