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Objective: The European Organisation for Research and Treatment of Cancer Quality of Life Group (EORTC QLG) has developed a multidimensional instrument measuring cancer-related fatigue, the EORTC QLQ-FA12. The analysis of sensitivity to change is an essential part of psychometric validation. With this study, we investigated the EORTC QLQ-FA12's sensitivity to change.Methods: The methodology follows the EORTC guidelines of EORTC QLG for phase IV validation of modules. We included cancer patients undergoing curative and palliative treatment at t1 and followed them up prospectively over the course of their treatment (t2) and 4 weeks after completion of treatment (t3). Data were collected prospectively at 17 sites in 11 countries. Sensitivity to change was investigated using analysis of variance.Results: A total sample of 533 patients was enrolled with various tumour types, different stages of cancer, and receiving either curative treatment (n=311) or palliative treatment (n=222). Over time all fatigue scores were significantly higher in the palliative treatment group compared with the curative group (p < .001). Physical fatigue increased with medium effect size over the course of treatment in the curative group (standardized response mean [SRM] (t1,t2) = 0.44]. After treatment physical [SRM (t2,t3) = 0.39], emotional [SRM (t2,t3)= 0.28] and cognitive fatigue (SRM [t2,t3] = 0.22) declined significantly in the curative group. In the palliative group, emotional (SRM [t2,t3] = 0.18) as well as cognitive [SRM [t2,t3] = 0.26) fatigue increases significantly.Conclusions: The EORTC-QLQ-FA12 proved to identify clinically significant changes in fatigue in the course of curative and palliative cancer treatment. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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., (© The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.)

Purpose: Assessment of health-related quality of life (HRQOL) is critical to effective delivery of palliative care in patients with advanced cancer. The current study analyzes relationships between baseline social determinants of health and medical factors, and self-reported HRQOL in patients with bone metastases receiving palliative radiotherapy., Methods and Materials: Advanced cancer patients referred for radiotherapy treatment of bone metastases completed the EORTC QLQ-C30 questionnaire in multiple outpatient clinics internationally. Demographics and social determinants were collected as baseline information. Univariate and Bonferroni-adjusted multivariate linear regression analyses were used to detect significant correlations between baseline determinants and different HRQOL domains., Results: Karnofsky Performance Status (KPS) was correlated with better physical (p = 0.0002), role (p < 0.0001), emotional (p < 0.0001), and social (p < 0.0001) functioning, and global health scores (p = 0.0015) and predicted lower symptom scores for fatigue (p < 0.0001), pain (p < 0.0001), appetite loss (p < 0.0001), and constipation (p < 0.0001). Increased age was predictive of better social functioning (p < 0.0001) and less insomnia (p = 0.0036), higher education correlated with better global health status (p = 0.0043), and patients who were employed or retired had improved physical functioning (p = 0.0004 and p = 0.0030, respectively) and less financial challenges compared to patients who were unemployed (p = 0.0005)., Conclusions: Baseline KPS had the greatest influence on EORTC QLQ-C30 domain scores. Age, education level, and employment status had significant impacts, although on fewer domains. Further studies that investigate baseline determinants are worthwhile to clarify relationships in order to care for patients more effectively at the end of life.

Objective: The European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 15 Palliative (EORTC QLQ-C15-PAL) was developed to assess quality of life (QOL) for the palliative cancer population to decrease patient burden. The purpose of this study was to compare predictive factors for well-being in the QLQ-C15-PAL extracted from the EORTC Quality of Life Questionnaire - Core 30 (QLQ-C30) with the QLQ-C30 itself., Methods and Materials: Patients with advanced cancer referred for treatment of bone metastases completed the QLQ-C30. Fifteen items from the QLQ-C15-PAL were extracted from the QLQ-C30. Univariate and multivariate analyses were used to determine predictive factors of the global QOL/health score in both tools. In the multivariate analyses, a p value of <0.003 indicated statistical significance., Results: Overall, predictive factors were similar when analyzing data from both tools. Predictive factors for the QLQ-C30 were role functioning (p<0.0001), fatigue (p<0.0001), nausea/vomiting (p<0.0001), and financial problems (p<0.0001) and factors for the extracted QLQ-C15-PAL were physical functioning (p<0.0001) and fatigue (p<0.0001)., Conclusions: Extraction of the QLQ-C15-PAL items from the QLQ-C30 resulted in similar predictive QOL domains for all patient subgroups analyzed individually. The QLQ-C15-PAL is reflective of the QLQ-C30 domains and is recommended for future studies involving patients in a palliative setting, as this shorter questionnaire reduces patient burden and may increase accrual and compliance, while maintaining a similar breadth of coverage and achieving the same predictive ability.

Purpose: Quality of life (QOL) is frequently an endpoint in clinical trials involving patients with advanced cancer. Statistical significance of minimal differences can be achieved with sufficient sample size, yet the actual clinical relevance is unknown. The purpose of this study was to establish the minimal clinically important difference (MCID) for the European Organisation for Research and Treatment of Cancer (EORTC) bone metastases module (EORTC QLQ-BM22)., Methods: Patients with bone metastases across seven countries were prospectively enrolled in a trial validating the EORTC QLQ-BM22 and completed the QLQ-BM22 and core measure (QLQ-C30) at baseline and 1-month follow-up. MCIDs were calculated for each QOL scale for both improvement and deterioration using both an anchor- (performance status) and distribution-based approach., Results: A total of 93 patients completed both baseline and follow-up QOL and had recorded performance status at both intervals. Statistically significant meaningful differences were seen in seven scales. There were improvements of 30.5 (95 % confidence interval, 9.0 to 52.0), 20.1 (7.1 to 33.2), 30.5 (13.8 to 47.3) and 19.6 (5.0 to 34.3) in the pain, painful site, painful characteristic and functional interference scales, respectively, demonstrated clinical relevance. Decreases of 12.4 (0.3 to 24.6), 22.4 (11.8 to 32.9) and 13.5 (1.9 to 25.1) were required to represent clinically relevant deterioration in emotional functioning, global health status and financial issues, respectively. Minimal differences for improvement were closest to 0.5 standard deviations (SD) while for deterioration, closer to 0.3 SD on the QLQ-BM22., Conclusion: Identification of requirements for clinical significance can assist in determining the relevance of QOL changes after treatment and in sample size determination in future trials. Our study is limited by the small sample size. Future studies should continue to determine MCID and confirm our findings using a variety of appropriate anchors and in a larger sample.

Background: To evaluate diagnosis, management and outcome of breast cancer (BC) occurring after irradiation for Hodgkin's lymphoma (HL)., Methods: 39 cases of BC in 28 HL survivors were retrospectively reviewed. 21 patients were included in a case-control analysis., Results: The median age at diagnosis of HL and BC was 25.3 and 45.3 years, respectively. The median interval to develop BC was 16.1 years. Eleven women (39.2%) had bilateral disease. Mode of detection of the index breast cancers was by mammographic screening in 17 patients (60.7%), palpable lump in 8 patients (28.6%), clinical examination in two patients (7.1%), and unknown in one patient (3.6%). Case-control analysis showed that histological features and prognosis of BC after HL were similar to those of primary BC, however, for BC after HL, mastectomy was the predominant surgery (P = .001) and adjuvant radiotherapy and anthracycline-based chemotherapy were less frequently used as compared to primary BC (P < .001 and .003, respectively)., Conclusion: The previous history of HL does not appear to be a poor prognostic factor for BC occurring thereafter.