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NCT Number: NCT02582918

Texas Hepatocellular Carcinoma Consortium (THCCC) Project 5

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).

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Key information

Conditions

Carcinoma, Hepatocellular Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Outreach with patient education and patient navigation services

Behavioral
  • Outreach invitations include number to call for more information about scheduling an ultrasound and alpha fetoprotein (AFP) blood test.
  • Patients receive up to three phone calls 2-4 weeks after invitations and a reminder call 5-7 business days before appointments.
  • If results are normal, the patient is invited to repeat screening in 6 months.
  • If suspicious mass on ultrasound or abnormal AFP level, the patient is referred for follow-up testing with triple-phase CT scan or MRI.
  • If CT/MRI is unremarkable, the patient is referred back for routine screening.
  • If HCC is confirmed, the patient and their primary care provider will be contacted with the results.
  • All patients diagnosed with HCC will be seen in the multi-disciplinary HCC clinic.

Primary outcomes

  1. Completion of HCC surveillance process

    Time frame: 3 years post randomization

    Ascertained through EMR.

    HCC surveillance process completion will be defined as:

    • normal ultrasound and AFP every 6 ± 1 months for two consecutive years,
    • abnormal ultrasound or AFP ≥20 ng/mL and follow-up diagnostic CT or MRI without HCC, then appropriate surveillance as indicated for total of 2 years, or
    • abnormal ultrasound or AFP, HCC detected on CT/MRI, and timely HCC treatment consultation.

    Effective surveillance requires repeat testing every 6 months in patients with normal tests to maximize sensitivity while minimizing patient burden.

    Patients with abnormal surveillance tests (i.e. liver mass on ultrasound or AFP ≥20 ng/mL) require 4-phase CT or MRI within 3 months, with a 3-month cut-off based on HCC tumor doubling time.

    Patients with non-contrast imaging, two-phase CT, or imaging > 3 months after abnormal tests will be coded as failure.

    Likewise, patients with HCC confirmed on CT/MRI will need HCC-directed treatment within 3 months.

  2. Patient satisfaction and acceptability

    Time frame: 3 years post randomization

    Assessed by 15-20 minute telephone semi-structured interviews.

    Patients will be called >24 months post-randomization to ensure interviews do not interfere with likelihood of surveillance process completion.

    The investigators will interview 30 completers and 30 non-completers from each group at each site (540 total).

    The investigators will stratify sampling to include both patients with documented cirrhosis and unrecognized cirrhosis. Likert scale items will assess reactions:

    • Participants were confused why they were referred for HCC screening
    • Participants were not given enough information to make a decision
    • Participants don't want to know if they have HCC
    • Information about HCC was new and items assessing if invitations included more, right amount, or not enough information as the participants would like.

    Interviews will also assess what HCC testing (if any) patients think they should have.

Secondary outcomes

  1. Early HCC

    Time frame: 3 years post randomization

    HCC will be defined by AASLD criteria and staged by Barcelona Clinic Liver Cancer (BCLC) system.

    Tumors >1 cm can be diagnosed if CT/MRI shows characteristic findings (arterial enhancement and delayed washout).

    Biopsy may be needed if imaging is not diagnostic.

    Early HCC will be defined as BCLC stage A tumors that are amenable to curative therapy.

    HCC diagnoses and stage will be ascertained from EMR data and confirmed by site investigators.

  2. One-time Screening

    Time frame: Outcomes will be adjudicated 6 months after randomization.

    Defined as the proportion of patients completing HCC screening within 6 months of randomization.

  3. Repeat Screening

    Time frame: Outcomes will be adjudicated 12 months after randomization.

    Defined as the proportion of patients completing HCC screening every 6 months within 12 months of randomization. Patients will be categorized as completed all screening (2 screening in 12 months), some screening (1 screening in 12 months), or no screening (0 screening in 12 months).

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • Michael E. DeBakey VA Medical Center
  • Parkland Health and Hospital System

Registry information

Official study title

Comparative Effectiveness Trial of Care Delivery Strategies for HCC Screening Process Completion

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Oct 21, 2015
Registry last updated
Sep 28, 2022

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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