Abstract
PurposePancreatic cancer and its treatments impact patients’ symptoms, functioning, and quality of life. Content-valid patient-reported outcome (PRO) instruments are required to assess outcomes in clinical trials. This study aimed to: (a) conceptualise the patient experience of pancreatic cancer; (b) identify relevant PRO instruments; (c) review the content validity of mapped instruments to guide PRO measurement in clinical trials.MethodsQualitative literature and interviews with clinicians and patients were analysed thematically to develop a conceptual model of patient experience. PRO instruments were reviewed against the conceptual model to identify gaps in measurement. Cognitive debriefing explored PRO conceptual relevance and patients’ understanding.ResultsPatients in the USA (N = 24, aged 35–84) and six clinicians (from US and Europe) were interviewed. Pre-diagnosis, pain was the most frequently reported symptom (N = 21). Treatments included surgery, radiation, chemotherapy, and immunotherapy. Surgery was associated with acute pain and gastrointestinal symptoms. Chemotherapy/chemoradiation side effects were cyclical and included fatigue/tiredness (N = 21), appetite loss (N = 15), bowel problems (N = 15), and nausea/vomiting (N = 15). Patients’ functioning and well-being were impaired. The literature review identified 49 PRO measures; the EORTC QLQ-C30/PAN26 were used most frequently and mapped with interview concepts. Patients found the EORTC QLQ-C30/PAN26 to be understandable and relevant; neuropathic side effects were suggested additions.ConclusionsThis is the first study to develop a conceptual model of patients’ experience of metastatic/recurrent pancreatic cancer and explore the content validity of the EORTC QLQ-C30/PAN26 following therapeutic advances. The EORTC QLQ-C30/PAN26 appears conceptually relevant; additional items to assess neuropathic side effects are recommended. A recall period should be stated throughout to standardise responses.
Highlights
Pancreatic cancer is the fourth or fifth highest cause of cancer-related deaths in most developed countries [1]
Patient-reported outcome (PRO) instruments are increasingly important for assessing outcomes in pancreatic cancer care and research [5] directly from the patient perspective and provide important information to evaluate outcomes in clinical trials [6]
The findings of this study indicate that the EORTC QLQ-C30 pain scale and PAN26 pancreatic pain scale are both salient to measure in this population
Summary
Pancreatic cancer is the fourth or fifth highest cause of cancer-related deaths in most developed countries [1]. Pancreatic cancer and its treatment have a negative impact on patients’ functioning, well-being and other aspects of health related quality of life (HRQoL) [3, 4]. Patient-reported outcome (PRO) instruments are increasingly important for assessing outcomes in pancreatic cancer care and research [5] directly from the patient perspective and provide important information to evaluate outcomes in clinical trials [6]. PRO instruments vary significantly with respect to their development and validation and there are many factors to consider when selecting a PRO instrument including target population characteristics (e.g. tumour location, disease stage), treatment, timing of assessment, clinical setting, study purpose, the research question, and how well the PRO instrument assesses symptoms and impacts that are meaningful to patients. The content validity and psychometric properties of a PRO instrument should be well understood within the population of interest and context of use [7,8,9]
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