Breast cancer advocacy across Europe through the work and development of EUROPA DONNA, the European Breast Cancer Coalition.
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Breast Neoplasms↗
Biomedical subjects
P Mosconi
Publications and source records attributed to P Mosconi.
The SF-36 instrument for the follow-up of health-related quality-of-life assessment of patients undergoing home parenteral nutrition for benign disease.
INTRODUCTION: The non-disease-specific SF-36 instrument was applied to detect changes in quality of life among patients at a single center who were receiving home parenteral nutrition (HPN) for intestinal failure. METHODS: All HPN patients completed the questionnaire during routine visits. The SF-36 examines eight domains (scores: 0% to 100%): physical functioning (PF), role-functioning physical (RP), body pain (BP), general health (GH), vitality (VT), social functioning (SF), as well as role-functioning emotional (RE) and mental health (MH). Patient responses were standardized for the sex- and age-matched group scores of the healthy population by calculating the Z-score: (healthy population mean score - patient raw score)/healthy population standard deviation (reduced value: Z-score < -1). A difference in a domain score was considered significant in the individual patient if it was greater than the 90% confidence interval for healthy subjects and if it produced a change in Z-score category. General, sociodemographic, underlying disease and HPN-related factors were collected. RESULTS: For 31 enrolled adult patients, the baseline mean Z-score was reduced in five domains: PF, RP, BP, GH and SF. Twenty patients underwent a second SF-36 assessment 10 +/- 2 months later: the HRQOL worsened in eight and improved in 10 (no. worsened domains > no. improved or vice versa). The worsened subgroup showed a decrease in body mass index (P =.104), an increase in the number of HPN infusions per week (P =.065), and a greater incidence of intestinal motility disorders (P =.161), of liquid oral diet (P =.027), and of nycturia (P =.028). CONCLUSIONS: The SF-36 instrument reflecting the generic HRQOL assessment may be a suitable tool for patients on HPN.
Adolescent↗
Cisplatin versus carboplatin in combination with mitomycin and vinblastine in advanced non small cell lung cancer. A multicenter, randomized phase III trial.
BACKGROUND: In advanced not selected NSCLC chemotherapy achieved an advantage of approximately 1-2 months on median survival versus best supportive care. Chemotherapy seems to improve symptoms control, even if randomised studies with quality of life as first endpoint are lacking and often chemotherapy toxicity compromises the frail cost/benefit ratio. The aim of the present study is to evaluate the impact on QoL, substituting cisplatin, a pivot drug in NSCLC therapy, with carboplatin, an analogue with an improved toxicity profile. The combination of cisplatin with Mitomycin and Vinblastine was one of the most frequently used in the palliative setting at the time of design of our study. METHODS: Patients were randomized to receive MVP regimen (Mitomycin-C 8 mg/m2 d1, Vinblastine 4 mg/m2 d 1-8, Cisplatin 100 mg/m2 d1) or MVC regimen (Mitomycin-C 8 mg/m2 d1, Vinblastine 4 mg/m2 d 1-8, Carboplatin 300 mg/m2 d1) every 3 weeks. The QoL was evaluated by the Spitzer QL-Index and by the EORTC QLQ-C30+LC 13 questionnaires before chemotherapy, after one cycle, after three cycles, and then every 6 weeks in the first 6 months and every 3 months thenafter. RESULTS: From September 1994 to July 1997, 153 consecutive patients were randomized to MVP (75 patients) or MVC arm (78 patients). Despite difficulties in carrying out and analysing QoL items in such patients, the global QoL evaluated by the Spitzer's questionnaire suggested an advantage for MVC regimen (P=0.05) and a significant difference was observed in global health subdomain (P=0.04). The disease-related symptoms improved with time, and the benefits lasted for the entire treatment period. When evaluated with the EORTC questionnaire there was significantly less nausea and vomiting (P=0.0001), appetite loss (P=0.01), insomnia (P=0.03), constipation (P=0.01) and peripheral neuropathy (P=0.01) in favour of MVC, and a trend for less hair loss (P=0.05). The advantage lasted for all the duration of chemotherapy. No differences were observed in global quality of life subdomain (P=0.40) between the two regimen. QoL was the first endpoint and the statistical power was inadequate to assess other parameters. However, we reported a response rate of 43.1 and 38.6%, respectively, in MVP and MVC arm (P=0.59) and a median survival of 10.2 