OBJECTIVES: This study aimed to a) understand the lived experiences of patients with locally advanced or metastatic pancreatic cancer and b) develop a conceptual model to guide future outcomes measurement. Patient-reported outcome (PRO) instruments (EORTC QLQ-C30 & PAN26; FACT-Hep) were assessed for their suitability in this population.

METHODS: Patients with locally advanced or metastatic pancreatic cancer who had received treatment in the past 12 months participated in an interview. A semi-structured interview guide was developed, based on published literature and medical expert interviews (n=6). Interviews were thematically analyzed in ATLAS.ti.v7; quotes were coded to identify concepts. Concepts arising from interviews were grouped into domains to form a conceptual model. Framework analysis was applied to identity PRO conceptual relevance, comprehension, and interpretation.

RESULTS: Twenty-four patients were interviewed (62.5% female, aged 35-84). Before diagnosis, patients experienced pain (n=21) including in the abdomen (n=9) or back (n=6) and jaundice-associated symptoms e.g., yellow skin/eyes (n=8). Treatment included Whipple surgery, chemotherapy and radiation regimens. Surgery was associated with acute pain and gastrointestinal symptoms; chemotherapy/chemo radiation with cyclical side effects including fatigue/tiredness (n=21), appetite loss (n=15), bowel problems (n=15), nausea and vomiting (n=15). Radiation was also associated with skin problems at the radiation site. Patients experienced significant impairment to physical function and daily activities (e.g. tiredness, difficulty walking), sleep, socializing, work, and wellbeing. Patients generally found the QLQ-C30 & PAN26 and FACT-Hep to be understandable and conceptually relevant.

CONCLUSIONS: Pancreatic cancer and its treatment are associated with significant symptoms, side effects, and impact on patient lives. PRO instruments included in clinical trials should assess the effect of therapies on pain, gastrointestinal symptoms and fatigue. The QLQ-C30 & PAN26 and FACT-Hep appeared relevant and suitable to capture symptoms and impacts in clinical trials but FACT-Hep assesses additional distal impacts. Items in both PRO instruments could be amended/added to ensure conceptual comprehensiveness.