Objective:

The purpose of this article is to describe the PeOpLe study protocol, developed to assess patient-reported health outcomes in advanced or metastatic non-small-cell lung cancer in routine clinical practice using the methodology provided by the International Consortium for Health Outcomes Measurement tool.

Method:

The study envisaged will be multicenter, longitudinal, ambispective and observational. Two groups will be compared: a control group (followed up according to standard clinical practice) and an experimental group (followed up using the International Consortium for Health Outcomes Measurement methodology adapted to the Spanish setting for 6 months). The variables collected will be related to demography (age, sex, degree of family support), clinical factors (smoking, comorbidities, lung capacity), the neoplasm (histology, staging, mutations), pharmacotherapy (treatment schedule, modifications, and complications), health status (functional status, quality of life, satisfaction and overall survival) and resource con. sumption (emergency visits, hospital admissions and time spent by health providers). The PeOpLe study protocol has been approved by the Ethics Committee for Research into Medicinal Products of the Gregorio Marañón General University Hospital and will be conducted in compliance with prevailing ethical principles and standards.

Conclusions:

The PeOpLe study will explore how patient-reported outcomes collection can be developed and integrated with the clinical processes used in the management of patients with locally advanced or metastatic nonsmall cell lung cancer what patient-reported outcomes can be measured with systems that can conveniently be used both by patients and by healthcare providers. Systematic evaluation of patient-reported outcomes will help determine their impact in terms of effectiveness (survival), safety (complications of systemic therapy), and quality of life and patient satisfaction. The multidisciplinary and multicenter nature of the study will facilitate a comprehensive view of the subject analyzed and allow external reproducibility.