An international update of the EORTC questionnaire for assessing quality of life in breast cancer patients: EORTC QLQ-BR45.

BACKGROUND: The European Organization for Research and Treatment of Cancer (EORTC) QLQ-BR23 was one of the first disease-specific questionnaires developed in 1996 to assess quality of life (QoL) in patients with breast cancer (BC). However, since 1996 major changes in BC treatment have occurred, requiring an update of the EORTC BC module. This study presents the results of the phase I-III update of the QLQ-BR23 questionnaire. PATIENTS AND METHODS: The update of the EORTC QLQ-BR23 module followed standard EORTC guidelines. A systematic literature review revealed 83 potential relevant QoL issues during phases I and II. After shortening the issues list and following interviews with patients and health care providers, 15 relevant issues were transformed into 27 items. The preliminary module was pretested in an international, multicentre phase III study to identify and solve potential problems with wording comprehensibility and acceptability of the items. Descriptive statistics are provided. Analyses were qualitative and quantitative. We provide a psychometric structure of the items. RESULTS: The phase I and II results indicated the need to supplement the original QLQ-BR23 with additional items related to newer therapeutic options. The phase III study recruited a total of 250 patients (from 12 countries). The final updated phase III module contains a total of 45 items: 23 items from the QLQ-BR23 and 22 new items. The new items contain two multi-item scales: a target symptom scale and a satisfaction scale. The target symptom scale can be divided into three subscales: endocrine therapy, endocrine sexual and skin/mucosa scale. CONCLUSION: Our work has led to the development of a new EORTC QLQ-BR45 module that provides a more accurate and comprehensive assessment of the impact of new and scalable treatments on patients' QoL. The final version of the EORTC QLQ-BR45 is currently available for use in clinical practice. The final phase IV study is underway to confirm psychometric properties of the module.

Promotion of mental health in young adults via mobile phone app: study protocol of the ECoWeB (emotional competence for well-being in Young adults) cohort multiple randomised trials.

BACKGROUND: Promoting well-being and preventing poor mental health in young people is a major global priority. Building emotional competence (EC) skills via a mobile app may be an effective, scalable and acceptable way to do this. However, few large-scale controlled trials have examined the efficacy of mobile apps in promoting mental health in young people; none have tailored the app to individual profiles. METHOD/DESIGN: The Emotional Competence for Well-Being in Young Adults cohort multiple randomised controlled trial (cmRCT) involves a longitudinal prospective cohort to examine well-being, mental health and EC in 16-22 year olds across 12 months. Within the cohort, eligible participants are entered to either the PREVENT trial (if selected EC scores at baseline within worst-performing quartile) or to the PROMOTE trial (if selected EC scores not within worst-performing quartile). In both trials, participants are randomised (i) to continue with usual practice, repeated assessments and a self-monitoring app; (ii) to additionally receive generic cognitive-behavioural therapy self-help in app; (iii) to additionally receive personalised EC self-help in app. In total, 2142 participants aged 16 to 22 years, with no current or past history of major depression, bipolar disorder or psychosis will be recruited across UK, Germany, Spain, and Belgium. Assessments take place at baseline (pre-randomisation), 1, 3 and 12 months post-randomisation. Primary endpoint and outcome for PREVENT is level of depression symptoms on the Patient Health Questionnaire-9 at 3 months; primary endpoint and outcome for PROMOTE is emotional well-being assessed on the Warwick-Edinburgh Mental Wellbeing Scale at 3 months. Depressive symptoms, anxiety, well-being, health-related quality of life, functioning and cost-effectiveness are secondary outcomes. Compliance, adverse events and potentially mediating variables will be carefully monitored. CONCLUSIONS: The trial aims to provide a better understanding of the causal role of learning EC skills using interventions delivered via mobile phone apps with respect to promoting well-being and preventing poor mental health in young people. This knowledge will be used to develop and disseminate innovative evidence-based, feasible, and effective Mobile-health public health strategies for preventing poor mental health and promoting well-being. TRIAL REGISTRATION: ClinicalTrials.gov ( www.clinicaltrials.org ). Number of identification: NCT04148508 November 2019.

