Ann Cull

The European organization for research and treatment of cancer approach to developing questionnaire modules: an update and overview

The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Study Group has adopted a modular approach to quality of life (QoL) assessment in cancer clinical trials. The core instrument (the EORTC QLQ-C30) covers a range of QoL issues relevant to a broad spectrum of patients with cancer. The QLQ-C30 is designed to be supplemented by more specific subscales (‘modules’) to assess aspects of QoL of particular importance to specific subgroups of patients. Since individual members of the study group were to be involved in module development, guidelines were established. The primary aim of these guidelines was to standardize the module development process in order to ensure uniformly high quality across modules. This paper gives an update of the work completed to date. First, while the guidelines proved practical for module development, producing modules that exhibit adequate levels of psychometric and cross-cultural validity, experience pointed to three areas where the guidelines required more precision. These amendments will be provided and include (1) stricter monitoring of the developmental process from within the study group, (2) the explicit requirement of involvement of the study group and (3) a more precise definition of the criteria to be fulfilled before modules are allowed to be called ‘EORTC modules’. Second, an overview of the modules currently under development or available for general use is provided. These modules include those for body image, high-dose chemotherapy, leukaemia, myeloma, palliative care and the following cancers: bladder, brain, breast, colorectal, head and neck, lung, oesophageal, ophthalmic, ovarian, pancreas and prostate. Finally, the need for the coordination of efforts in module development, both from within and outside the EORTC, is discussed.

Pain relief and quality of life following radiotherapy for bone metastases: a randomised trial of two fractionation schedules

BACKGROUND The optimum dose and fractionation schedule for the palliative irradiation of painful bone metastases is controversial. PURPOSE To compare the efficacy, side-effects and effect on quality of life of two commonly used radiotherapy schedules in the management of painful bone metastases. MATERIALS AND METHODS In a prospective trial, 280 patients were randomised to receive either a single 10 Gy treatment or a course of 22.5 Gy in five daily fractions for the relief of localised metastatic bone pain. RESULTS Response rates have been calculated from 240 assessable treated sites of pain. The overall response rates were 83.7% (single treatment) and 89.2% (five fractions). The complete response rates were 38.8% (single treatment) and 42.3% (five fractions). The median duration of pain control was 13.5 weeks (single treatment) and 14.0 weeks (five fractions). None of these differences was statistically significant. There were no differences between the groups in the effect of treatment on a variety of quality of life parameters. CONCLUSIONS It is concluded that a single 10 Gy treatment is as effective as a course of 22.5 Gy in five fractions in the management of painful bone metastases.

Major depression in outpatients attending a regional cancer centre: screening and unmet treatment needs

A screening programme designed to identify cases of Major Depressive Disorder (MDD) in patients attending a Regional Cancer Centre outpatient department was established. It comprised two stages: (1) The Hospital Anxiety and Depression Scale (HADS) self-rating questionnaire administered by a touch-screen computer; (2) we interviewed patients with high scores on the HADS (15 or more total score) over the telephone using the depression section of the Structured Clinical Interview for DSMIV (SCID). A large consecutive sample (5613) of oncology clinic attenders was screened, and practical difficulties in the screening process were identified. The estimated prevalence of major depressive disorder (MDD) in the sample surveyed was approximately 8% (7.8%; 95% confidence intervals 6.9–8.5%). We assessed a consecutive series of 150 patients identified as having MDD to determine how many had received evidence-based treatment for MDD. Only half had discussed their low mood with their general practitioner, only one-third had been prescribed any antidepressant medication, and very few had taken a therapeutic dose for an adequate period. Very few had received psychological treatment or had been referred to mental health services. Most were receiving no potentially effective therapy.

The impact of genetic counselling about breast cancer risk on women’s risk perceptions and levels of distress

SummaryWomen referred to a familial breast cancer clinic completed questionnaires before and after counselling and at annual follow-up to assess their risk estimate and psychological characteristics. The aims were to determine whether those who attended the clinic overestimated their risk or were highly anxious and whether counselling influenced risk estimates and levels of distress. Women (n = 450) at this clinic were more likely to underestimate (39%) than overestimate (14%) their risk. Mean trait anxiety scores were higher than general population data (t = 4.9, n = 1059, P < 0.001) but not significantly different from published data from other screening samples. Overestimators (z = 5.69, P < 0.0001) and underestimators (z = –8.01, P < 0.0001) reported significantly different risk estimates (i.e. increased accuracy) after counselling, but significant inaccuracies persisted. Over- (n = 12) and underestimators (n = 60) were still inaccurate in their risk estimates by a factor of 2 after counselling. Thirty per cent of the sample scored above the cut-off (5/6) for case identification on a screening measure for psychological distress, the General Health Questionnaire (GHQ). GHQ scores were significantly lower after counselling (t = 3.6, d.f. = 384, P = 0.0004) with no evidence of increasing risk estimate causing increased distress. The risk of distress after counselling was greater for younger women and those who were more distressed at first presentation. The counselling offered was effective in increasing the accuracy of risk perceptions without causing distress to those who initially underestimated their risk. It is worrying that inaccuracies persisted, particularly as the demand for service has since reduced the consultation time offered in this clinic. Further work is needed to evaluate alternative models of service delivery using more sophisticated methods of assessing understanding of risk.

Factor analysis of the Hospital Anxiety and Depression Scale from a large cancer population

The Hospital Anxiety and Depression Scale (HADS) is widely used as a tool for assessing psychological distress in patients and non-clinical groups. Previous studies have demonstrated conflicting results regarding the factor structure of the questionnaire for different groups of patients, and the general population. This study investigated the factor structure of the HADS in a large heterogeneous cancer population of 1474 patients. It also sought to investigate emerging evidence that the HADS conforms to the tripartite model of anxiety and depression (Clark & Watson, 1993), and to test the proposal that detection rates for clinical cases of anxiety and depression could be enhanced by partialling out the effects of higher order factors from the HADS (Dunbar et al., 2000). The results demonstrated a two-factor structure corresponding to the Anxiety and Depression subscales of the questionnaire. The factor structure remained stable for different subgroups of the sample, for males and females, as well as for different age groups, and a subgroup of metastatic cancer patients. The two factors were highly correlated (r =.52) and subsequent secondary factor analyses demonstrated a single higher order factor corresponding to psychological distress or negative affectivity. We concluded that the HADS comprises two factors corresponding to anhedonia and autonomic anxiety, which share a common variance with a primary factor namely psychological distress, and that the subscales of the HADS, rather than the residual scores (e.g. Dunbar et al., 2000) were more effective at detecting clinical cases of anxiety and depression.

Job stress and satisfaction among palliative physicians

A national questionnaire-based survey has found that palliative physicians report lower levels of burnout and similar levels of psychiatric morbidity than those reported by consultants in other specialties. To try to explain these findings, this study compared the sources of job stress and satisfaction reported by consultant palliative physicians with those reported by consultants working in four other specialties: surgery, gastroenterology, radiology and oncology. Stressful and satisfying aspects of work were assessed using questionnaires designed specifically for the study. The response rate for the palliative physicians was 126/154 (82%) and for the consultants in the other specialties 882/1133 (78%). Palliative physicians reported that feeling overloaded and its effect on home life made the greatest contribution to their job stress, and having good relationships with patients, relatives and staff made the greatest contribution to their job satisfaction. However, compared with the other specialist groups, palliative physicians reported less stress from overload (p < 0.001) and more satisfaction from having good relationships (p < 0.001). They also reported less stress and more satisfaction with the way they are managed and resourced (both p < 0.001). Hospital-based palliative physicians reported more stress and less satisfaction from their management and resources than their colleagues working in hospices (both p = 0.05). Thirty-five percent of palliative physicians felt insufficiently trained in communication skills and 81% felt insufficiently trained in management skills. Burnout was more prevalent among consultants who felt insufficiently trained in communication and management skills than among those who felt sufficiently trained. It is important therefore that effective training in communication and management skills are provided and that, at the very least, existing levels of resourcing and management practices within palliative medicine are maintained in order that physicians working in the specialty are able to provide care to dying patients without prejudicing their own mental health.

Feasibility and Compliance of Automated Measurement of Quality of Life in Oncology Practice

PURPOSE Systematic quality-of-life (QOL) assessment may have value in oncology practice by increasing awareness of a wide range of issues, possibly increasing detection of psychologic morbidity, social problems, and changes in physical status, and improving care and its outcomes. However, logistic problems are substantial. Automated systems solve many of these problems. We field-tested the feasibility and compliance that can be achieved using a computer touchscreen system in two consecutive studies. PATIENTS AND METHODS In study 1, a prospective cohort of 272 patients was offered QOL assessment at each clinic appointment for 6 months. In study 2, all patients (N = 1,291) were offered QOL assessment as part of clinic routine during a 12-week period. RESULTS In study 1, 82% of patients agreed to take part, but over time, compliance was poor (median, 40%; mean, 43%) and deteriorated with longer follow-up. In study 2, the overall compliance was greatly increased (median, 100%; mean, 70%), and compliance was retained over multiple visits. In study 1, compliance was better in younger patients, males, and socially advantaged patients, but was not affected by the presence of depression or anxiety, or QOL. In the second study, building on experience in the first study, data collection and storage in the computer system was excellent, achieving 98% of collected data stored in one center. In general, patients were comfortable with the computers and the approach. Data collection on the wards was more difficult and less complete than in clinics, especially for patients undergoing acute admissions. CONCLUSION Feasibility with higher compliance was demonstrated in study 2, in which the data collection was integrated into routine care, and can be improved with further technical initiatives and education of staff.

