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Texas Hepatocellular Carcinoma Consortium (THCCC) Project 5

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02582918
Recruitment Status : Active, not recruiting
First Posted : October 21, 2015
Last Update Posted : May 19, 2020
Sponsor:
Collaborators:
Parkland Health & Hospital System
VA Medical Center, Houston
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE October 13, 2015
First Posted Date  ICMJE October 21, 2015
Last Update Posted Date May 19, 2020
Actual Study Start Date  ICMJE March 26, 2018
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2015)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 20, 2015)
  • 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.
  • 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. We will interview 30 completers and 30 non-completers from each group at each site (540 total). We will stratify sampling to include both patients with documented cirrhosis and unrecognized cirrhosis. Likert scale items will assess reactions:
    • You were confused why you were referred for HCC screening
    • You were not given enough information to make a decision
    • You don't want to know if you have HCC
    • Information about HCC was new and items assessing if invitations included more, right amount, or not enough information as you would like.
    Interviews will also assess what HCC testing (if any) patients think they should have.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2019)
  • 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.
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2015)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Texas Hepatocellular Carcinoma Consortium (THCCC) Project 5
Official Title  ICMJE Comparative Effectiveness Trial of Care Delivery Strategies for HCC Screening Process Completion
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Screening
Condition  ICMJE
  • Carcinoma, Hepatocellular
  • Liver Neoplasms
Intervention  ICMJE Behavioral: 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Outreach with patient education and patient navigation services
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 2, 2019)
2871
Original Estimated Enrollment  ICMJE
 (submitted: October 20, 2015)
3000
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02582918
Other Study ID Numbers  ICMJE 062015-054
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE
  • Parkland Health & Hospital System
  • VA Medical Center, Houston
Investigators  ICMJE
Principal Investigator: Amit G Singal, MD University of Texas Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP