Bernhard Holzner

Comparison of Two Quality-of-Life Instruments for Cancer Patients: The Functional Assessment of Cancer Therapy-General and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30

PURPOSE To compare two quality-of-life (QOL) questionnaires for cancer patients, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) and the Functional Assessment of Cancer Therapy-General (Fact-G), on the basis of empirical data. PATIENTS AND METHODS Two hundred forty-four patients with a diagnosis of breast cancer or Hodgkins disease completed both the EORTC QLQ-C30 and the FACT-G (German language version) during the same session. Questionnaire data were analyzed on a subscale basis using correlation analysis, canonical correlation, and multiple linear regression. RESULTS Correlations between corresponding subscales of the FACT-G and the EORTC QLQ-C30 ranged from r =.14 for the social domain (very poor agreement) to r =.66 for the physical domain (good agreement), with r values for the other domains lying between these extremes. Canonical correlation analysis for the two sets of subscales revealed that overall agreement between the two instruments was only moderate (first canonical correlation coefficient r =.85, but overall redundancy less than 40%). Of the five FACT-G subscales, only one, physical well-being, was well represented by the EORTC QLQ-C30 subscales (multiple linear regression, R(2) =.67). Only three of eight EORTC QLQ-C30 subscales (physical functioning, global QOL, general symptoms) were represented fairly well by FACT-G subscales (R(2) =.43 to.60). The lowest R(2) values (<.15; ie, virtually no representation by the other instrument) were found for the FACT-G social well-being and relation with doctors and EORTC QLQ-C30 cognitive functioning subscales. CONCLUSION For the sample investigated, the EORTC QLQ-C30 and the FACT-G were found to measure markedly different aspects of QOL, despite considerable overlap. Replicability provided, this implies that neither of the two QOL instruments can be replaced by the other and that a direct comparison of results obtained with the two instruments is not possible.

Long-term improvements in cognitive performance through computer-assisted cognitive training: A pilot study in a residential home for older people

The aim of the present pilot study was to investigate the effects of computer-assisted cognitive training on aging-associated memory deficits, information processing speed, learning, and interference tendency in older people. Residents of a home for older people (15 women, four men; mean age 83.5; range 75-91) participated in a 14-week computer-assisted cognitive training program. The Nürnberg Aging Inventory and the California Verbal Learning Test were administered prior to the program, immediately after the program and after a period of five months to assess the effectiveness of the cognitive training. After the cognitive training program there were significant improvements in primary working memory and also secondary working memory (for verbal and visual stimuli), on parameters of information processing speed, learning and interference tendency. Improvements in the last two cognitive parameters were maintained five months after completion of the training program. The present study indicates that computerized cognitive training programs can be used in older people to achieve long-term improvements in some important aspects of fluid intelligence. It is suggested that computers could be employed more extensively to prevent and treat cognitive deficits in older people.

Use of alternative / complementary therapy in breast cancer patients – a psychological perspective

Abstract. The objectives of this study were to assess the additional use of alternative (complementary) therapies in patients with breast cancer who were receiving conventional treatment and to compare patients using alternative therapies with patients receiving only conventional treatment with special reference to psychological adaptation, causal attribution and quality of life. A sample of 117 female out-patients with a diagnosis of breast cancer filled in the following assessment instruments: FQCI (Freiburg Questionnaire for Coping with Illness), PUK (Causal Attribution Questionnaire), EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire), POMS (Profile of Mood States), and a self-developed questionnaire on alternative therapies. Nearly half the patients (47%, n=55) reported that they had used alternative therapies in addition to conventional treatment. The methods applied most frequently were nutrition-related measures (special drinks, vitamin preparations and wholefoods – each applied by about 50% of users), mistletoe preparations (49%), trace elements (47%), and homeopathy (31%). Compared with patients receiving only conventional treatment, the users of alternative therapy were younger and better educated. Users developed a more active style of illness coping than non-users and showed more religious involvement. Patients using a large number of alternative therapies (>3) tended to adopt a more depressive coping style than those using only a small number (≤3). For a substantial proportion of cancer patients alternative therapies apparently fulfil an important psychological need. However, a subgroup of patients using many alternative therapies seem to have considerable adjustment problems. In dealing with cancer patients the treatment team should be aware of both these groups.

EORTC QLQ‐C30 and FACT‐BMT for the measurement of quality of life in bone marrow transplant recipients: a comparison

