QUALITATIVE PATIENT INTERVIEWS TO SUPPORT THE FACT HEPATOBILIARY SYMPTOM INDEX-8 AMONG PATIENTS WITH HEPATOCELLULAR CARCINOMA AND ELEVATED BASELINE ALPHA-FETOPROTEIN

OBJECTIVES: The FACT Hepatobiliary Symptom Index 8 (FHSI-8) is a patient-reported questionnaire that assesses priority symptoms identified by patients with hepatobiliary cancers (HCC). In this study, qualitative interviews were conducted to assess the content validity of the FHSI-8 among HCC patients with severe disease, as indicated by elevated alpha-fetoprotein (AFP). METHODS: Utilizing a semi-structured interview guide, mixed concept elicitation and cognitive debriefing interviews were conducted via telephone with 7 adults with HCC and physician-confirmed elevated AFP (> 400 ng/mL). Recruitment was challenging due to the severity and poor prognosis of HCC, therefore multiple recruitment methods (clinical sites, advocacy groups and qualitative research firms) were employed. Field notes and interview transcriptions were used for thematic data analysis. RESULTS: All 7 participants reported pain, fatigue, lack of energy, and weight loss; 6 reported nausea, and 5 reported back pain, jaundice, and appetite loss. In addition, fatigue (n = 6), abdominal pain (n=5), back pain (n=3) and weight loss (n=3) were most frequently reported among the three most important symptoms to treat. Participants indicated that all items were relevant and important to retain, and no participant spontaneously identified any omitted symptoms. Participants easily answered and consistently interpreted all FHSI-8 items as intended, noted that the 7-day recall period was appropriate, and indicated that the response options were distinct. Most participants (n ≥ 5 per item) noted that a 1-point shift constituted a meaningful improvement. CONCLUSIONS: The results of this study are consistent with those of a targeted literature review of 32 publications, and confirm the content validity of the FHSI-8 in HCC patients with elevated AFP. Most importantly, the FHSI-8 assesses the symptoms study participants reported most frequently and identified as important to treat, supporting the use of the FSHI-8 in HCC clinical trials.