Exploring the patient experience of locally advanced or metastatic pancreatic cancer to inform patient-reported outcomes assessment

Joseph M Herman; Helen Kitchen; Arnold Degboe; Natalie V J Aldhouse; Andrew Trigg; Mary Hodgin; Amol Narang; Colin D Johnson

doi:10.1007/s11136-019-02233-6

Exploring the patient experience of locally advanced or metastatic pancreatic cancer to inform patient-reported outcomes assessment

Qual Life Res. 2019 Nov;28(11):2929-2939. doi: 10.1007/s11136-019-02233-6. Epub 2019 Jul 4.

Authors

Joseph M Herman¹, Helen Kitchen², Arnold Degboe³, Natalie V J Aldhouse², Andrew Trigg⁴, Mary Hodgin⁵, Amol Narang¹, Colin D Johnson⁶

Affiliations

¹ Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, MD, USA.
² DRG Abacus, Clinical Outcomes Assessment, Manchester, UK.
³ AstraZeneca, Gaithersburg, MD, USA.
⁴ Adelphi Values, Macclesfield, UK.
⁵ Department of Surgery, Advanced Practice Nursing, Johns Hopkins University, Baltimore, MD, USA.
⁶ Surgical Unit, University of Southampton, Southampton, SO16 6YD, UK. c.d.johnson@soton.ac.uk.

Abstract

Purpose: Pancreatic 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.

Methods: Qualitative 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.

Results: Patients 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.

Conclusions: This 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.

Keywords: Disease conceptual model; Oncology; Pancreatic cancer; Patient experience; Patient-reported outcome (PRO); Qualitative research.

MeSH terms

Adult
Aged
Aged, 80 and over
Female
Humans
Male
Middle Aged
Neoplasm Metastasis
Pancreatic Neoplasms / epidemiology*
Pancreatic Neoplasms / psychology*
Patient Reported Outcome Measures*
Quality of Life / psychology*
Surveys and Questionnaires