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Purpose: Alopecia has been reported a distressing side-effect of chemotherapy for breast cancer patients (BCP) that is highly relevant for quality of life during treatment. For the prevention of chemotherapy-induced alopecia, scalp cooling (SC) has been reported to be an effective and safe intervention. However, data on the patient's perspective on effectiveness and applicability of SC in a clinical routine setting are scarce. In this comparative study, we aimed at a longitudinal assessment of patient-reported outcome (PRO) data on the effect of SC on alopecia and its effect on symptoms and functional health when applied in clinical routine in BCP receiving taxane or anthracycline-based chemotherapy.Patients and Methods: Study participants were allocated either to the intervention group receiving SC or to the control group based on patient preference (non-randomized study). All patients completed PRO-measures on hair preservation (EORTC Item Library items on hair loss), symptom and functional health measures (EORTC QLQ-C30 and -BR23) and the Body Image Scale (BIS). Outcomes were assessed at chemotherapy start (baseline), mid-chemotherapy, last chemotherapy cycle, 3 months follow-up and 6– 9 months follow-up.Results: Overall, we included 113 patients: 75 patients underwent SC (mean age = 51.3 years, 52.7% premenopausal); 38 patients standard care (mean age = 55.6 years, 39.5% premenopausal). A total of 53 patients (70.7%) discontinued SC, with 39 patients (73.5%) stating alopecia as the primary reason. On average, BCP stayed on treatment with the cooling cap for 40.2% of the duration of their chemotherapy (SD 25.3%). In an intention-to-treat analysis, we found no difference between the SC group and the control group with regard to their patient-reported hair loss (p=0.831) across the observation period, overall QOL (p=0.627), emotional functioning (p=0.737), social functioning (p=0.635) and body image (p=0.463) did not differ between groups.Conclusion: We found a high rate of SC-decliners and no beneficial effects of SC for patient-reported hair loss, symptoms and functional health. The efficacy and tolerability of SC applied in a clinical routine setting hence appeared to be limited. The further determination and up-front definition of criteria prognostic for effectiveness of SC may be helpful to identify patient subgroups that may experience a treatment benefit. [ABSTRACT FROM AUTHOR]

Abstract Background Patient-reported Outcomes (PROs) capturing e.g., quality of life, fatigue, depression, medication side-effects or disease symptoms, have become important outcome parameters in medical research and daily clinical practice. Electronic PRO data capture (ePRO) with software packages to administer questionnaires, storing data, and presenting results has facilitated PRO assessment in hospital settings. Compared to conventional paper-pencil versions of PRO instruments, ePRO is more economical with regard to staff resources and time, and allows immediate presentation of results to the medical staff. The objective of our project was to develop software (CHES – Computer-based Health Evaluation System) for ePRO in hospital settings and at home with a special focus on the presentation of individual patient’s results. Methods Following the Extreme Programming development approach architecture was not fixed up-front, but was done in close, continuous collaboration with software end users (medical staff, researchers and patients) to meet their specific demands. Developed features include sophisticated, longitudinal charts linking patients’ PRO data to clinical characteristics and to PRO scores from reference populations, a web-interface for questionnaire administration, and a tool for convenient creating and editing of questionnaires. Results By 2012 CHES has been implemented at various institutions in Austria, Germany, Switzerland, and the UK and about 5000 patients participated in ePRO (with around 15000 assessments in total). Data entry is done by the patients themselves via tablet PCs with a study nurse or an intern approaching patients and supervising questionnaire completion. Discussion During the last decade several software packages for ePRO have emerged for different purposes. Whereas commercial products are available primarily for ePRO in clinical trials, academic projects have focused on data collection and presentation in daily clinical practice and on extending cancer registries with PRO data. CHES includes several features facilitating the use of PRO data for individualized medical decision making. With its web-interface it allows ePRO also when patients are home. Thus, it provides complete monitoring of patients‘physical and psychosocial symptom burden.

Abstract Background Current 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. Methods Outpatients 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. Results Comparison 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. Conclusion Our 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.

Abstract Introduction Within an ongoing project of the EORTC Quality of Life Group, we are developing computerized adaptive test (CAT) measures for the QLQ-C30 scales. These new CAT measures are conceptualised to reflect the same constructs as the QLQ-C30 scales. Accordingly, the Fatigue-CAT is intended to capture physical and general fatigue. Methods The EORTC approach to CAT development comprises four phases (literature search, operationalisation, pre-testing, and field testing). Phases I-III are described in detail in this paper. A literature search for fatigue items was performed in major medical databases. After refinement through several expert panels, the remaining items were used as the basis for adapting items and/or formulating new items fitting the EORTC item style. To obtain feedback from patients with cancer, these English items were translated into Danish, French, German, and Spanish and tested in the respective countries. Results Based on the literature search a list containing 588 items was generated. After a comprehensive item selection procedure focusing on content, redundancy, item clarity and item difficulty a list of 44 fatigue items was generated. Patient interviews (n = 52) resulted in 12 revisions of wording and translations. Discussion The item list developed in phases I-III will be further investigated within a field-testing phase (IV) to examine psychometric characteristics and to fit an item response theory model. The Fatigue CAT based on this item bank will provide scores that are backward-compatible to the original QLQ-C30 fatigue scale.

