Background: The FACT-Hep questionnaire has been used to evaluate the health-related quality of life (HRQOL) in various types of hepatobiliary cancer. Nevertheless, the application in intrahepatic cholangiocarcinoma (iCCA) has been limited. The study aimed to validate the applicability of FACT-Hep as a reliable tool for evaluating HRQOL in patients with advanced-stage iCCA.
Methods: Atractylodes lancea capsules were tested for efficacy and safety in a randomized, controlled phase IIA. Internal consistency, intraclass correlation, test-retest reliability, discriminant and convergent validity, and FACT-Hep score-clinical response connection were assessed.
Results: Thirty-nine patients qualified for the research. Cronbach's alpha coefficients > 0.7 showed internal consistency for all subscale items from baseline (day 1) to 90 days. For ICC, convergent, and discriminant validity, all items except the HepCS subscale were reliable. Patients with ECOG scores of 0-1 or 2 had significantly different HepCS subscale values-calculated effect size for subscale score change over time. FACT-G and FWB differed significantly in low-dose group 1. At 3-month, 1-month, and 2-month follow-ups, Group 2 (high dose) patients had significant differences in FACT-Hep, TOI, and HepCS. The effect size was the same in Group 3 (untreated). Group 1 and 2 non-progressive patients exhibited lower FWB and EWB scores than progressive patients. The treated survivors had lower FACT-Hep, TOI, HepCS, FWB, and EWB scores than the non-treated survivors, which was linked to AL treatment side effects.
Conclusion: The FACT-Hep detects changes and is a reliable and valid tool for assessing HRQOL in patients with advanced-stage iCCA.
Copyright: © 2025 Saeheng et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.