Independent psychometric validation of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Endometrial Cancer Module (EORTC QLQ-EN24).

The endometrial cancer (EC)-specific Quality of Life module of the European Organization for Research and Treatment of Cancer (EORTC QLQ-EN24), was developed and validated in one study. We independently validated and assessed the psychometric properties of the instrument. Two hundred and eight women with EC before surgery, during adjuvant treatment and follow-up; in three different cancer centres completed the EORTC QLQ-C30 and the EN24. The questionnaire's completion rate was 100%, except sexuality items, that were answered by 35% of patients. All item-scale correlations for the multi-item scales exceeded the .4 criterion and correlated well with their own scale, while correlations with the other scales were low. The internal consistency of all multi-item scales were satisfactory (Cronbach's alpha coefficients ranging from .77 to .97). Discriminance for single-item scales was low. The QLQ-EN24 module discriminated well between clinically different patients, and there were no differences in quality of life questionnaire scales between patients with body mass index ≤30 when compared to those with >30. This validation study supports the reliability, as well as convergent and divergent validity of the EORTC QLQ-EN24. The module is a useful instrument for the assessment of QOL in patients with EC. However, data concerning sexuality should be interpreted with caution.

Does change in health-related quality of life score predict survival? Analysis of EORTC 08975 lung cancer trial.

BACKGROUND: Little is known about whether changes in health-related quality of life (HRQoL) scores from baseline during treatment also predict survival, which we aim to investigate in this study. METHODS: We analysed data from 391 advanced non-small-cell lung cancer (NSCLC) patients enrolled in the EORTC 08975 study, which compared palliative chemotherapy regimens. HRQoL was assessed at baseline and after each chemotherapy cycle using the EORTC QLQ-C30 and QLQ-LC13. The prognostic significance of HRQoL scores at baseline and their changes over time was assessed with Cox regression, after adjusting for clinical and socio-demographic variables. RESULTS: After controlling for covariates, every 10-point increase in baseline pain and dysphagia was associated with 11% and 12% increased risk of death with hazard ratios (HRs) of 1.11 and 1.12, respectively. Every 10-point improvement of physical function at baseline (HR=0.93) was associated with 7% lower risk of death. Every 10-point increase in pain (HR=1.08) was associated with 8% increased risk of death at cycle 1. Every 10-point increase in social function (HR=0.91) at cycle 2 was associated with 9% lower risk of death. CONCLUSIONS: Our findings suggest that changes in HRQoL scores from baseline during treatment, as measured on subscales of the EORTC QLQ-C30 and QLQ-LC13, are significant prognostic factors for survival.

Validation of the Polish version of the EORTC QLQ-CX24 module for the assessment of health-related quality of life in women with cervical cancer.

The aim of our study was to undertake a prospective validation study of the Polish version of the EORTC cervical cancer (EORTC QLQ-CX24) module used alongside the EORTC core measure. The translated module was pilot-tested according to the established EORTC guidelines. Patients with histological confirmation of cervical cancer were eligible for the study. All patients filled out the Polish version of the EORTC QLQ-CX24 module in addition to EORTC QLQ-C30 and a demographic questionnaire. Standardised validity and reliability analyses were performed. One hundred and seventy-one patients were enrolled into the study, mean age ± SD: 52.1 ± 9.6. Cronbach alpha coefficients, range 0.81-0.88, showed positive internal consistency. Re-test was undertaken with 40 patients (23.4%). Interclass correlations for the EORTC QLQ-CX24 ranged from 0.85 to 0.89 and proved appropriate test-retest reliability. Satisfactory convergent and discriminant validity in multi-trait scaling analyses was seen. Concluding, the Polish version of the EORTC QLQ-CX24 module is a reliable and valid tool for measuring HRQoL in patients with cervical cancer. It can be fully recommended for use in clinical and epidemiological settings in the Polish population.

Minimal clinically meaningful differences for the EORTC QLQ-C30 and EORTC QLQ-BN20 scales in brain cancer patients.

BACKGROUND: We aimed to determine the smallest changes in health-related quality of life (HRQoL) scores in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30 and the Brain Cancer Module (QLQ-BN20), which could be considered as clinically meaningful in brain cancer patients. MATERIALS AND METHODS: World Health Organisation performance status (PS) and mini-mental state examination (MMSE) were used as clinical anchors appropriate to related subscales to determine the minimal clinically important differences (MCIDs) in HRQoL change scores (range 0-100) in the QLQ-C30 and QLQ-BN20. A threshold of 0.2 standard deviation (SD) (small effect) was used to exclude anchor-based MCID estimates considered too small to inform interpretation. RESULTS: Based on PS, our findings support the following integer estimates of the MCID for improvement and deterioration, respectively: physical (6, 9), role (14, 12), and cognitive functioning (8, 8); global health status (7, 4*), fatigue (12, 9), and motor dysfunction (4*, 5). Anchoring with MMSE, cognitive functioning MCID estimates for improvement and deterioration were (11, 2*) and for communication deficit were (9, 7). Estimates with asterisks were <0.2 SD and were excluded from our MCID range of 5-14. CONCLUSION: These estimates can help clinicians evaluate changes in HRQoL over time, assess the value of a health care intervention and can be useful in determining sample sizes in designing future clinical trials.

Emotion Regulation as a Mediator in the Relationship Between Cognitive Biases and Depressive Symptoms in Depressed, At-risk and Healthy Children and Adolescents.

Contemporary cognitive models of depression propose that cognitive biases for negative information at the level of attention (attention biases; AB) and interpretation (interpretation biases; IB) increase depression risk by promoting maladaptive emotion regulation (ER). So far, empirical support testing interactions between these variables is restricted to non-clinical and clinical adult samples. The aim of the current study was to extend these findings to a sample of children and adolescents. This cross-sectional study included 109 children aged 9-14 years who completed behavioural measures of AB (passive-viewing task) and IB (scrambled sentences task) as well as self-report measures of ER and depressive symptoms. In order to maximize the variance in these outcomes we included participants with a clinical diagnosis of depression as well as non-depressed youth with an elevated familial risk of depression and non-depressed youth with a low familial risk of depression. Path model analysis indicated that all variables (AB, IB, adaptive and maladaptive ER) had a direct effect on depressive symptoms. IB and AB also had significant indirect effects on depressive symptoms via maladaptive and adaptive ER. These findings provide initial support for the role of ER as a mediator between cognitive biases and depressive symptoms and provide the foundations for future experimental and longitudinal studies. In contrast to studies in adult samples, both adaptive as well as maladaptive ER mediated the effect of cognitive biases on depressive symptoms. This suggests potentially developmental differences in the role of ER across the lifespan.

Development of neural correlates of empathy from childhood to early adulthood: an fMRI study in boys and adult men.

Although empathy is rooted early in life, the ability to understand and share the emotions of others continues to develop after childhood. Here, we aimed at exploring developmental changes in the neural mechanisms underlying empathy from childhood to early adulthood. Using functional magnetic resonance imaging, 47 healthy male subjects aged 8-27 years were investigated during an explicit empathy task. Emotional faces were presented and participants were either asked to infer the emotional state from the face (other-task) or to judge their own emotional response to the face (self-task). A perceptual decision on the width of faces was used as a control condition. Age-related activity increases were observed in the fusiform gyrus and inferior frontal gyrus, depending on whether subjects attributed emotions to self or other. During the self-task, activity in the right precuneus and right intraparietal sulcus decreased as a function of age. No age-related differences were observed in behavioral performance measures. Increased activity in the fusiform gyrus and in the frontal component of the human mirror neuron system with increasing age may be explained by greater experience and expertise accumulated during socio-emotional interactions. Greater recruitment of right parietal structures in younger as compared to older subjects might reflect developmental differences in the cognitive strategies to infer one's own emotional response. This study is the first to show developmental changes in the neural mechanisms supporting empathy. Our findings may have important implications for the development of novel therapeutic interventions in clinical conditions characterized by empathy deficits, such as autism spectrum disorder.

The role of attentional deployment during distancing in adolescents with major depression.

Individuals with major depression (MD) show deficits in cognitive reappraisal. It is yet unexplored how the act of directing visual attention away from/towards emotional aspects impacts on cognitive reappraisal in MD. Thus, we examined the role of attentional deployment during cognitive reappraisal (specifially during distancing) in adolescent MD. 36 MD adolescents and 37 healthy controls (12-18 years) performed a cognitive reappraisal task during which they a) down-regulated self-reported negative affective responses to negative pictures via distancing, or b) simply attended to the pictures. During the task, attentional focus was systematically varied by directing participants' gaze to emotional vs. non-emotional picture aspects. The validity of this experimental manipulation was checked by continuous eye-tracking during the task. Across groups and gaze focus conditions, distancing diminished negative affective responses to the pictures. Regulation success significantly differed between groups dependent on gaze focus: MD adolescents showed relatively less regulation success than controls in the emotional gaze focus condition, while the reverse was true for the non-emotional gaze focus condition. The results suggest that in MD adolescents, an emotional context might interfere with emotion regulatory aims. The findings can provide an important starting point for the development of innovative training regimes that target deficient reappraisal processes in adolescents suffering from MD.

Altered neural processing of reward and punishment in adolescents with Major Depressive Disorder.

BACKGROUND: Altered reward and punishment function has been suggested as an important vulnerability factor for the development of Major Depressive Disorder (MDD). Prior ERP studies found evidence for neurophysiological dysfunctions in reinforcement processes in adults with MDD. To date, only few ERP studies have examined the neural underpinnings of reinforcement processing in adolescents diagnosed with MDD. The present event-related potential (ERP) study aimed to investigate neurophysiological mechanisms of anticipation and consumption of reward and punishment in adolescents with MDD in one comprehensive paradigm. METHOD: During ERP recording, 25 adolescents with MDD and 29 healthy controls (12-17 years) completed a Monetary Incentive Delay Task comprising both a monetary reward and a monetary punishment condition. During anticipation, the cue-P3 signaling attentional allocation was recorded. During consumption, the feedback-P3 and Reward Positivity (RewP) were recorded to capture attentional allocation and outcome evaluation, respectively. RESULTS: Compared to controls, adolescents with MDD showed prolonged cue-P3 latencies to reward cues. Furthermore, unlike controls, adolescents with MDD displayed shorter feedback-P3 latencies in the reward versus punishment condition. RewPs did not differ between groups. LIMITATIONS: It remains unanswered whether the observed alterations in adolescent MDD represent a state or trait. CONCLUSIONS: Delayed neural processing of reward cues corresponds to the clinical presentation of adolescent MDD with reduced motivational tendencies to obtain rewards. Relatively shorter feedback-P3 latencies in the reward versus punishment condition could indicate a high salience of performance-contingent reward. Frequent exposure of negatively biased adolescents with MDD to performance-contingent rewards might constitute a promising intervention approach.

Health related quality of life outcomes in cancer clinical trials.

Over the last decade, health related quality of life (HRQOL) investigations have become an increasingly important part of many cancer clinical trial research programs. This paper presents a review of all HRQOL studies published by the European Organisation for Research and Treatment of Cancer (EORTC), one of the largest clinical trials organisations in Europe. The findings highlight 24 clinical trials that have been published to date, enrolling over 9000 patients. HRQOL is fully integrated into EORTC phase III trials. In many trials, HRQOL provides a valuable source of additional information useful to both clinician and patient when making treatment decisions. Furthermore, several trials have found that the combined use of clinical information along with HRQOL data has led to the development of new standards of care in several different cancer sites. With more than 40 ongoing HRQOL studies in the EORTC, we expect HRQOL to play an even greater role over the coming decade in helping establish the optimal treatment and care approach for cancer patients.

