Texas Hepatocellular Carcinoma Consortium (THCCC) Project 5

NCT ID: NCT02582918

Last Updated: 2022-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2871 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-26
• Study Completion Date: 2022-06-30

Brief 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).

Detailed 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.

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

Group 1: Usual Care

Usual care with opportunistic visit-based HCC surveillance.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group 2: Patient Education and Patient Navigation Services

Mailed HCC surveillance outreach with patient education and patient navigation services.

Group Type: EXPERIMENTAL

Outreach with patient education and patient navigation services

Intervention Type: 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.

Interventions

Outreach with patient education and patient navigation services

• 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parkland Health and Hospital System

OTHER

Sponsor Role: collaborator

Michael E. DeBakey VA Medical Center

FED

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Amit Singal

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amit G Singal, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

References

Singal AG, Daher D, Narasimman M, Yekkaluri S, Liu Y, Cerda V, Banala C, Khan A, Lee M, Seif El Dahan K, Murphy CC, Kramer JR, Hernaez R. Benefits and harms of hepatocellular carcinoma screening outreach in patients with cirrhosis: a multicenter randomized clinical trial. J Natl Cancer Inst. 2025 Feb 1;117(2):262-269. doi: 10.1093/jnci/djae228.

Reference Type: DERIVED

PMID: 39288308 (View on PubMed)

Singal AG, Narasimman M, Daher D, Yekkaluri S, Liu Y, Lee M, Cerda V, Khan A, Seif El Dahan K, Kramer J, Gopal P, Murphy C, Hernaez R. Effectiveness of mailed outreach and patient navigation to promote HCC screening process completion: a multicentre pragmatic randomised clinical trial. Gut. 2024 Nov 11;73(12):2037-2044. doi: 10.1136/gutjnl-2024-332508.

Reference Type: DERIVED

PMID: 38839269 (View on PubMed)

Singal AG, Reddy S, Radadiya Aka Patel H, Villarreal D, Khan A, Liu Y, Cerda V, Rich NE, Murphy CC, Tiro JA, Kramer JR, Hernaez R. Multicenter Randomized Clinical Trial of a Mailed Outreach Strategy for Hepatocellular Carcinoma Surveillance. Clin Gastroenterol Hepatol. 2022 Dec;20(12):2818-2825.e1. doi: 10.1016/j.cgh.2021.12.014. Epub 2021 Dec 10.

Reference Type: DERIVED

PMID: 34902568 (View on PubMed)

Other Identifiers

062015-054

Identifier Type: -

Identifier Source: org_study_id