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Texas Hepatocellular Carcinoma Consortium (THCCC) Project 5

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ClinicalTrials.gov Identifier: NCT02582918
Recruitment Status : Enrolling by invitation
First Posted : October 21, 2015
Last Update Posted : April 27, 2018
Sponsor:
Collaborators:
Parkland Health & Hospital System
VA Medical Center, Houston
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

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).

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Liver Neoplasms Behavioral: Outreach with patient education and patient navigation services Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Screening
Official Title: Comparative Effectiveness Trial of Care Delivery Strategies for HCC Screening Process Completion
Actual Study Start Date : March 26, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

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.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.




Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02582918


Locations
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Parkland Health & Hospital System
VA Medical Center, Houston
Investigators
Principal Investigator: Amit G Singal, MD University of Texas Southwestern Medical Center

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02582918     History of Changes
Other Study ID Numbers: 062015-054
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Texas Southwestern Medical Center:
Randomized Controlled Trial
Mass Screening

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases