Initial Validation of the FACT-Hep Questionnaire for Assessing Health-Related Quality of Life in Advanced Intrahepatic Cholangiocarcinoma
Teerachat Saeheng
Center of Excellence in Pharmacology and Molecular Biology of Malaria and Cholangiocarcinoma, Chulabhorn International College, 99 Moo 18 Phaholyothin Road, Thammasat University (Rangsit Campus), Klongneung, Klongluang District, Pathumthani Province 12121, Thailand.
Kesara Na-Bangchang
*
Center of Excellence in Pharmacology and Molecular Biology of Malaria and Cholangiocarcinoma, Chulabhorn International College, 99 Moo 18 Phaholyothin Road, Thammasat University (Rangsit Campus), Klongneung, Klongluang District, Pathumthani Province 12121, Thailand and Drug Discovery and Development Center, Office of Advanced Science and Technology, 99 Moo 18, Phaholyothin Road, Thammasat University (Rangsit Campus), Klongneung, Klongluang District, Pathumthani Province 12121, Thailand.
*Author to whom correspondence should be addressed.
Abstract
Health-related quality of life (HRQOL) assessment is an important component of clinical evaluation in patients with advanced intrahepatic cholangiocarcinoma (iCCA), particularly when disease burden and treatment-related effects affect physical, emotional, social, and functional well-being. This study examined the applicability of the Functional Assessment of Cancer Therapy-Hepatobiliary questionnaire for assessing HRQOL in patients with advanced-stage iCCA. The analysis was conducted within an open-label, randomised, controlled phase IIA clinical trial evaluating Atractylodes lancea capsules. Thirty-nine eligible patients completed the baseline assessment and were included in reliability and validity analyses. The Thai version of FACT-Hep was assessed at baseline and during follow-up using internal consistency, test-retest reliability, construct validity, discriminant validity, effect size, minimally important clinical difference estimates, and associations with clinical response indicators. The questionnaire demonstrated acceptable internal consistency at baseline and early follow-up, with Cronbach's alpha values exceeding the commonly accepted threshold during the initial assessment period. Test-retest reliability showed moderate-to-good performance across several domains, although estimates were weaker for some components and later time points. Construct validity analysis indicated that most items met the predefined correlation threshold, whereas a small number showed weaker convergence. The Hepatobiliary Cancer Subscale distinguished patients by baseline ECOG performance status, and selected functional and emotional well-being scores differed by disease progression status during follow-up. Interpretation of longitudinal findings was limited by high attrition and the small number of patients available at later assessments. Overall, FACT-Hep may be useful for preliminary HRQOL assessment in advanced iCCA, although further validation in larger cohorts is required.
Keywords: FACT-Hep, intrahepatic cholangiocarcinoma, cholangiocarcinoma, hepatobiliary cancer, health-related quality of life, patient-reported outcomes, validation study, reliability, construct validity, ECOG performance status, Atractylodes lancea, advanced cancer