Abstract
BackgroundHealth-related quality of life (HRQoL) is greatly affected by prostate cancer (PCa) and associated treatments. This study aimed to measure the impact of radiotherapy on HRQoL and to further validate the Spanish version of the 16-item Expanded Prostate Cancer Index Composite (EPIC-16) in routine clinical practice.MethodsAn observational, non-interventional, multicenter study was conducted in Spain with localized PCa patients initiating treatment with external beam radiotherapy (EBRT) or brachytherapy (BQT). Changes from baseline in EPIC-16, University of California-Los Angeles Prostate Cancer Index (UCLA-PCI), and patient-perceived health status were longitudinally assessed at end of radiotherapy (V2) and 90 days thereafter (V3). Psychometric evaluations of the Spanish EPIC-16 were conducted.ResultsOf 516 patients enrolled, 495 were included in the analysis (EBRT, n = 361; BQT, n = 134). At baseline, mean (standard deviation [SD]) EPIC-16 global scores were 11.9 (7.5) and 10.3 (7.7) for EBRT and BQT patients, respectively; scores increased, i.e., HRQoL worsened, from baseline, by mean (SD) of 6.8 (7.6) at V2 and 2.4 (7.4) at V3 for EBRT and 4.2 (7.6) and 3.9 (8.2) for BQT patients. Changes in Spanish EPIC-16 domains correlated well with urinary, bowel, and sexual UCLA-PCI domains. EPIC-16 showed good internal consistency (Cronbach’s alpha = .84), reliability, and construct validity.ConclusionThe Spanish EPIC-16 questionnaire demonstrated sensitivity, strong discriminative properties and reliability, and validity for use in clinical practice. EPIC-16 scores worsened after radiotherapy in different HRQoL domains; however, a strong tendency towards recovery was seen at the 3-month follow-up visit.
Highlights
Health-related quality of life (HRQoL) is greatly affected by prostate cancer (PCa) and associated treat‐ ments
These instruments were mostly designed for use in the research field and they are too lengthy and time consuming to be used in clinical practice, which limits the ability of physicians who treat PCa to accurately assess HRQoL and optimally individualize treatment-related decisions
Expanded Prostate Cancer Index Composite (EPIC)-16 scores worsened after radiotherapy in different HRQoL domains, regardless of patients’ perceptions of their health status, suggesting that patients did not perceive the change in functional domains as a global change in their health status
Summary
Health-related quality of life (HRQoL) is greatly affected by prostate cancer (PCa) and associated treat‐ ments. A wellestablished instrument that is frequently used to assess a patient’s post-intervention-related HRQoL is the 50-item Expanded Prostate Cancer Index Composite (EPIC) questionnaire, which was developed based on the University of California-Los Angeles Prostate Cancer Index (UCLA-PCI) [6, 7] These instruments were mostly designed for use in the research field and they are too lengthy and time consuming to be used in clinical practice, which limits the ability of physicians who treat PCa to accurately assess HRQoL and optimally individualize treatment-related decisions. This will enable a less time-consuming evaluation of treatment-related HRQoL
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