Abstract

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.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 7days. HRQL was assessed using the generic instrument SF-36 and the specific one FACT-B+4.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.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.

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