Oliver Sartor1, Emuella Flood2, Kathleen Beusterien3, Josephine Park4, Iain Webb4, David MacLean4, Bruce J O Wong5, H Mark Lin4. 1. Departments of Medicine and Urology, Tulane Medical School, New Orleans, LA. 2. Oxford Outcomes Inc, an ICON plc company, Bethesda, MD. Electronic address: emuella.flood@oxfordoutcomes.com. 3. Oxford Outcomes Inc, an ICON plc company, Bethesda, MD. 4. Millennium Pharmaceuticals Inc, The Takeda Oncology Company, Cambridge, MA. 5. Bruce Wong & Associates Inc.
Abstract
INTRODUCTION: This study aimed to examine the impact of advanced prostate cancer and its treatments on patients' perceptions of their health and to better understand concerns not captured by currently available health-related quality of life (HRQL) instruments. PATIENTS AND METHODS: Open ended one-on-one interviews were conducted with patients with prostate cancer who had biochemical failure or metastatic cancer to understand the impacts of disease and treatments on patients' perceptions of their lives. Interviews with 25 patients (7 biochemical failure and 18 metastatic) and 6 clinicians were conducted. Patient responses were analyzed to assess whether information saturation (ie, the point at which no new information is collected) was attained and compared with currently available HRQL instruments. The data informed the development of a comprehensive conceptual model illustrating the impacts of advanced disease and treatments. Clinical expert interviews also informed the conceptual model. RESULTS: Patients with prostate cancer reported many of the key symptoms already captured by current measures, such as bone pain, urinary functioning, bowel functioning, and fatigue. However, a number of impacts reported as bothersome by patients were identified that are not fully captured by existing HRQL measures. Specific examples include genital atrophy, muscle atrophy, stamina, body image, and emotional well-being. CONCLUSION: The conceptual model identified herein describes the impacts of prostate cancer and its treatments from the patient's perspective. The model can be useful in identifying key concepts important to patients that should be measured in trials to capture treatment benefits. The model also can help inform the selection of patient-reported outcomes to assess these benefits.
INTRODUCTION: This study aimed to examine the impact of advanced prostate cancer and its treatments on patients' perceptions of their health and to better understand concerns not captured by currently available health-related quality of life (HRQL) instruments. PATIENTS AND METHODS: Open ended one-on-one interviews were conducted with patients with prostate cancer who had biochemical failure or metastatic cancer to understand the impacts of disease and treatments on patients' perceptions of their lives. Interviews with 25 patients (7 biochemical failure and 18 metastatic) and 6 clinicians were conducted. Patient responses were analyzed to assess whether information saturation (ie, the point at which no new information is collected) was attained and compared with currently available HRQL instruments. The data informed the development of a comprehensive conceptual model illustrating the impacts of advanced disease and treatments. Clinical expert interviews also informed the conceptual model. RESULTS:Patients with prostate cancer reported many of the key symptoms already captured by current measures, such as bone pain, urinary functioning, bowel functioning, and fatigue. However, a number of impacts reported as bothersome by patients were identified that are not fully captured by existing HRQL measures. Specific examples include genital atrophy, muscle atrophy, stamina, body image, and emotional well-being. CONCLUSION: The conceptual model identified herein describes the impacts of prostate cancer and its treatments from the patient's perspective. The model can be useful in identifying key concepts important to patients that should be measured in trials to capture treatment benefits. The model also can help inform the selection of patient-reported outcomes to assess these benefits.
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