Nikunj Patel1, Xandra Lie2, Chad Gwaltney3, Nana Rokutanda4, Afsaneh Barzi5, Davide Melisi6,7, Teresa Macarulla8,9, Makoto Ueno10, Seung Tae Kim11, Oren Meyers12, Christina Workman4, Melinda Bachini13, Gordon Cohen4. 1. AstraZeneca, 1 Medimmune Way, Gaithersburg, MD, 20878, USA. nikunj.patel@astrazeneca.com. 2. IQVIA, Amsterdam, The Netherlands. 3. Gwaltney Consulting, Westerly, RI, USA. 4. AstraZeneca, Gaithersburg, MD, USA. 5. City of Hope Comprehensive Cancer Center, Duarte, CA, USA. 6. Digestive Molecular Clinical Oncology Unit, Università degli Studi di Verona, Verona, Italy. 7. Experimental Cancer Medicine Unit, Azienda Ospedaliera Integrata di Verona, Verona, Italy. 8. Vall d'Hebron University Hospital, Barcelona, Spain. 9. Vall d'Hebron Institute of Oncology, Barcelona, Spain. 10. Department of Gastroenterology, Kanagawa Cancer Center, Yokohama, Japan. 11. Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea. 12. IQVIA, New York, NY, USA. 13. Cholangiocarcinoma Foundation, Riverton, UT, USA.
Abstract
INTRODUCTION: Patients living with biliary tract cancer (BTC) experience a decline in health-related quality of life (HRQoL). This study aimed to obtain a comprehensive understanding of the patient experience of BTC-related signs/symptoms and the impacts of these on daily functioning and HRQoL. METHODS: Patients with BTC participated in qualitative semi-structured concept elicitation interviews. Signs/symptoms and impacts of BTC were initially explored by targeted literature searches and interviews with five clinicians. Patient interviews were transcribed and coded using qualitative research software. Concept saturation was assessed over five interview waves. A sign/symptom or impact was defined as "salient" if mentioned by ≥ 50% of patients, with a mean disturbance rating of ≥ 5 (0-10 scale). A conceptual model of the patient experience of BTC-related signs/symptoms and impacts was produced. RESULTS: Twenty-three patients from the USA (78% women; median age: 54 years), diagnosed as having early (n = 3), locally advanced (n = 11) or metastatic (n = 9) disease, were interviewed. Sixty-six signs/symptoms and 12 impacts were identified. Of these, 46 signs/symptoms and 8 impacts were not identified from the targeted literature or clinician interviews. Concept saturation was reached by the fourth of five interview waves. Fourteen disease-related signs/symptoms (including fatigue/lack of energy, abdominal pain, lack of appetite, insomnia and diarrhoea) and three impacts (physical, emotional and cognitive impacts) were deemed "salient". The conceptual model included 50 signs/symptoms and 12 impacts. CONCLUSION: Patients with BTC reported a range of signs/symptoms and impacts that negatively affect daily functioning and HRQoL.
INTRODUCTION:Patients living with biliary tract cancer (BTC) experience a decline in health-related quality of life (HRQoL). This study aimed to obtain a comprehensive understanding of the patient experience of BTC-related signs/symptoms and the impacts of these on daily functioning and HRQoL. METHODS:Patients with BTC participated in qualitative semi-structured concept elicitation interviews. Signs/symptoms and impacts of BTC were initially explored by targeted literature searches and interviews with five clinicians. Patient interviews were transcribed and coded using qualitative research software. Concept saturation was assessed over five interview waves. A sign/symptom or impact was defined as "salient" if mentioned by ≥ 50% of patients, with a mean disturbance rating of ≥ 5 (0-10 scale). A conceptual model of the patient experience of BTC-related signs/symptoms and impacts was produced. RESULTS: Twenty-three patients from the USA (78% women; median age: 54 years), diagnosed as having early (n = 3), locally advanced (n = 11) or metastatic (n = 9) disease, were interviewed. Sixty-six signs/symptoms and 12 impacts were identified. Of these, 46 signs/symptoms and 8 impacts were not identified from the targeted literature or clinician interviews. Concept saturation was reached by the fourth of five interview waves. Fourteen disease-related signs/symptoms (including fatigue/lack of energy, abdominal pain, lack of appetite, insomnia and diarrhoea) and three impacts (physical, emotional and cognitive impacts) were deemed "salient". The conceptual model included 50 signs/symptoms and 12 impacts. CONCLUSION:Patients with BTC reported a range of signs/symptoms and impacts that negatively affect daily functioning and HRQoL.
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