Texas Hepatocellular Carcinoma Consortium (THCCC) Project 5
Comparative Effectiveness Trial of Care Delivery Strategies for HCC Screening Process Completion
1 other identifier
interventional
2,871
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2015
CompletedFirst Posted
Study publicly available on registry
October 21, 2015
CompletedStudy Start
First participant enrolled
March 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedSeptember 28, 2022
September 1, 2022
4.3 years
October 13, 2015
September 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Completion of HCC surveillance process
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.
3 years post randomization
Patient satisfaction and acceptability
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.
3 years post randomization
Secondary Outcomes (3)
Early HCC
3 years post randomization
One-time Screening
Outcomes will be adjudicated 6 months after randomization.
Repeat Screening
Outcomes will be adjudicated 12 months after randomization.
Study Arms (2)
Group 1: Usual Care
NO INTERVENTIONUsual care with opportunistic visit-based HCC surveillance.
Group 2: Patient Education and Patient Navigation Services
EXPERIMENTALMailed HCC surveillance outreach with patient education and patient navigation services.
Interventions
* 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.
Eligibility Criteria
You may qualify if:
- Adult patients (\>21 years old)
- Documented cirrhosis
- Unrecognized cirrhosis
- An outpatient visit in year prior to randomization
- English or Spanish speaking
You may not qualify if:
- History of HCC
- History of liver transplantation
- Child Pugh C cirrhosis
- Significant comorbid conditions with life expectancy \< 1 year, (e.g., extrahepatic malignancy)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Related Publications (3)
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.
PMID: 39288308DERIVEDSingal 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.
PMID: 38839269DERIVEDSingal 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.
PMID: 34902568DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amit G Singal, MD
University of Texas Southwestern Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
October 13, 2015
First Posted
October 21, 2015
Study Start
March 26, 2018
Primary Completion
June 30, 2022
Study Completion
June 30, 2022
Last Updated
September 28, 2022
Record last verified: 2022-09