Objectives: Vulva cancer (VC) treatment carries a high risk of severe late effects that may have a negative impact on quality of life (QoL). Patient-reported outcome measures (PROMs) are increasingly used when evaluating disease- and treatment-specific effects. However, the adequacy of measures used to assess sequelae and QoL in VC remains unclear. The aims of the present study were to evaluate disease- and treatment-related effects as measured by PROMs in VC patients and to identify available VC-specific PROMs. Methods/Materials: A systematic literature search from 1990 to 2016 was performed. The inclusion criterion was report of disease- and treatment-related effects in VC patients using PROMs in the assessment. Methodological and reporting quality was in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. This systematic review was performed as part of phase 1 of the development of a European Organisation for Research and Treatment of Cancer QoL questionnaire for VC patients. Results: The search revealed 2299 relevant hits, with 11 articles extracted including a total of 535 women with VC; no randomized controlled trials were identified. The selected studies exhibited great heterogeneity in terms of PROMs use. Twenty-one different instruments assessed QoL. Most of the questionnaires were generic. Different issues (sexuality, lymphedema, body image, urinary and bowel function, vulva-specific symptoms) were reported as potentially important, but the results were not systematically collected. Only one VC-specific questionnaire was identified but did not allow for assessment and reporting on a scale level. Conclusions: Vulva cancer treatment is associated with considerable morbidity deteriorating QoL. To date, there is no validated PROM available that provides adequate coverage of VC-related issues. The study confirms the need for a VC-specific QoL instrument with sensitive scales that allows for broad cross-cultural application for use in clinical trials. [ABSTRACT FROM AUTHOR]

Abstract: To develop and pretest an European Organization for the Research and Treatment of Cancer Sexual Health Questionnaire (EORTC SHQ‐22) for the assessment of physical, psychological, and social aspects of sexual health (SH) in male and female cancer patients and survivors. Questionnaire construction started with creating a list of relevant SH issues based on a comprehensive literature review. Issues were subsequently evaluated for relevance and prioritization by 78 healthcare professionals (HCP) and 107 patients from 12 countries during in‐depth interviews (phase 1). Extracted issues were operationalized into items (phase 2). Phase 3 focused on pretesting the preliminary questionnaire in a cross‐cultural patient sample (n = 171) using debriefing interviews. Psychometric properties were preliminary determined using a principal component analysis and Cronbach's alpha. We derived 53 relevant SH issues from the literature. Based on HCP and patient interviews, 22 of these 53 issues were selected and operationalized into items. Testing the preliminary 22‐item short questionnaire resulted in a change of wording in five items and two communication‐related items; no items were removed. Preliminary psychometric analysis revealed a two‐factor solution and 11 single items; both scales showed good reliability indicated by a Cronbach's alpha of 0.87 (sexual satisfaction) and 0.82 (sexual pain). Cross‐cultural pretesting of the preliminary EORTC SH questionnaire has indicated excellent applicability, patient acceptance, and comprehensiveness as well as good psychometric properties. The final development phase, that is psychometric validation (phase four) including large‐scale, cross‐cultural field testing of the EORTC SHQ‐22, has commenced. [ABSTRACT FROM AUTHOR]

Background: Cancer survivorship is of increasing importance in post-treatment care. Sexual health (SH) and femininity can be crucial issues for women surviving cancer. We aimed to determine a more complete understanding of the contribution that a breast cancer (BC) diagnosis and its treatment exert on patients' follow-up SH. For this purpose, self-reported levels and predictors of SH in breast cancer survivors (BCS) were compared with those of women with no previous or current BC (WNBC).Methods: BCS and WNBC underwent a comprehensive, cross-sectional patient-reported outcome (PRO) assessment. Validated PRO instruments were used to measure SH, body image, anxiety and depression and menopausal symptoms. Assessments were performed within the routine clinical setting. Instruments used were the Sexual Interest and Desire Inventory - Female, Sexual Activity Questionnaire, Body Image Scale, Hospital Anxiety and Depression Scale and the Menopause-Specific Quality of Life Questionnaire.Results: One hundred five BCS (average time since diagnosis of 3 years) and 97 WNBC with a mean age of 49 years completed the assessment. SH was significantly worse in BCS compared to WNBC (p = 0.005; BCS SIDI-F mean = 24.9 vs. WNBC mean = 29.8). 68.8% of BCS and 58.8% of WNBC met criteria of a hypo-active sexual desire disorder. Higher depressive symptoms, higher age and lower partnership satisfaction were predictive for poorer SH in BCS.Conclusion: SH problems are apparent in BCS and differ significantly from those seen in the general population. Consequently, BC survivorship care should include interventions to ameliorate sexual dysfunction and provide help with depressive symptoms and partnership problems, which are associated with poor BCS SH. [ABSTRACT FROM AUTHOR]

