Expired Study
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Dallas, Texas 75390


Purpose:

This study leverage a multi-center randomized controlled trial assessing screening-related benefits (i.e. early tumor detection, treatment eligibility, and overall survival) among a racially and socioeconomically diverse population of 3,000 patients with cirrhosis. However, the randomized controlled trial was not budgeted to assess hepatocellular carcinoma screening-related harms. The goal of this study is to quantify physical, financial, and psychosocial harms across three healthcare settings.


Study summary:

Leveraging a multi-center randomized controlled trial assessing screening benefits in a socioeconomically and racially diverse population of 3,000 patients with cirrhosis followed in 3 healthcare settings over a 4-year period, this study aims to: Aim 1: Assess the effect of hepatocellular carcinoma screening on a) physical harms due to follow-up tests, b) financial harms, and c) overdiagnosis in patients with severe liver dysfunction or comorbid illness, through electronic medical record data, manual chart review, and validated survey measures. Aim 2: Assess the effect of hepatocellular carcinoma screening on screening-related psychosocial harms, e.g. cancer-specific worry, situational anxiety, mood disturbances, and decisional regret, through longitudinal validated measures and qualitative interviews. Aim 3: Create and disseminate a balance sheet of benefits and harms to inform patients, providers, healthcare organizations, payers, and policymakers about the value of hepatocellular carcinoma screening in patients with cirrhosis. Over a 4-year period, electronic medical record data will be used to compare screening-related physical and financial harms between patients undergoing and those not undergoing hepatocellular carcinoma screening. Psychosocial harms, as ascertained through longitudinal measurement of validated survey instruments and qualitative interviews, will be compared between patients with positive or indeterminate screening results and those with negative results or without any screening. Mixed-effect regression analysis will be used to determine if screening harms differed by factors at multiple levels including patient (e.g. degree of liver dysfunction), provider (e.g. subspecialty training), and healthcare organization (e.g. access to liver transplantation). This study will seamlessly complement data from the parent randomized controlled trial. By immediately translating these high quality data about hepatocellular carcinoma screening benefits and harms into a balance sheet, the investigators will facilitate patient-provider discussions, inform payer decisions about reimbursement, and guide policy decisions. These data are also crucial to identify modifiable and high-yield intervention targets and strategies to reduce hepatocellular carcinoma screening harms in the future.


Criteria:

Inclusion and exclusion criteria of the parent randomized controlled trial are as follows: Inclusion Criteria: - Adult patients (≥ 21 years old) - Cirrhosis - Outpatient visit in year prior to randomization - English or Spanish speaking Exclusion Criteria: - History of hepatocellular carcinoma - History of liver transplantation - Child Pugh C cirrhosis - Significant comorbid conditions with life expectancy < 1 year, (e.g., extrahepatic malignancy)


NCT ID:

NCT03756051


Primary Contact:

Principal Investigator
Amit Singal, MD
University of Texas Southwestern Medical Center

Amit Singal, MD
Phone: 214-645-6111
Email: Amit.Singal@utsouthwestern.edu


Backup Contact:

Email: Katharine.McCallister@UTSouthwestern.edu
Katharine McCallister
Phone: 214-648-3723


Location Contact:

Dallas, Texas 75390
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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