Objective: To evaluate the effectiveness of the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire in measuring the quality of life in patients with primary hepatic carcinoma (PHC) in China.
Methods: FACT-Hep questionnaire was translated into Chinese and revised properly. From September 2005 to April 2006, one hundred and eighty patients with primary liver carcinoma were admitted and measured by using the Chinese version of FACT-Hep questionnaire, and the reliabilities, validities and responsibilities of the questionnaire were assessed.
Results: Correlation coefficient was higher between items and dimension of their corresponding domain (0.593 3±0.165 2) than that between the items and other domains (0.274 9±0.192 2). Six principal constituents were extracted by factor analysis and represented all domains of the questionnaire. The combinations of components were consistent with what was expected. The correlation coefficient of criterion-related validity was 0.828. The test-retest reliability correlation coefficients of physical, social/family, emotion, function, symptom and total questionnaire were 0.731, 0.334, 0.953, 0.786, 0.785 and 0.801 respectively, and the values of Cronbach's alpha were 0.739 7, 0.419 3, 0.791 4, 0.825 0, 0.839 9 and 0.916 1, respectively. There were statistical differences in scores of FACT-Hep questionnaire in different PHC stages or in different Child-Pugh classes (P<0.05).
Conclusion: The FACT-Hep questionnaire can measure the quality of life in patients with PHC with good reliability, validity and responsiveness; it can be used in assessing the disease-specific health-related quality of life of patients with hepatobiliary cancers.

Key words: primary hepatic carcinoma, quality of life, clinical trial, China