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Abstract Details
Understanding the patient experience in hepatocellular carcinoma: a qualitative patient interview study
Qual Life Res. 2021 Jun 11. doi: 10.1007/s11136-021-02903-4. Online ahead of print.
Nikunj Patel1, Joshua Maher2, Xandra Lie3, Chad Gwaltney4, Afsaneh Barzi5, Mark Karwal6, Teresa Macarulla7, Hui-Chuan Sun8, Jörg Trojan9, Oren Meyers10, Christina Workman11, Shethah Morgan12, Alejandra Negro11, Gordon Cohen11
Author information
1AstraZeneca, 1 Medimmune Way, Gaithersburg, MD, 20878, USA. nikunj.patel@astrazeneca.com.
2IQVIA, Reading, UK.
3IQVIA, Amsterdam, The Netherlands.
4Gwaltney Consulting, Westerly, RI, USA.
5City of Hope Comprehensive Cancer Center, Duarte, Los Angeles, CA, USA.
6University of IOWA Health Care, Iowa City, IA, USA.
7GI Unit Vall D´Hebron Hospital, Barcelona, Spain.
8Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China.
9Medical Department 1, Goethe University Medical Center, Frankfurt, Germany.
10IQVIA, New York, NY, USA.
11AstraZeneca, 1 Medimmune Way, Gaithersburg, MD, 20878, USA.
12AstraZeneca, Cambridge, UK.
Abstract
Purpose: This study aimed to elucidate the patient experience of hepatocellular carcinoma (HCC) to guide patient-centered outcome measurement in drug development.
Methods: Patients with HCC participated in qualitative interviews to elicit disease-related signs/symptoms and impacts, using discussion guides developed from literature searches and discussions with oncologists. Interview participants rated the disturbance of their experiences (0-10 scale). A conceptual model was developed and mapped against patient-reported outcome (PRO) instruments identified from database reviews.
Results: Interviews were conducted with 25 individuals with HCC (68% were men; median age: 63 years; 12% Barcelona clinic liver cancer (BCLC) stage A; 32% stage B; and 56% stage C) in the USA. Fifty-one HCC-related concepts were identified from the interviews and were grouped into eight sign/symptom categories (eating behavior/weight changes; extremities [arms, legs]; fatigue and strength; gastrointestinal; pain; sensory; skin; other) and four impact categories (emotional; physical; cognitive function; other) for the conceptual model. The most prevalent and disturbing experiences across the disease stages were fatigue/lack of energy and emotional impacts such as frustration, fear, and depression. Abdominal pain and skin-related issues were particularly common and disturbing in individuals with HCC stage C. The EORTC QLQ-C30 and HCC18 were identified as commonly used PRO instruments in HCC studies and captured the relevant signs/symptoms associated with the patient experience.
Conclusion: Patients with HCC reported a range of signs/symptoms and impacts that negatively affect daily functioning and quality of life. Including PRO measures in HCC clinical trials can provide meaningful patient perspectives during drug development.