TY - JOUR
T1 - Exploring the patient experience of locally advanced or metastatic pancreatic cancer to inform patient-reported outcomes assessment
AU - Herman, Joseph M.
AU - Kitchen, Helen
AU - Degboe, Arnold
AU - Aldhouse, Natalie V.J.
AU - Trigg, Andrew
AU - Hodgin, Mary
AU - Narang, Amol
AU - Johnson, Colin D.
N1 - Funding Information:
The authors would like to thank the study staff at Johns Hopkins University and the patients who participated in the interviews. The authors also acknowledge Louise Humphrey, Tom Willgoss, and Stephanie Meysner for their contributions to the design of this study. The authors would also like to thank Nikunj Patel for reviewing and providing input that greatly improved the quality of the manuscript. Hannah Pegram of DRG Abacus is acknowledged for medical writing support on the manuscript.
Funding Information:
Funding for this study was provided by AstraZeneca. Time for medical writing support was also funded by AstraZeneca and provided by DRG Abacus.
Publisher Copyright:
© 2019, The Author(s).
PY - 2019/11/1
Y1 - 2019/11/1
N2 - 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.
AB - 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.
KW - Disease conceptual model
KW - Oncology
KW - Pancreatic cancer
KW - Patient experience
KW - Patient-reported outcome (PRO)
KW - Qualitative research
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U2 - 10.1007/s11136-019-02233-6
DO - 10.1007/s11136-019-02233-6
M3 - Article
C2 - 31273624
AN - SCOPUS:85068850286
SN - 0962-9343
VL - 28
SP - 2929
EP - 2939
JO - Quality of Life Research
JF - Quality of Life Research
IS - 11
ER -