Auditory selective attention in adolescents with major depression: An event-related potential study.

BACKGROUND: Major depression (MD) is associated with deficits in selective attention. Previous studies in adults with MD using event-related potentials (ERPs) reported abnormalities in the neurophysiological correlates of auditory selective attention. However, it is yet unclear whether these findings can be generalized to MD in adolescence. Thus, the aim of the present ERP study was to explore the neural mechanisms of auditory selective attention in adolescents with MD. METHODS: 24 male and female unmedicated adolescents with MD and 21 control subjects were included in the study. ERPs were collected during an auditory oddball paradigm. RESULTS: Depressive adolescents tended to show a longer N100 latency to target and non-target tones. Moreover, MD subjects showed a prolonged latency of the P200 component to targets. Across groups, longer P200 latency was associated with a decreased tendency of disinhibited behavior as assessed by a behavioral questionnaire. LIMITATIONS: To be able to draw more precise conclusions about differences between the neural bases of selective attention in adolescents vs. adults with MD, future studies should include both age groups and apply the same experimental setting across all subjects. CONCLUSIONS: The study provides strong support for abnormalities in the neurophysiolgical bases of selective attention in adolecents with MD at early stages of auditory information processing. Absent group differences in later ERP components reflecting voluntary attentional processes stand in contrast to results reported in adults with MD and may suggest that adolescents with MD possess mechanisms to compensate for abnormalities in the early stages of selective attention.

Development of a European Organization for Research and Treatment of Cancer questionnaire module to assess the quality of life of ovarian cancer patients in clinical trials: a progress report.

A questionnaire was developed, according to the European Organization for Research and Treatment of Cancer (EORTC) published guidelines, to supplement the EORTC quality of life questionnaire-core 30 (QLQ-C30) to assess the quality of life (QL) of women with ovarian cancer treated in clinical trials. The provisional 28-item module, OV28, assesses abdominal symptoms; peripheral neuropathy; other chemotherapy side-effects; hormonal symptoms; body image; attitude to disease and treatment; and sexual functioning. The first 24 items of the module (excluding sexual functioning) were included in a UK multicentre trial (SCOTROC). The trial data were used for preliminary scaling analysis. Two problematic items were identified. When these were treated as single items along with the 'other chemotherapy side-effects' the instrument showed excellent scale properties. Mean scale scores discriminated between trial patients pre- and on chemotherapy. This is a promising tool for assessing the QL of women with ovarian cancer. The EORTC international field study (Protocol 15982) to assess more fully the psychometric properties of the OV28 is well underway.

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.

Quality of life evaluation in oncological clinical trials - the EORTC model. The EORTC Quality of Life Study Group.

The European Organization for Research and Treatment of Cancer (EORTC) has taken a leading role in the development of the methodology of quality of life (QL) measurement. In the EORTC Quality of Life Study Group (QLSG) valid instruments to assess QL in a general manner and disease-specific modules have been developed to be used in oncological clinical trials. Statistical and methodological aspects of QL research are discussed. The application of QL assessments in clinical trials represents a subsequent challenge. To improve the practice of QL assessment in clinical trials an 'EORTC model' has been developed. This model requires the collaboration of liaison persons, the EORTC Cooperative Tumour Groups and the EORTC Data Centre Quality of Life Unit (QL Unit). Cooperation between these parties, protocol development and advantages and concerns of the model are mentioned in this paper. Finally, suggestions for improvement are proposed.

Functioning in daily living and psychological well-being of female cancer patients.

