Clinical trial NCT02420678: Quality of Life in Patients With Hepatocellular Carcinoma
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2015-04-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Admitted hepatocellular carcinoma (HCC) patients will be screened to determine study eligibility.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Diagnosis of HCC
* Ability to speak, read, and write Korean
* Patient is able and willing to give informed consent

Exclusion Criteria:

* Evidence of cognitive impairment or psychiatric disturbance
* Other concurrent malignancy
* Patients involved in other clinical studies

Primary outcomes:
measure: Clinical validity of FACT-Hep, EORTC QLQ-HCC18 and NFHSI-18
timeFrame: Baseline
measure: Reliability of FACT-Hep, EORTC QLQ-HCC18 and NFHSI-18
timeFrame: Baseline and at least 6 hours later
Secondary outcomes:
measure: Recurrence rates
timeFrame: upto 3 years
measure: Death rates
timeFrame: upto 3 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine
name: Ju Hyun Shim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: