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Quality of Life in Patients With Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT02420678
Recruitment Status : Unknown
Verified April 2017 by Ju Hyun Shim, Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : April 20, 2015
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Ju Hyun Shim, Asan Medical Center

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.


Condition or disease
Hepatocellular Carcinoma

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : April 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018



Primary Outcome Measures :
  1. Clinical validity of FACT-Hep, EORTC QLQ-HCC18 and NFHSI-18 [ Time Frame: Baseline ]
    The FACT-Hep questionnaire consists of 18-item Hepatobiliary Subscales and 27-item FACT-G, which contains physical (7 items), social (7 items), emotional (6 items), and functional scales (7 items). Hepatobiliary Subscale is scored 0-72, FACT-G is scored 0-108, and FACT-Hep is scored 0-180. EORTC QLQ-HCC 18 is an 18-item questionnaire designed to be used along with the 30-item EORTC QLQ-C30. EORTC QLQ-HCC 18 questionnaire includes 8 symptom scales such as fatigue, jaundice, nutrition, pain, fever, abdominal swelling, sexual interest, and body image. Each item is scored 0-100 according to the EORTC guidelines. NFHSI-18 consists of 18-item scales, and each item is scored 0-4, yielding a total between 0 and 72. The investigators will test the validity by using the correlation and comparison of all of the questionnaire scores at baseline.

  2. Reliability of FACT-Hep, EORTC QLQ-HCC18 and NFHSI-18 [ Time Frame: Baseline and at least 6 hours later ]
    Patients will complete the questionnaires at baseline and then will respond to the follow-up surveys at least 6 hours later the first assessment. The investigators will examine reliability by assessing test-retest reliability of each survey after measuring the scores of questionnaires at two assessment points.


Secondary Outcome Measures :
  1. Recurrence rates [ Time Frame: upto 3 years ]
  2. Death rates [ Time Frame: upto 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Admitted hepatocellular carcinoma (HCC) patients will be screened to determine study 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02420678


Contacts
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Contact: Ju Hyun Shim, MD, PhD +82-2-3010-3190 s5854@medimail.co.kr

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Ju Hyun Shim, MD, PhD    +82-2-3010-3190    s5854@medimail.co.kr   
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Ju Hyun Shim, MD, PhD Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine

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Responsible Party: Ju Hyun Shim, Assistant Profesor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02420678     History of Changes
Other Study ID Numbers: AMC 2015-0229
First Posted: April 20, 2015    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Liver Diseases