Quality of Life in Patients With Hepatocellular Carcinoma

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02420678
• Other study ID #: AMC 2015-0229
• Status: Recruiting
• Phase: N/A
• First received: March 26, 2015
• Last updated: April 25, 2017
• Start date: April 2015
• Est. completion date: December 2018

Study information

• Verified date: April 2017
• Source: Asan Medical Center
• Contact: Ju Hyun Shim, MD, PhD
• Phone: +82-2-3010-3190
• Email: s5854[@]medimail.co.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical validity of FACT-Hep, EORTC QLQ-HCC18 and NFHSI-18	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.	Baseline
Primary	Reliability of FACT-Hep, EORTC QLQ-HCC18 and NFHSI-18	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.	Baseline and at least 6 hours later
Secondary	Recurrence rates		upto 3 years
Secondary	Death rates		upto 3 years