Clinical trial NCT03756051: Harms of Hepatocellular Carcinoma Surveillance
Official title: Harms of Hepatocellular Carcinoma Surveillance in Patients With Cirrhosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Hepatocellular
Keywords: Physical Harms
Financial Harms
Overdiagnosis
Psychosocial Harms
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Parkland Health and Hospital System
name: Baylor College of Medicine
name: Michael E. DeBakey VA Medical Center
name: Kaiser Permanente
First posted: 2018-11-28
Enrollment: 2871
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients from the parent randomized controlled trial will be included in this study.

Brief summary: 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.

Detailed description: 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.

Eligibility 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)

Primary outcomes:
measure: Physical Harms
timeFrame: 4 Years
measure: Financial Harms
timeFrame: 4 Years
measure: Overdiagnosis
timeFrame: 4 Years
measure: Psychosocial Harms
timeFrame: 4 Years
Secondary outcomes:
measure: Patient-, Provider-, and System-level Factors Associated with Physical Harms
timeFrame: 4 Years
measure: Patient-, Provider-, and System-level Factors Associated with Psychosocial Harms
timeFrame: 4 Years
measure: Physical Harms
timeFrame: 12 Months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Amit Singal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Singal 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.