The objective of this prospective study was to compare outcomes concerning psychological and physical functioning of patients with various gynecological malignancies. A sample of 119 newly diagnosed cancer patients completed two questionnaires evaluating psychological well-being and functioning in daily living. Outcome measures were obtained at three time points: before surgery, 3 months after surgery, and 1 year after surgery. The results showed that the psychological well-being improved significantly from the first to the third time point for the sample as a whole. After surgery, patients with ovarian and cervical cancer showed slightly lower scores than patients with endometrial cancer. The level of functioning in daily living declined 3 months after surgery for all except endometrial cancer patients, but increased significantly at the 1 year follow-up. At all three time points the mean differences for psychological well-being and functioning in daily living were not statistically significant among subgroups. Physical and psychological well-being of the patients treated for gynecological malignancies is affected independently of age, cancer site and stage of disease. However, throughout the observational period the psychological well-being scores were lower than those of patients with other chronic illnesses or healthy subjects. Therefore, we conclude that psychological interventions for patients facing gynecological cancer treatment should be provided as an integral component of cancer management.

Women's sexual behavior, body image and satisfaction with surgical outcomes after hysterectomy: a comparison of vaginal and abdominal surgery.

The aim of this study was to investigate the impact of vaginal and abdominal hysterectomy on women's sexual behavior, sexual dysfunction, body image and satisfaction with surgery. A prospective study was conducted on 90 women to evaluate the outcomes of hysterectomy. Data were collected prior to surgery, three months and two years after surgery, using self-report questionnaires. The results showed significant differences in women's sexual behavior and sexual dysfunction before and after hysterectomy, independent of the surgical procedure performed. Women in both groups reported improvements in sexual desire, sexual activity and sexual intercourse three months and two years after surgery. Sexual dysfunction such as dyspareunia, vaginismus, lack of orgasm and loss of sexual interest diminished significantly after surgery. Regression analyses revealed that postmenopausal status, severity of gynecological complaints and frequency of sexual intercourse were the most important factors for improved sexual outcomes. Women in the abdominal group were dissatisfied with their body image because of the abdominal scar, experienced more pain and had a longer period of recovery from surgery compared to women in the vaginal group. According to the results, sexual behavior alone is not an important factor in choosing vaginal or abdominal hysterectomy. However, sexual behavior was important in both groups when evaluating outcomes after hysterectomy.

Increasing women's knowledge and satisfaction with cervical cancer screening.

In a randomized clinical trial, the efficacy of three interventions, designed to increase patient knowledge of cancer screening and satisfaction with preventive health care, were evaluated: verbal information; graphically supported information; information provided using video colposcopy; no standardized information (control condition). A sample of 147 healthy women were randomly assigned to the intervention group (IG) or the control group (CG). Pre- and post-test measures were obtained using a semi-structured interview, the State-Trait Anxiety Inventory and the Patient Satisfaction Tool. At pre-test, women had a low level of knowledge which increased significantly at post-test. The knowledge scores were slightly higher in women who received information supported by graphic or video colposcopy than in women who received standardized information without teaching aids. Compared to the CG, women in the IGs scored significantly higher on questions related to cervical cancer prevention. The level of satisfaction was significantly higher in women receiving video-supported information and graphic-supported information compared to women receiving information without teaching aids. The results indicated that visual teaching aids were effective: video colposcopy in increasing patient satisfaction with preventive health care; and graphic representation in improving knowledge regarding cancer screening. The combination of both should routinely accompany cervical cancer screening.

[Importance of locus of control in the disease adjustment process in women with genital cancer]. / Die Bedeutung von Kontrollüberzeugungen im Krankheitsverarbeitungsprozess bei Frauen mit Genitalkarzinomen.

This study deals with psychological aspects of coping observed in gynecological cancer patients--on the one hand with behavioral, emotional and cognitive reactions to the disease and on the other hand with the efficiency value of these mechanisms in handling the disease. As one important aspect, the attitude towards control of the disease should be correlated with the coping process. Accordingly, the results demonstrate a correlation between high self-responsibility and positive appraisal of the disease: Women who believe they are in control of the disease try harder to fight the disease and interpret their own situation more positively than women with a fatalistic attitude and this enables them to make more sense of the disease; they experience more positive changes in their own lifestyle due to the disease. Furthermore, women who ascribe responsibility for the course of the disease to other interpret their situation in a more positive light. They actively search for social support and obviously experience this trust in the power of other people as a helpful measure. A fatalistic attitude to the disease is combined with rumination and social withdrawal.