Quality of Life in Patients With Hepatocellular Carcinoma
NCT ID: NCT02420678
Last Updated: 2017-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2015-04-30
2018-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of HCC
* Ability to speak, read, and write Korean
* Patient is able and willing to give informed consent
Exclusion Criteria
* Other concurrent malignancy
* Patients involved in other clinical studies
18 Years
ALL
No
Sponsors
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Asan Medical Center
OTHER
Responsible Party
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Ju Hyun Shim
Assistant Profesor
Principal Investigators
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Ju Hyun Shim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AMC 2015-0229
Identifier Type: -
Identifier Source: org_study_id
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