NCT02312817

Brief Summary

Hepatocellular carcinoma (HCC) is the 9th leading cause of cancer-related death in the US and one of the leading causes of death in patients with cirrhosis. Fewer than 1 in 5 high-risk patients undergo HCC screening, with lower rates in non-Caucasian and low socioeconomic status patients receiving care through safety-net health systems. Screening and follow-up failures lead to more advanced cancers, when curative therapies are not available and survival is significantly worse. Over 60% of HCC are diagnosed at advanced stages, due to poor recognition of high-risk patients, underuse of screening among these patients, and poor follow-up of abnormal screening tests. To address these barriers, the investigators propose to conduct a comparative effectiveness research randomized controlled trial of three screening strategies among a socioeconomically disadvantaged and racially diverse cohort of cirrhotic patients at high risk for developing HCC. Overall, 1800 patients attending Parkland, the Dallas safety-net health system, will be randomized to:

  • Group 1: Usual care, with visit-based HCC screening per discretion of individual providers
  • Group 2: Mailed HCC screening invitation outreach to eligible patients (low resource intensity)
  • Group 3: Mailed HCC screening invitation outreach to eligible patients combined with centralized patient navigation to promote screening completion and follow-up (high resource intensity) Through three specific aims, this effectiveness research randomized controlled trial will:
  • Aim 1: Engage stakeholders in design and implementation of HCC screening outreach interventions.
  • Aim 2: Compare the clinical effectiveness and patient acceptability of the intervention strategies to increase completion of one-time and repeat HCC screening.
  • Aim 3: Evaluate whether intervention effects are moderated by patient sex, race, ethnicity, English proficiency, and connectedness to primary care. The screening intervention strategies combine EMR-enabled case identification, system-level screening outreach, and patient navigation to improve identification of previously unrecognized cirrhotic patients, promote HCC screening completion, and facilitate follow-up of abnormal screening tests. This study will engage stakeholders throughout the research process, evaluate the effectiveness and acceptability of HCC screening strategies, and determine which patient subgroups benefit the most.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 18, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

July 15, 2025

Status Verified

November 1, 2017

Enrollment Period

2.7 years

First QC Date

June 18, 2014

Last Update Submit

July 9, 2025

Conditions

Carcinoma, HepatocellularLiver Neoplasms

Keywords

Carcinoma, HepatocellularLiver NeoplasmsLiver DiseaseEarly Detection of CancerComparative Effectiveness Research

Outcome Measures

Primary Outcomes (2)

  • One-time Screening

    Defined as the proportion of patients completing HCC screening within 6 months of randomization.

    Outcomes will be adjudicated 6 months after randomization.

  • Repeat Screening (Every 6 Months)

    Defined as the proportion of patients completing HCC screening every 6 months within 18 months of randomization.

    Outcomes will be adjudicated 18 months after randomization.

Secondary Outcomes (7)

  • Repeat Screening (Every 7 Months)

    Outcomes will be adjudicated 21 months after randomization.

  • HCC and Early HCC

    Outcomes will be adjudicated 18 and 21 months after randomization.

  • Any HCC Screening

    Outcomes will be adjudicated 18 and 21 months after randomization.

  • Predictors of HCC Screening Completion

    Outcomes will be adjudicated 18 and 21 months after randomization.

  • Intervention Cost

    Outcomes will be adjudicated 18 and 21 months after randomization.

  • +2 more secondary outcomes

Study Arms (3)

Group 1

NO INTERVENTION

Individuals randomized to Group 1 will receive usual medical care and will not be directly contacted at any point of the trial. Study data and outcomes will be abstracted from the EMR.

Group 2

EXPERIMENTAL

Individuals randomized to Group 2 will receive mailed outreach invitation.

Other: Mailed Outreach Invitation

Group 3

EXPERIMENTAL

Individuals randomized to Group 3 will receive mailed outreach invitation and patient navigation.

Other: Mailed Outreach Invitation and Patient Navigation

Interventions

Mailed Outreach InvitationOTHER

Individuals randomized to Group 2 will receive: 1. Mailed outreach invitation to complete HCC screening ultrasound and alpha-fetoprotein (AFP) blood test. 2. "Live" phone calls 2 to 4 weeks after the mailed invitation to facilitate HCC screening completion. Up to three attempts will be made. All communications will use standard English or Spanish scripts. 3. Centralized process to promote guideline-appropriate follow up testing with CT or MRI or referral to GI Clinic.

Group 2
Mailed Outreach Invitation and Patient NavigationOTHER

Individuals randomized to Group 3 will receive: 1. Mailed outreach invitation to complete HCC screening ultrasound and alpha-fetoprotein (AFP) blood test. 2. "Live" phone calls 2 to 4 weeks after the mailed invitation to facilitate HCC screening completion "and address patients' self-reported barriers to HCC screening (e.g., it does not apply to me). Up to three attempts will be made. All communications will use standard English or Spanish scripts. 3. Centralized navigation to promote screening completion (i.e., appointment reminder phone calls from patient navigator) and guideline-appropriate follow up testing with CT or MRI or referral to GI Clinic.

Group 3

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parkland patients ≥ 21 years of age
  • Diagnosis of cirrhosis or meets criteria for suspected cirrhosis
  • ≥ 1 outpatient visit during 12 months prior to randomization
  • Contact information on file
  • English or Spanish speaking

You may not qualify if:

  • HCC or suspicious mass on imaging
  • Any malignancy except malignant neoplasm of skin
  • Metastatic solid tumor
  • Palliative care referral
  • Liver transplant
  • Child Pugh C

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parkland Health & Hospital System

Dallas, Texas, 75235, United States

Location

Related Publications (2)

  • Singal AG, Tiro JA, Murphy CC, Marrero JA, McCallister K, Fullington H, Mejias C, Waljee AK, Pechero Bishop W, Santini NO, Halm EA. Mailed Outreach Invitations Significantly Improve HCC Surveillance Rates in Patients With Cirrhosis: A Randomized Clinical Trial. Hepatology. 2019 Jan;69(1):121-130. doi: 10.1002/hep.30129. Epub 2018 Dec 14.

    PMID: 30070379DERIVED

  • Singal AG, Tiro JA, Marrero JA, McCallister K, Mejias C, Adamson B, Bishop WP, Santini NO, Halm EA. Mailed Outreach Program Increases Ultrasound Screening of Patients With Cirrhosis for Hepatocellular Carcinoma. Gastroenterology. 2017 Feb;152(3):608-615.e4. doi: 10.1053/j.gastro.2016.10.042. Epub 2016 Nov 5.

    PMID: 27825963DERIVED

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver NeoplasmsLiver Diseases

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System Diseases

Intervention Hierarchy (Ancestors)

Patient-Centered CarePrimary Health CareComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Amit Singal, MD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 18, 2014

First Posted

December 9, 2014

Study Start

December 1, 2014

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

July 15, 2025

Record last verified: 2017-11

Locations

US(1)