Background: Role functioning (RF) as a core construct of health-related quality of life (HRQOL) comprises aspects of occupational and social roles relevant for patients in all treatment phases as well as for survivors. The objective of the current study was to improve its assessment by developing a computer-adaptive test (CAT) for RF. This was part of a larger project whose objective is to develop a CAT version of the EORTC QLQ-C30 which is one of the most widely used HRQOL instruments in oncology.Methods: In accordance with EORTC guidelines, the development of the RF-CAT comprised four phases. Phase I involved the conceptualization of RF. In Phase II, a provisional list of items was defined and revised by experts in the field. In phase III, feedback was obtained from cancer patients in various countries. Phase IV comprised field testing in an international sample, calibration of the item bank, and evaluation of the psychometric performance of the RF-CAT.Results: Phases I-III yielded a list of 12 items eligible for phase IV field-testing. The field-testing sample included 1,023 patients from Austria, Denmark, Italy, and the UK. Psychometric evaluation and item response theory analyses yielded 10 items with good psychometric properties. The resulting item bank exhibits excellent reliability (mean reliability = 0.85, median = 0.95). Using the RF-CAT may allow sample size savings from 11 % up to 50 % compared to using the QLQ-C30 RF scale.Conclusions: The RF-CAT item bank improves the precision and efficiency with which RF can be assessed, promoting its integration into oncology research and clinical practice. [ABSTRACT FROM AUTHOR]

Background: In chemotherapy trials quality of life (QOL) is assessed mostly at the days of chemotherapy administration (i.e. event-driven) during treatment and follows fixed time intervals in the aftercare phase (i.e. time-driven). Specific QOL impairments and treatment side-effects are known to be time dependent following different trajectories. Therefore, acute problems are likely to be missed if assessments are done infrequently or at inappropriate time points. Since the planning of supportive care interventions during chemotherapy depends on knowledge about symptom trajectories, such information may be of substantial importance to a clinician. Methods: Cancer patients receiving chemotherapy at Kufstein County Hospital were assessed using an electronic version of the EORTC QLQ-C30 at the day of chemotherapy administration at the hospital. One and two weeks later assessments were repeated via the internet while patients were at home. Assessments at home and the hospital were conducted using the web-based software CHES. Data were analysed by means of linear mixed models. Results: A sample of 54 chemotherapy outpatients participated in electronic QOL assessments at the hospital and at home. For 9 out of the 15 QOL domains of the EORTC QLQ-C30 patients reported increased burden one week after chemotherapy administration compared to the day of chemotherapy administration. Most pronounced differences were found for Fatigue, Constipation, and Appetite Loss. Conclusions: Our results indicate that patients experience most severe QOL impairments in the week following chemotherapy administration. This is a period that is usually not covered by QOL assessments in chemotherapy trials which may result in underestimation of true treatment burden. Our findings suggest to conduct QOL assessments not only event- or time-driven, but to rely on specific hypotheses on symptom and functioning trajectories. [ABSTRACT FROM AUTHOR]

Background. Taste alterations (TAs) are frequently reported by chemotherapy patients. However, research on this topic is very scarce. The etiologies of TAs are not fully known and prevalences may vary across tumour types and chemotherapy regimens. The aim of the present study was to longitudinally investigate TAs in patients with breast cancer or gynaecological cancers receiving chemotherapy, and to provide expected values for TAs for these patient populations. Patients and methods. One hundred and nine cancer patients (32.1% gynaecological cancer, 67.9% breast cancer) receiving chemotherapy at the Department for Internal Medicine of Kufstein County Hospital were consecutively included in the study. At each visit the Quality of Life Questionnaire-Core30 and a screening scale for TAs, consisting of two validated questions taken from the European Organisation for Research and Treatment of Cancer item bank was administered. Statistical analysis was performed using mixed-effect models. Results. The prevalence of TAs in breast cancer and gynaecological cancer patients receiving chemotherapy was high (76.1%). There were differences in the extent of TAs as well as in their time course across treatment groups. The lowest TAs were found in breast cancer and gynaecological cancer patients treated with gemcitabine. The highest TAs were found in breast cancer patients treated with epirubicin/docetaxel/capecitabine. The steepest increase of TAs was found in patients treated with epirubicin/docetaxel. Moreover, significant associations between TAs and appetite loss as well as fatigue were found. Conclusion. The results show that TAs are an issue in breast and gynaecological cancer patients receiving different chemotherapy regimens. There is a need for a more systematic investigation of TAs in chemotherapy patients in general as well as the need to address this issue in clinical practice. [ABSTRACT FROM AUTHOR]

