Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer (FACT-B+4). Spanish version validation

Background and objectives: To evaluate the acceptability, reliability, validity, and sensitivity to change of the Spanish version of the FACT-B+4 questionnaire, designed to assess the health related quality of life (HRQL) in breast cancer. Patients and methods: Prospective study with 2 samples: patients with incident breast cancer (n = 104) evaluated before and after surgery; and patients with chronic lymphedema of the upper extremity (n = 30), evaluated twice in 7 days. HRQL was assessed using the generic instrument SF-36 and the specific one FACT-B+4. Results: Reliability coefficients were >= 0.7 for most scores. The Physical wellbeing, Breast Cancer, Arm and TOI scores discriminated between patients with and without chemotherapy (p < 0.05). while the Arm scale discriminated between patients with and without axillary surgery (p < 0.001). In the worsening sub-sample, the FACT-B+4 detected changes in Physical, Emotional and Functional Wellbeing, and TOI scores. Conclusions: The metric characteristics of the Spanish version of the FACT-B+4 are similar to the original questionnaire and support its equivalence, documenting its suitability for use in our country or in international studies. (C) 2010 Elsevier Espana, S.L. All rights reserved.