- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02582918
Texas Hepatocellular Carcinoma Consortium (THCCC) Project 5
Comparative Effectiveness Trial of Care Delivery Strategies for HCC Screening Process Completion
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75390
- University of Texas Southwestern Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Group 1: Usual Care
Usual care with opportunistic visit-based HCC surveillance.
|
|
Experimental: Group 2: Patient Education and Patient Navigation Services
Mailed HCC surveillance outreach with patient education and patient navigation services.
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Completion of HCC surveillance process
Time Frame: 3 years post randomization
|
Ascertained through EMR. HCC surveillance process completion will be defined as:
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. |
3 years post randomization
|
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:
Interviews will also assess what HCC testing (if any) patients think they should have. |
3 years post randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Outcomes will be adjudicated 6 months after randomization.
|
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. |
3 years post randomization
|
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).
|
Outcomes will be adjudicated 12 months after randomization.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Amit G Singal, MD, University of Texas Southwestern Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 062015-054
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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