Verena Meraner

Normative data for functional assessment of cancer therapy General scale and its use for the interpretation of quality of life scores in cancer survivors

The aims of this study were to derive population-based reference values for the Functional Assessment of Cancer Therapy Scale–General (FACT-G) and to investigate the impact of sociodemographic variables (e.g. age, sex, health status) on these quality of life (QOL) scores, and to compare the normative QOL scores with those of various groups of cancer survivors. A random sample of 2 000 members of the Austrian public were sent questionnaires containing the FACT-G and questions relating to demographic data and health status. A total of 968 questionnaires were returned giving an overall response rate of 50.6% (females 48.3%, age 49.3±16.8). Subjects with higher education reported higher QOL values; divorced and widowed persons had significantly lower QOL scores. Higher age was also associated with lower QOL scores. After bone marrow transplantation, patients generally showed lower QOL scores than the age- and sex-matched population-based sample, whilst in breast cancer survivors there was reduced QOL regarding social well-being. Survivors of Hodgkins disease were found to have higher functional and social well-being scores than those of the general population sample. Sociodemographic variables should always be taken into consideration when interpreting QOL scores. Furthermore, unless patient data are compared with normative values, phenomena such as adaptation and response shift might be missed or misinterpreted.

Fatigue in ovarian carcinoma patients: A neglected issue?

Although fatigue is a commonly reported symptom in cancer patients it is rarely investigated, especially in patients with ovarian carcinoma. The main focus of the current study was to assess fatigue in these patients and to investigate the impact of fatigue and other clinical and psychosocial variables on their quality of life (QOL).

Quality of life in adult hematopoietic cell transplant patients at least 5 yr after treatment : a comparison with healthy controls

Abstract:  Background and objective: As long‐term survivors of hematopoietic cell transplantation (HCT) become more numerous, studies addressing the issue of long‐term follow‐up are necessary. In this study, we report on the quality of life (QOL) of HCT‐patients, who were alive at least at 5 yr after transplantation in comparison to an age‐ and sex‐matched sample of healthy controls assessed in the same time‐period and the same geographical region. Design and methods: The European Group of Research and Treatment of Cancer (EORTC)‐QOL Questionnaire (EORTC‐QLQ C30) was sent by post to 39 HCT‐survivors. Thirty‐four patients answered the questionnaire. Patients were compared with 68 healthy controls from the same geographical region. Patients and controls completed the EORTC in the same time period. Results: Mann–Whitney U‐tests identified significantly lower QOL on the dimensions of physical and social functioning and on the financial impact symptom scale. Conclusions: Patients who had survived their HCT for more than 5 yr did generally well in terms of global QOL. This is consistent with Kiss et al. (J Clin Oncol 2002;20:2334–2343), who found that chronic myeloid leukemia patients who were alive at least 10 yr after HCT report lower physical functioning in comparison to healthy controls. Problems in the areas of social functioning and financial difficulty can possibly be addressed by intensive rehabilitation processes integrating patients, family members and significant others. Interdisciplinary (medical, psychological and social) treatment of patients should not come to an end after the acute phase of the illness but should continue during check‐ups following transplantation.

Enhanced tryptophan degradation in patients with ovarian carcinoma correlates with several serum soluble immune activation markers

Tryptophan-degrading enzyme indoleamine 2,3-dioxygenase (IDO) represents an antimicrobial and antitumoral immune effector mechanism, but IDO also suppresses T-cell responses and thus can cause immune system failure. Therefore, IDO was proposed as an immunoescape mechanism of tumor cells. Compared to healthy controls, accelerated tryptophan degradation was observed in the blood of 20 patients with ovarian carcinoma as is reflected by an increased kynurenine to tryptophan ratio (kyn/trp) which allows an estimate of IDO activity. Higher FIGO stage but not tumor grading was associated with a higher rate of tryptophan degradation. Kyn/trp correlated strongly with concentrations of cytokine IL-6, of soluble interleukin-2 receptor-α and 75 kDa TNF-α receptor and of the macrophage marker neopterin (all p<0.001 or p<0.01) but not with TNF-α. Findings further supports the concept that increased IDO activity in ovarian cancer patients relates to immune activation pathways. Accordingly, accelerated tryptophan degradation appears to represent an immune escape mechanism. However IDO activity is not necessarily a spontaneous activity of ovarian cancer cells rather it is elicited by the activated immune system although an additional spontaneous activity of tumor cells cannot be ruled out.

