MedTrace Logo

Texas Hepatocellular Carcinoma Consortium (THCCC) Project 5

NCT02582918 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2871

Last updated 2022-09-28

No results posted yet for this study

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).

Conditions

  • Carcinoma, Hepatocellular
  • Liver Neoplasms

Interventions

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.

Sponsors & Collaborators

  • Parkland Health and Hospital System

    collaborator OTHER

  • Michael E. DeBakey VA Medical Center

    collaborator FED

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Amit G Singal, MD · University of Texas Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-26
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02582918 on ClinicalTrials.gov