Introduction: Due to the high mortality of cancer a large number of patients pass a preterminal phase of their illness. Within this phase medical care aims at maintaining patients' quality of life (QOL) and reducing symptom burden. Our study investigated the patient-reported severity of QOL impairments during the last year of life, with a special focus on their course at the end of life. Methods: All patients with cancer receiving palliative care at Natters State Hospital (Austria) were considered as eligible for the study. QOL data were collected with the EORTC QLQ-C30 questionnaire as part of computerized patient-reported outcome monitoring (ePROM) within clinical routine. QOL was investigated longitudinally in regard to its course toward death as well as to changes in determinants of global QOL. Results: Eighty-five patients participated in the ePROM (255 assessments in total). Regarding trajectories, physical, role and cognitive functioning, fatigue and global QOL worsened sharply during the last 3 months of life. A steady decline was found for emotional functioning, pain, appetite loss and taste alterations. The impact of role functioning, sleep disturbances, and taste alterations on global QOL increased within the last 3 months of life. Conclusion: Our results indicate that most aspects of QOL are considerably impaired in patients with advanced cancer. Furthermore, they highlight the importance of assessing QOL in general and taste alterations in particular within palliative care. [ABSTRACT FROM AUTHOR]

The application of cytochrome P450 2D6 (CYP2D6) genotyping to allow a personalized treatment approach for breast cancer patients undergoing endocrine therapy has been repeatedly discussed. However, the actual clinical relevance of the CYP2D6 genotype in the endocrine treatment of breast cancer still remains to be elucidated. A major prerequisite for the successful and valid evaluation of the CYP2D6 genotype with regard to its pharmacokinetic and clinical relevance is the availability of a comprehensive, accurate and cost-effective CYP2D6 genotyping strategy. Herein we present a CYP2D6 genotyping assay employing polymerase chain reaction (PCR)-ion pair reversed-phase high-performance liquid chromatography-electrospray ionization time-of-flight mass spectrometry (ICEMS). The genotyping strategy involves the simultaneous amplification of nine variable regions within the CYP2D6 gene by a two-step PCR protocol and the direct analysis of the generated PCR amplicons by ICEMS. The nucleotide composition profiles generated by ICEMS enable the differentiation of 37 of the 80 reported CYP2D6 alleles. The assay was applied to type the CYP2D6 gene in 199 Austrian individuals including 106 breast cancer patients undergoing tamoxifen treatment. The developed method turned out to be a highly applicable, robust and cost-effective approach, enabling an economical CYP2D6 testing for large patient cohorts. [ABSTRACT FROM AUTHOR]

Introduction: Within an ongoing project of the EORTC Quality of Life Group, we are developing computerized adaptive test (CAT) measures for the QLQ-C30 scales. These new CAT measures are conceptualised to reflect the same constructs as the QLQ-C30 scales. Accordingly, the Fatigue-CAT is intended to capture physical and general fatigue. Methods: The EORTC approach to CAT development comprises four phases (literature search, operationalisation, pre-testing, and field testing). Phases I-III are described in detail in this paper. A literature search for fatigue items was performed in major medical databases. After refinement through several expert panels, the remaining items were used as the basis for adapting items and/or formulating new items fitting the EORTC item style. To obtain feedback from patients with cancer, these English items were translated into Danish, French, German, and Spanish and tested in the respective countries. Results: Based on the literature search a list containing 588 items was generated. After a comprehensive item selection procedure focusing on content, redundancy, item clarity and item difficulty a list of 44 fatigue items was generated. Patient interviews (n = 52) resulted in 12 revisions of wording and translations. Discussion: The item list developed in phases I-III will be further investigated within a field-testing phase (IV) to examine psychometric characteristics and to fit an item response theory model. The Fatigue CAT based on this item bank will provide scores that are backward-compatible to the original QLQ-C30 fatigue scale. [ABSTRACT FROM AUTHOR]

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. Copyright © 2009 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]