Monitoring physical and psychosocial symptom trajectories in ovarian cancer patients receiving chemotherapy

BackgroundDiagnosis and treatment of ovarian cancer (OC) entail severe symptom burden and a significant loss of quality of life (QOL). Somatic and psychological impairments may persist well beyond active therapy. Although essential for optimal symptom management as well as for the interpretation of treatment outcomes, knowledge on the course of QOL-related issues is scarce. This study aimed at assessing the course of depressive symptoms, anxiety, fatigue and QOL in patients with OC over the course of chemotherapy until early after-care.Methods23 patients were assessed longitudinally (eight time points) with regard to symptom burden (depression, anxiety, fatigue, and QOL) by means of patient-reported outcome instruments (HADS, MFI-20, EORTC QLQ-C30/-OV28) and clinician ratings (HAMA/D) at each chemotherapy cycle and at the first two aftercare visits.ResultsStatistically significant decrease over time was found for depressive symptoms and anxiety as well as for all fatigue scales. With regard to QOL, results indicated significant increase for 11 of 15 QOL scales, best for Social (effect size = 1.95; p < 0.001), Emotional (e.s. = 1.62; p < 0.001) and Physical Functioning (e.s. = 1.47; p < 0.001). Abdominal Symptoms (e.s. = 1.01; p = 0.009) decreased, Attitudes towards Disease and Treatment (e.s. = 1.80; p < 0.001) improved significantly over time. Analysis of Sexual Functioning was not possible due to a high percentage of missing responses (61.9%).ConclusionsThe present study underlines the importance of longitudinal assessment of QOL in order to facilitate the identification of symptom burden in OC patients. We found that patients show high levels of fatigue, anxiety and depressive symptoms and severely impaired QOL post-surgery (i.e. at start of chemotherapy) but condition improves considerably throughout chemotherapy reaching nearly general population symptoms levels until aftercare.

Adherence evaluation of endocrine treatment in breast cancer: methodological aspects

BackgroundCurrent studies on adherence to endocrine therapy in breast cancer patients suffer from methodological limitations due to a lack of well-validated methods for assessing adherence. There is no gold standard for measuring adherence. The aim of our study was to compare four different approaches for evaluating adherence to anastrozole therapy for breast cancer with regard to concordance between methods.MethodsOutpatients with early breast cancer treated with anastrozole completed the multi-method assessment of adherence. We implemented a self-report scale (the Simplified Medication Adherence Questionnaire), physician- ratings, refill records and determination of anastrozole serum concentration.ResultsComparison of the four approaches using Spearman rank correlation revealed poor concordance across all methods reflecting weak correlations of 0.2-0.4. Considering this data incomparability across methods, we still observed high adherence rates of 78%-98% across measures.ConclusionOur findings contribute to the growing body of knowledge on the impact that methodological aspects exert on the results of adherence measurement in breast cancer patients receiving endocrine treatment. Our findings suggest that the development and validation of instruments specific to patients receiving endocrine agents is imperative in order to arrive at a more accurate assessment and to subsequently obtain more precise estimates of adherence rates in this patient population.

Towards the Implementation of Quality of Life Monitoring in Daily Clinical Routine: Methodological Issues and Clinical Implication

Quality of life (QOL) has become a widely used outcome parameter in the evaluation of treatment modalities in clinical oncology research. By now, many of the practical problems associated with measuring QOL in clinical practice can be overcome by the use of computer-based assessment methods. QOL assessment in oncology is dominated by two measurement systems, the FACT scales and the EORTC QLQ-C30 with its modules. The amount of human resources required to implement routine data collection has been reduced significantly by advanced computer technology allowing data collection in busy clinical practice. Monitoring of QOL can contribute to oncologic care by facilitating detection of physical and psychological problems and tracking the course of disease and treatment over time. Furthermore, the integration of screening for psychosocial problems into QOL monitoring contributes to the identification of patients who are in need of psychooncologic interventions. Computer-based QOL monitoring does not replace the direct physician-patient communication but enables to identify specific impairments and symptoms including psychological problems. Beyond clinical practice, QOL data can be used for research purposes and may help health care planners to determine those patient services that should be maintained or ones that should be developed.

