Quality of life in long-term premenopausal early-stage breast cancer survivors from Spain. Effects of surgery and time since surgery.

PURPOSE: More research is needed into Quality of Life (QoL) in young early-stage breast cancer patients in the long-term. Knowledge of long-term effects of surgery on QoL in breast cancer patients is limited. The purpose of this study was to assess QoL in premenopausal Spanish early- stage breast cancer patients over a long follow-up period and evaluate differences among surgery-treated groups and the influence of time on patient QoL. METHODS: 243 premenopausal stage I-III relapse-free breast cancer patients completed the EORTC QLQ-C30 and QLQ-BR23 questionnaire once during follow-up (5-20 years after surgery). Univariate and multivariate logistic regression analyses were performed to estimate the results. RESULTS: QoL mean scores were high in most areas (>80 points in functioning: <20 points in symptoms areas). Limitations were moderate (>30 points) in global QoL, sleep disturbance, future perspective, sexual areas, and hot flashes. Mastectomized patients had a 4-fold greater risk of low scores in body image. Patients with a longer follow-up showed lower systemic side effects, hot flashes and breast symptoms. CONCLUSIONS: QoL in Spanish premenopausal early-stage breast cancer patients in a long follow-up after surgery is high. Differences in QoL among surgery-treated groups are limited. Time since surgery influences treatment side effects.

International Psychometric Validation of an EORTC Quality of Life Module Measuring Cancer Related Fatigue (EORTC QLQ-FA12).

Background: The European Organisation for Research and Treatment of Cancer (EORTC) Group has developed a new multidimensional instrument measuring cancer-related fatigue to be used in conjunction with the quality of life core questionnaire (EORTC QLQ-C30). The module EORTC QLQ-FA13 assesses physical, cognitive, and emotional aspects of cancer-related fatigue. Methods: The methodology follows the EORTC guidelines for phase IV validation of modules. This paper focuses on the results of the psychometric validation of the factorial structure of the module. For validation and cross-validation confirmatory factor analysis (maximum likelihood estimation), intraclass correlation and Cronbach alpha for internal consistency were employed. The study involved an international multicenter collaboration of 11 European and non-European countries. Results: A total of 946 patients with various tumor diagnoses were enrolled. Based on the confirmatory factor analysis, we could approve the three-dimensional structure of the module. Removing one item and reassigning the factorial mapping of another item resulted in the EORTC QLQ-FA12. For the revised scale, we found evidence supporting good local (indicator reliability ≥ 0.60, factor reliability ≥ 0.82) and global model fit (GFI t1|t2 = 0.965/0.957, CFI t1|t2 = 0.976/0.972, RMSEA t1|t2 = 0.060/0.069) for both measurement points. For each scale, test-retest reliability proved to be very good (intraclass correlation: R t1-t2 = 0.905-0.921) and internal consistency proved to be good to high (Cronbach alpha = .79-.90). Conclusion: Based on the former phase III module, the multidimensional structure was revised as a phase IV module (EORTC FA12) with an improved scale structure. For a comprehensive validation of the EORTC FA12, further aspects of convergent and divergent validity as well as sensitivity to change should be determined.