Texas Hepatocellular Carcinoma Consortium (THCCC) Project 5
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|ClinicalTrials.gov Identifier: NCT02582918|
Recruitment Status : Active, not recruiting
First Posted : October 21, 2015
Last Update Posted : May 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Hepatocellular Liver Neoplasms||Behavioral: Outreach with patient education and patient navigation services||Not Applicable|
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)|
|Actual Enrollment :||2871 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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 2022|
|Estimated Study Completion Date :||August 2022|
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
- 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.
- 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).
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
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Amit G Singal, MD||University of Texas Southwestern Medical Center|