Abstract: The purpose of the study was to compare two differentquality‐of‐life self‐rating instruments, namely the EORTC QLQ‐C30, developed by the quality‐of‐life study group of the European Organisation for Research and Treatment of Cancer, and the FACT‐BMT (version 3), the Functional Assessment of Cancer Therapy – Bone Marrow Transplantation scale, which is the FACT‐G(eneral measure) in combination with a module developed specifically for evaluating quality of life of bone marrow transplant (BMT) patients. Fifty‐six BMT recipients completed both the EORTC QLQ‐C30 and the FACT‐BMT (German language version) during the same session. Questionnaire data were analyzed on a subscale basis using correlation analysis and multiple linear regression. Correlations between corresponding subscales of EORTC QLQ‐C30 and the FACT‐BMT ranged from r=0.30 for the emotional domain (poor agreement) to r=0.77 for global QOL (good agreement). This suggests that the instruments, despite considerable overlap, possibly focus on different aspects of QOL, in particular in addressing emotional and social issues of BMT patients. It appears that the FACT‐BMT gives a more comprehensive overview regarding the multidimensional construct of quality of life. The EORTC QLQ‐C30 gives more insight into the physical aspects of quality of life and helps to identify symptoms which effectively decrease quality of life from the patients perspective. The QLQ‐C30 might be improved by the incorporation of a BMT‐specific module currently under development. We therefore conclude that neither of the two instruments can be replaced by the other in the assessment of QOL of BMT patients and that a direct comparison of results obtained with the two instruments is likely to be misleading.

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.

Taste Alterations in Cancer Patients Receiving Chemotherapy: A Neglected Side Effect?

BACKGROUND Taste alterations (TAs) are a frequent but under-recognized treatment side effect in cancer patients undergoing chemotherapy (CT). CT regimens with different toxicity profiles may vary in their impact on TAs, but research on this topic is lacking. This study assesses the prevalence of TAs and their relation to sociodemographic and clinical variables, especially CT regimens. Furthermore, the association between TAs and quality of life (QOL) is investigated. PATIENTS AND METHODS TAs and QOL data were collected longitudinally in 197 cancer patients (lung cancer, 54.3%; pancreatic cancer, 19.3%; colorectal cancer, 26.4%; age, 65.2 +/-10.4 years; male, 57.4%) who were receiving CT at the Department of Internal Medicine at Kufstein County Hospital, giving rise to a total of 1,024 assessment times. Patients completed the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire and two additional questions taken from the EORTC item bank concerning TAs. Statistical analyses were performed using mixed-effect models. RESULTS The study showed that the prevalence of TAs in chemotherapy patients is alarmingly high (69.9%). There were clear differences in TA scores among treatment groups: patients receiving irinotecan reported significantly more TAs than patients in other treatment groups; patients receiving a combination of gemcitabine and a platinum agent reported the lowest TAs. Additionally, significant associations between TAs and several QOL dimensions were found, especially with appetite loss and fatigue. CONCLUSION The high prevalence of TAs and their impact on QOL in CT patients underscore the urgent need for increased attention to this side effect, both in research and in clinical practice.

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).

Health-related quality of life assessment and reported outcomes in leukaemia randomised controlled trials – A systematic review to evaluate the added value in supporting clinical decision making

Health-related quality of life (HRQOL) is increasingly reported as an important outcome in cancer clinical trials. However, very little evidence exists on the impact of such evaluation in randomised controlled trials (RCTs) of leukaemia patients. A systematic search of the literature from 1980 to 2007 was undertaken and studies were identified and evaluated independently, according to a pre-defined coding scheme, by three reviewers. Both HRQOL outcomes and traditional clinical reported outcomes were systematically analysed to evaluate their consistency and their relevance for supporting clinical decision making. Nine RCTs were identified, involving 3838 patients overall. There were four RCTs involving acute myeloid leukaemia patients (AML), three with chronic myeloid leukaemia (CML) and two with chronic lymphocytic leukaemia (CLL). Six studies were published after 2000 and provided fairly robust methodological quality. Imatinib greatly improved HRQOL compared to interferon based treatments in CML patients and fludarabine plus cyclophosphamide does not seem to have a deleterious impact on patients HRQOL when compared to fludarabine alone or chlorambucil in CLL patients. This study revealed the paucity of HRQOL research in leukaemia patients. Nonetheless, HRQOL assessment is feasible in RCTs and has the great potential of providing valuable outcomes to further support clinical decision making.

Quality of life measurement in oncology—a matter of the assessment instrument?

Two widely used quality of life questionnaires, European Organization for Research and Treatment of Cancer Core (EORTC QLQ-C30) & Functional Assessment of Cancer Therapy-General (FACT-G), were examined for their comparability using four different groups of cancer patients. During a follow-up investigation, 418 cancer patients (Hodgkins disease, breast cancer, bone marrow transplantation (BMT), chronic lymphatic leukaemia (CLL)) completed both the EORTC QLC-C30 and the FACT-G during the same session. For an illustration of the differences between the two Quality of Life (QoL) instruments, pairs of diagnostic groups were formed and their QoL scores using the EORTC QLQ-C30 and FACT-G compared. The corresponding subscales of the EORTC-QLC-C30 and the FACT-G show only low to moderate intercorrelations across all four groups of cancer patients studied. In particular, a comparison of pairs, namely Hodgkins disease versus breast cancer patients and BMT versus CLL patients, highlights substantial differences in the corresponding subscales of the EORTC QLQ-C30 and the FACT-G. The results of the QoL investigations should not be interpreted independently of the instrument used and an interpretation of results must be based on the contents of items of the respective questionnaires.

The Computer-based Health Evaluation Software (CHES): a software for electronic patient-reported outcome monitoring

BackgroundPatient-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.MethodsFollowing 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.ResultsBy 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.DiscussionDuring 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.