title: Neurological complications of breast cancer: study protocol of a prospective cohort study.
abstract: BACKGROUND
  The improvement in breast cancer survival rates, along with the expected overdiagnosis and overtreatment associated with breast cancer screening, requires a comprehensive assessment of its burden. Neurological complications can have a devastating impact on these patients; neuropathic pain and chemotherapy-induced peripheral neuropathy are among the most frequently reported. This project aims to understand the burden of neurological complications of breast cancer treatment in Northern Portugal, and their role as mediator of the impact of the treatment in different dimensions of the patients' quality of life.
  
  
  METHODS
  A prospective cohort study was designed to include 500 patients with breast cancer, to be followed for 3 years. The patients were recruited at the Portuguese Oncology Institute of Porto and evaluations were planned at different stages: pretreatment, after surgery, after chemotherapy (whenever applicable) and at 1 and 3 years after enrolment. Patients diagnosed with neuropathic pain or chemotherapy-induced peripheral neuropathy (subcohorts), were also evaluated at the moment of confirmation of clinical diagnosis of the neurological complication and 6 months later. In each of the follow-up periods, a neurological examination has been performed by a neurologist. Data were collected on sociodemographic and clinical characteristics, quality of life, sleep quality, and anxiety and depression. Between January and December 2012, we recruited and conducted the baseline evaluation of 506 participants. The end of the follow-up period is scheduled for December 2015.
  
  
  BACKGROUND
  The study protocol was approved by the Ethics Committee of the Portuguese Oncology Institute of Porto and all patients provided written informed consent. All study procedures were developed in order to assure data protection and confidentiality. Results from this project will be disseminated in international peer-reviewed journals and presented in relevant conferences.
authors.affiliation: Instituto Português de Oncologia, Porto, Portugal.|EPI Unit, Instituto de Saúde Pública da Universidade do Porto (ISPUP), Porto, Portugal.|Departamento de Epidemiologia Clínica, Medicina Preditiva e Saúde Pública, Faculdade de Medicina, Universidade do Porto, Porto, Portugal.
authors.forename: Susana
authors.initials: S
authors.lastname: Pereira
authors.affiliation: EPI Unit, Instituto de Saúde Pública da Universidade do Porto (ISPUP), Porto, Portugal.|Departamento de Epidemiologia Clínica, Medicina Preditiva e Saúde Pública, Faculdade de Medicina, Universidade do Porto, Porto, Portugal.
authors.forename: Filipa
authors.initials: F
authors.lastname: Fontes
authors.affiliation: Instituto Português de Oncologia, Porto, Portugal.
authors.forename: Teresa
authors.initials: T
authors.lastname: Sonin
authors.affiliation: Instituto Português de Oncologia, Porto, Portugal.
authors.forename: Teresa
authors.initials: T
authors.lastname: Dias
authors.affiliation: Instituto Português de Oncologia, Porto, Portugal.
authors.forename: Maria
authors.initials: M
authors.lastname: Fragoso
authors.affiliation: Departamento de Biologia Experimental, Faculdade de Medicina, Universidade do Porto, Porto, Portugal.|Instituto de Biologia Molecular e Celular (IBMC), Universidade do Porto, Porto, Portugal.
authors.forename: José
authors.initials: J
authors.lastname: Castro-Lopes
authors.affiliation: EPI Unit, Instituto de Saúde Pública da Universidade do Porto (ISPUP), Porto, Portugal.|Departamento de Epidemiologia Clínica, Medicina Preditiva e Saúde Pública, Faculdade de Medicina, Universidade do Porto, Porto, Portugal.
authors.forename: Nuno
authors.initials: N
authors.lastname: Lunet
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000150:complications / Q000188:drug therapy*; D015331:Cohort Studies; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D009437:Neuralgia / Q000139:chemically induced*; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced*; D011174:Portugal; D011446:Prospective Studies; D011788:Quality of Life
chemical_list: D000970:Antineoplastic Agents
keywords: EPIDEMIOLOGY