Hepatocellular Carcinoma Clinical Trial
Official title:
Validation of Questionnaire Module for Quality of Life and Analysis of Its Association With Clinical Outcomes; a Cohort Study in Patients With Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is the sixth most common cancer and the second leading cause
of cancer-related mortality worldwide. Despite the recent advances in the treatment of HCC,
the prognosis of HCC is still poor even after curative treatment.
Performance status has shown to be associated with long-term survival and prognosis in
patients with HCC, and it is one of the important factors in the Barcelona Clinic Liver
Cancer (BCLC) staging system. Recently, the researches on health-related quality of life
(HRQL) of cancer patients have been progressed. The most widely used surveys to assess HRQL
of cancer patients are Functional Assessment of Cancer Therapy-Generic (FACT-G) and European
Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire
(QLQ)-C30. Since those two are mainly about cancers in general, HCC specific surveys were
developed.
The FACT-Hep questionnaire has 45-items specifically focusing on patients with hepatobiliary
cancers. EORTC QLQ-hepatocellular carcinoma 18 (HCC 18) is an 18-item questionnaire designed
to be used along with the EORTC QLQ-C30 for patients with HCC. An 18-item National
Comprehensive Cancer Network (NCCN)-FACT Hepatobiliary-Pancreatic Symptom Index (NFHSI-18)
is a specific questionnaire for advanced hepatobiliary and pancreatic cancers. However,
there is no consensus whether it would be appropriate to adopt HRQL as a prognostic variable
in HCC staging system. Moreover, there is limited information available about the impact of
patients' HRQL on long-term outcome in patients with HCC.
Thus, in this study, the researchers will investigate whether HRQL can be an important
factor in HCC staging system by testing the reliability and clinical validity of FACT-Hep,
EORTC QLQ-HCC18, and NFHSI-18. Second, the investigators will evaluate the relation of HRQL
with treatment efficacy, recurrence and survival outcome. Lastly, the investigators will
suggest the suitable questionnaire module for patients with HCC.
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