Health related quality of life in patients with Cirrhosis

Study ID
STU 122010-140

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

  • Parkland Health & Hospital System

Contact
Olutola Yerokun
817-308-7648
olutola.yerokun@utsouthwestern.edu

Principal Investigator
Amit Singal

Summary

Study Design:
This study will involve giving self-administered surveys to cirrhotic patients with or without HCC followed in the Parkland outpatient clinics (HCC clinic, oncology clinics, or Hepatology clinic). electronic medical records of these patients will be reviewed to document any necessary demographic and clinical information.

Protocol:
a convenience sample of patients with a known diagnosis of HCC, who are currently being followed in the Parkland Hepatology or HCC clinics, will be enrolled in our study. The online medical records of these patients will be screened prior to their appointment to confirm eligibility, according to inclusion and exclusion criteria as described above. Patients from this cohort will be enrolled in clinic and asked to complete self-administered surveys (eoRT QLQ-HCC18 and QLQ-C30) while waiting for their appointment. Patients will be asked to complete the survey every 3 months, prior to their clinic appointment.

We will review the electronic medical records of those patients who complete the survey to document their demographic information (age, gender, race, insurance status, primary language), the presence of any significant comorbid conditions (diabetes, CoPD, DM, renal failure), cause of underlying liver disease, degree of hepatic decompensation (ascites, encephalopathy, and varices), frequency of physician use, number of hospitalizations since last clinic visit, lab data (CBC, comprehensive panel, coagulation parameters, and aFP), Child Pugh score and MeLD score, tumor stage, and any treatments received for their HCC. Two people (a.S and e.o.) will obtain all necessary information (from the survey and medical records), and enter it into a customized database.

The primary endpoint of this study is to determine the effect of tumor stage on HRQoL in patients with HCC. HRQoL will be measured using previously validated surveys for liver disease and HCC (eoRT QLQ-HCC18 and QLQ-C30). other independent factors of interest (in addition to tumor stage) include age, gender, race, insurance status, level of social/provider support, frequency of physician use, number of hospitalizations since last clinic visit, underlying etiology of liver disease, degree of hepatic decompensation, and performance status.

For aim 2, the primary endpoint will be assessing level of knowledge about HCC screening and cirrhosis care. The survey will be a previously validated survey from the university of Michigan. independent factors of interest will be age, gender, race, insurance status, social support, underlying etiology, number of primary care and hepatology clinic visits, degree of hepatic decompensation, and quality of life.

Participant Eligibility

The study cohort will consist of all adult cirrhotic patients with or without HCC. Diagnosis of HCC in this study is based on AASLD criteria and includes: (1) histology or (2) imaging demonstrating diagnostic characteristics (arterial enhancement and delayed washout on cross-sectional imaging). Patients will be identified through appointments in the Parkland Hepatology clinics, medical oncology clinics, or the HCC clinic.