The EORTC emotional functioning computerized adaptive test: phases I-III of a cross-cultural item bank development

The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group is currently developing computerized adaptive testing measures for the Quality of Life Questionnaire Core‐30 (QLQ‐C30) scales. The work presented here describes the development of an EORTC item bank for emotional functioning (EF), which is one of the core domains of the QLQ‐C30.

Following patient pathways to psycho‐oncological treatment: Identification of treatment needs by clinical staff and electronic screening

In this retrospective investigation of patient pathways to psycho‐oncological treatment (POT), we compared the number of POT referrals before and after implementation of electronic screening for POT needs and investigated psychosocial predictors for POT wish at a nuclear medicine department.

Getting the Whole Picture: Adding Patient-reported Outcomes to Adjuvant Endocrine Treatment Evaluation in Premenopausal Breast Cancer Patients

To the Editor: The integration of Patient-Reported Outcomes (PROs) has gained relevance recently within treatment toxicity evaluation. Patient reports have been identified to provide complementary information on treatment toxicity (1,2) compared to proxy-rate based assessments (e.g., CTCAEs) in various cancer populations. This led the FDA and others (3,4) to recommend the utilization of PROs for cancer outcome research and in clinical routine. Looking at the well established, gold standard tamoxifen treatment (TT) for premenopausal, early breast cancer (BC), data on the so called excellent risk-benefit ratio (5) derived from the original admission trials at most lack PROs. At least, some more recent studies indicate a distinct prevalence of side effects originating from treatment induced estrogen suppression such as hot flushes or sexual problems. Understanding risks and benefits of TT from a patient perspective might thereafter be of vital importance for capturing a more precise picture of symptom burden in this patient population. Additionally, symptom burden is known to modulate adherence behavior particularly in patients who consider themselves as cured while experiencing iatrogenic harm. Regarding the considerable nonadherence rates reported in BC patients receiving tamoxifen (6,7) a detailed understanding of the association with TT toxicity might, thus, be essential for health the optimization of care efforts. The objective of our study was first to determine prevalence and severity of patient-reported physical side effects and psychosocial burden in premenopausal, early BC patients receiving upfront TT. Second, the degree of subjectively experienced symptoms compared with data derived from current pivotal trials was investigated. Additionally, the association between patient’s symptom burden and treatment adherence was determined. We conducted a computer-based, cross-sectional PRO-assessment (June 2009–February 2011) including the following instruments: FACT-B/+ES, HADS and the Self-reported measure of medication adherence questionnaire (SMAQ). Symptom frequencies were presented as percentages (95% confidence intervals) and compared with data from the ABCSG-12 trial (5). Ethical approval was provided for the study. The final study sample comprised 156 patients with a median age of 47 years (range 26–59) and a median TT duration of 18.3 months. 58.9% of all patients were fully adherent with regard to accuracy of medication intake according to the SMAQ. Most frequent symptoms were hot flushes (82.8%), sleep disorders (86.0%), and weight gain (39.7; please find details in Table 1). Overall, PROs indicated higher prevalence rates for all symptoms but depression as compared to data derived from the ABCSG-12 trial. Significantly higher PRO-prevalence rates were found for hot flushes, sleeping disorders, breast sensitivity, and fatigue. Symptoms significantly associated with TT adherence were vaginal itching/irritation (RR 1.54; 1.01–2.3), vaginal dryness (RR 1.51; 1.01–2.2), and weight gain (RR 1.78; 1.2–2.6). Vaginal itching or dryness, hence, seemed to increase the probability for nonadherence by about 50%, while weight gain was identified as the strongest associated factor with nonadherence. All other items did not show statistical significance. Our PRO study confirms a notably high level of psychosocial burden and physical side effects in premenopausal BC patients undergoing adjuvant TT. Evidence published only recently seems to support these findings claiming higher frequencies of several Address correspondence and reprint requests to: Georg Goebel, PhD, Department of Medical Statistics, Informatics and Health Economics, Innsbruck Medical University, Schoepfstrasse 41, A-6020 Innsbruck, Austria, or e-mail: georg.goebel@i-med.ac.at Contributed equally.