An observational study in Carcinoma, Hepatocellular, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2024-12-30.
Sponsored by University of Texas Southwestern Medical Center · Observational
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 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.
Leveraging a multi-center randomized controlled trial assessing screening benefits in a socioeconomically and racially diverse population of 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.
3,249 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.
This study's enrollment of 2,871 is above the median of 200 across 769 observational studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →University of Texas Southwestern Medical Center is the lead sponsor of 1,009 studies on the registry; 201 are open to participants now.
Of its 138 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
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All patients from the parent randomized controlled trial will be included in this study.
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Inclusion and exclusion criteria of the parent randomized controlled trial are as follows:
Inclusion Criteria:
Exclusion Criteria:
This study will collect prospective longitudinal data to characterize rates and identify correlates of a) physical harms due to follow-up tests, b) financial harms, and c) inappropriate screening using electronic medical record data and manual chart review. The study will also use surveys and semi-structured interviews to characterize rates and identify correlates of screening-related psychological harms, e.g. cancer specific worry, situational anxiety, mood disturbances, and decisional regret. Lastly, investigators will create and disseminate a balance sheet of benefits and harms to inform patients, providers, healthcare organizations, payers, and policymakers about the role of hepatocellular carcinoma screening in patients with cirrhosis.
Other: Prospective Longitudinal Data · Other: Surveys and Semi-structured Interviews
We will prospectively follow the cohort using electronic medical record to document the hepatocellular carcinoma screening process and characterize physical and financial harms related to positive or indeterminate screening results and burden of inappropriate screening. Patients are anticipated to undergo hepatocellular carcinoma screening every 6-12 months, so each patient will have \~4-8 screening encounters over the study duration. We will use manual chart review to determine intent of ultrasound exams (screening vs. diagnostic) and test results. Receipt of follow-up tests after positive or indeterminate screening results will be identified through electronic medical record extraction using Current Procedural Terminology (CPT) codes for CT, MRI, and biopsy.
We will use surveys and semi-structured interviews to characterize psychological harms after positive or indeterminate screening tests. Patient surveys will include patient-reported scales to measure psychosocial factors at three times points: baseline, 1 month after screening result, and 4 months after screening result. Semi-structured interviews will be conducted via telephone to explore patient attitudes toward risk perception, test follow-up, competing demands, and "downstream harms", particularly financial issues (e.g., out-of-pocket costs, access to insurance, and juggling hepatocellular carcinoma screening process completion with competing demands-work and family).
Physical Harms
Physical harms (contrast injury, radiation exposure, and biopsy complications) can result from screening or follow-up testing and extends beyond medical complications to include discomfort. A binary outcome (harm vs. no harm) will be defined for each person and each type of physical harm (contrast injury, radiation exposure, biopsy, and any physical harm). We will report the point estimate and 95% confidence interval for the proportion of patients with each type of harm in each arm, stratified by health system. Using an intention-to-treat principle, we will use Chi squared test to compare the proportion of patients with physical harms between the screening and usual care arms, with a secondary analysis stratified by health system. We will also perform a sensitivity analysis based on test intent, in which we will only include tests (and corresponding harms) performed as a direct result of hepatocellular carcinoma screening.
Time frame: 4 Years
Financial Harms
Financial harms may include anticipated or real costs of hepatocellular carcinoma screening and diagnostic evaluation including, indirect costs such as missed work, and opportunity costs such as distraction from other health-related activities. Financial harms will be summarized for each arm using descriptive analyses as average and range of costs per person. Degree of financial harms will be compared between the hepatocellular carcinoma screening and usual care arms using Student T test, with a secondary analysis stratified by health system. In a secondary analysis, a mixed-effect model approach will be employed to identify patient-, provider- and system-level factors associated with financial harm.
Time frame: 4 Years
Overdiagnosis
Defined as hepatocellular carcinoma diagnoses that are unlikely to have an effect on mortality, specifically among patients with: 1) significant comorbid conditions or 2) severe liver dysfunction, i.e. Child Pugh C cirrhosis, who are not candidates for liver transplantation, at hepatocellular carcinoma diagnosis. For the primary analysis, Chi squared test will be used to compare the proportion of patients with overdiagnosis between the screening arm and usual care arm, stratified by health system.
Time frame: 4 Years
Psychosocial Harms
Patients will be divided into 4 categories: true positives, false positives, true negatives, and no screening. True positives will be defined as those who develop hepatocellular carcinoma within 6 months of the screening test; false positives as those who remain without hepatocellular carcinoma diagnosis during 6 months of follow-up; and true negatives as those with normal screening tests and without hepatocellular carcinoma diagnosis during 6 months of follow-up. Psychosocial harms (cancer-specific worry, situational anxiety, mood disturbances, and decisional regret) will be defined by change in survey scores from baseline and will be calculated at 1 month and 6 months for each patient.
Time frame: 4 Years
Patient-, Provider-, and System-level Factors Associated with Physical Harms
As a secondary analysis, we will construct mixed-effect logistic regression models to identify patient-, provider-, and system-level factors associated with physical harms (contrast injury, radiation exposure, biopsy, and any physical harm). Models will include random effects for providers and health systems to account for potential correlation at different levels. Final models will include covariates identified by stepwise variable selection procedure and those considered clinically important a priori (BMI, race, liver dysfunction, and gastroenterology care). Statistical significance will be declared for p\<0.05.
Time frame: 4 Years
Patient-, Provider-, and System-level Factors Associated with Psychosocial Harms
We will construct a mixed regression model with the outcome being decisional regret and covariates including patient-, provider- and system-level factors. Decisional regret score, ranging from 0 to 100, will be analyzed as a continuous outcome. The mixed model will include random effects for providers and systems to account for correlation at different levels. The model will include covariates identified through stepwise variable selection and those considered clinically important a priori (age, gender, race and ethnicity, liver dysfunction).
Time frame: 4 Years
Physical Harms
Physical harms (contrast injury, radiation exposure, and biopsy complications) can result from screening or follow-up testing and extends beyond medical complications to include discomfort.
Time frame: 12 Months
Plan to share: No
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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