An international field study of the reliability and validity of a disease-specific questionnaire module (the QLQ-OV28) in assessing the quality of life of patients with ovarian cancer

This study defines the psychometric properties of the European Organisation for Research and Treatment of Cancer (EORTC) quality of life (QOL) questionnaire designed to measure the QOL of patients with ovarian cancer. The ovarian cancer module (EORTC QLQ-OV28) was developed to supplement the EORTC QLQ-C30. The core questionnaire and the QLQ-OV28 were prospectively administered to 368 ovarian cancer patients after they had been treated with radical or debulking surgery followed by chemotherapy. The QLQ-OV28 module assesses abdominal/gastrointestinal symptoms, peripheral neuropathy, other chemotherapy side-effects, hormonal/menopausal symptoms, body image, attitude to disease/treatment and sexual functioning. Questionnaires were well accepted by patients, baseline compliance rates were 86%, 72% provided a second assessment, less than 3% of the items had missing data. Multi-trait scaling analyses confirmed the hypothesised scales. All hypothesised scales exhibited good psychometric properties. These results support the clinical and psychometric validity of the EORTC QLQ-OV28 module as a supplement to the EORTC QLQ-C30.

Neuropsychometric evaluation of long-term survivors of adult brain tumours: relationship with tumour and treatment parameters

BACKGROUND Cognitive deficits are the hallmark of dose limiting late radiation morbidity in the CNS. Little is known about the neuropsychometric morbidity of treatment in adults with primary brain tumours. We set out to evaluate systematically the neuropsychometric function of all long-term survivors in order to document the frequency and severity of impairment and study its relationship with tumour and treatment related parameters. MATERIALS AND METHODS 30 patients surviving in clinical and radiological remission for > 4 years following irradiation were recalled for clinical examination, CT/MRI scan and neuropsychometric testing. The 14 males, 16 females, (mean age 42.5 years), represented all but one long term survivors treated with radiotherapy in the Department of Clinical Oncology between 1971 and 1990. Twenty-five patients had a histological diagnosis of glioma. Patients treated before 1987 (n = 16) received whole brain irradiation (WBI); focused irradiation (FI) has been used since (n = 14). RESULTS The two groups were similar were in age, initial tumour type and surgical treatment, but the WBI group showed more evidence of neuropsychometric impairment than the FI group with significantly lower group median scores in tests of visuospatial organisation (WAIS Block Design, P = 0.01), visual memory (Rey Complex figure, P = 0.003) and complex information processing (Trails A, P = 0.003; Trails B, P = 0.002). Pre-morbid IQ estimated from sociodemographic variables, was comparable in the 2 groups which were not significantly different in their emotional state as assessed by the HADS. On univariate analysis radiation volume (P = 0.05) and time from treatment (P = 0.02) were the main factors associated with neuropsychometric deficit. Multivariate analysis by logistic regression confirmed WBI as the only independent predictor of neuropsychometric impairment (WBI vs. FI, odds ratio = 7.1, 95% C.I. 1.2-42.3, P = 0.03). CONCLUSIONS Neuropsychometric deficits are common and can be related to time from treatment and radiation technique. Neuropsychometric testing can be a useful tool in the evaluation of different treatment strategies.

A family history of breast cancer: women's experiences from a theoretical perspective

Individuals at increased risk of developing breast cancer due to their family history of the disease face a number of uncertainties. Personal cancer risk estimates are imprecise and current methods for early detection or prevention are not 100% effective. It is therefore not surprising that adverse psychosocial outcomes have been described within this population. Research attempting to predict the incidence of distress and dysfunction in individuals at increased risk of cancer has been largely a-theoretical and has overlooked a number of potentially important predictive variables. In particular, the influence of personal experience of cancer through involvement with affected relatives has been neglected. There are strong theoretical grounds for hypothesising that dimensions of personal experience may influence response to cancer risk. This paper discusses the potential impact of personal experience on risk perception, illness representations and decision-making. Systematic research in this area may improve predictions of outcome of cancer genetic counselling and inform the clinical process.