title: Health-related quality of life in advanced prostate cancer and its treatments: biochemical failure and metastatic disease populations.
abstract: BACKGROUND
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Departments of Medicine and Urology, Tulane Medical School, New Orleans, LA.
authors.forename: Oliver
authors.initials: O
authors.lastname: Sartor
authors.affiliation: Oxford Outcomes Inc, an ICON plc company, Bethesda, MD. Electronic address: emuella.flood@oxfordoutcomes.com.
authors.forename: Emuella
authors.initials: E
authors.lastname: Flood
authors.affiliation: Oxford Outcomes Inc, an ICON plc company, Bethesda, MD.
authors.forename: Kathleen
authors.initials: K
authors.lastname: Beusterien
authors.affiliation: Millennium Pharmaceuticals Inc, The Takeda Oncology Company, Cambridge, MA.
authors.forename: Josephine
authors.initials: J
authors.lastname: Park
authors.affiliation: Millennium Pharmaceuticals Inc, The Takeda Oncology Company, Cambridge, MA.
authors.forename: Iain
authors.initials: I
authors.lastname: Webb
authors.affiliation: Millennium Pharmaceuticals Inc, The Takeda Oncology Company, Cambridge, MA.
authors.forename: David
authors.initials: D
authors.lastname: MacLean
authors.affiliation: Bruce Wong & Associates Inc.
authors.forename: Bruce J O
authors.initials: BJ
authors.lastname: Wong
authors.affiliation: Millennium Pharmaceuticals Inc, The Takeda Oncology Company, Cambridge, MA.
authors.forename: H
authors.initials: H
authors.lastname: Mark Lin
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D003625:Data Collection; D006304:Health Status; D006801:Humans; D008297:Male; D008875:Middle Aged; D008962:Models, Theoretical; D009362:Neoplasm Metastasis; D017430:Prostate-Specific Antigen / Q000378:metabolism; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology* / Q000523:psychology; D011788:Quality of Life / Q000523:psychology*
chemical_list: D017430:Prostate-Specific Antigen
keywords: Conceptual model; Interviews; PRO; Patient perspective; Patient-reported outcome