and 7.2 months, respectively, for cisplatin and carboplatin arm (P=0.39). CONCLUSIONS: The carboplatin containing regimen (MVC) has a significant better toxicity profile than the cisplatin containing (MVP) regimen as proven both by the EORTC questionnaires and by the WHO toxicity data reported by physicians. No significant differences in terms of response rate, time to progression and overall survival were observed between the two regimen. The two chemotherapy regimen showed a similar effectiveness in symptom palliation when evaluated with C30 addendum of EORTC QOL questionnaire. With the Spitzer's questionnaires a trend towards an improved quality of life index was observed during treatment with the carboplatin combination in comparison to the cisplatin combination. This difference, however, was not observed when the global quality of life was evaluated with the EORTC patients compiled questionnaires. A carboplatin containing regimen with better toxicity profile and a similar potentiality for symptoms control offers an option in comparison to similar cisplatin containing combinations in the palliative treatment of advanced NSCLC.
Aged↗
EUROPA DONNA: has strength in its heterogeneity.
EUROPA DONNA, a non-profit-making organisation, is a pan-European movement against breast cancer; it is a coalition that is active in 29 countries, each organised into national independent Fora. In each Forum, a postal survey was conducted between 2001 and 2002. A standardised questionnaire was used to collect information about Forum characteristics and activities, and perceptions of the adequacy of the local health service in relation to the prevention, diagnosis and treatment of breast cancer. Twenty-seven Fora (93%) participated in the survey. The results show the heterogeneity between the Fora in the services offered and activities in the different countries. The Fora also perceived a range of deficiencies in the prevention, diagnosis and treatment of breast cancer within their national health systems. These results highlight the importance of a coalition to establish a consensus among the Fora, and the need for coordinated initiatives in different European countries.
Breast Neoplasms↗
Genetic testing and breast cancer: the women's point of view.
Breast cancer is the most common cancer among women in Western countries (130,000 cases per year in Europe) and accounts for 20-25% of all malignancies in European women. In the past few years medical journals have focused greater attention on the quality and quantity of information provided to consumers; there is a general consensus amongst physicians on the importance of having better informed consumers. This change in attitude is influencing greatly the physician-patient relationship and political decisions. Breast cancer associations, like the National Breast Cancer Coalition in the USA or EUROPA DONNA, the European Breast Cancer Coalition in Europe, have pushed for involvement in the discussion of any phase of illness, and have a particular interest in preventive medicine. The identification of high-risk women by genetic testing for BRCA1 and BRCA2 mutations is largely debated, in particular regarding patient counseling, and psychosocial and legislative support. This article reports the different points of view raised by women's movements, so that useful suggestions may be provided to improve breast cancer prevention modalities.
BRCA1 Protein↗
Oncologists' opinion of ethics committees functioning in Italy.
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Attitude of Health Personnel↗
The Migraine Disability Assessment (MIDAS) questionnaire: translation and reliability of the Italian version.
We have developed and tested an Italian version of the Migraine Disability Assessment (MIDAS) questionnaire, an established instrument for assessing headache-related disability. A multistep process was used to translate and adapt the questionnaire into Italian, which was then tested on 109 Italian migraine without aura patients, 86 (78.9%) of whom completed the form a second time 21 days later. Overall MIDAS score had good test-retest reliability (Spearman's correlation 0.77), closely similar to that found in English-speaking migraineurs, and individual responses were also satisfactorily reliable. Internal consistency was good (Cronbach's alpha 0.7). These findings support the use of the MIDAS questionnaire as a clinical and research tool with Italian patients.
Adult↗
Subjective health status assessment: evaluation of the Italian version of the SF-12 Health Survey. Results from the MiOS Project.
BACKGROUND: SF-12 is a generic short form health survey, developed in the USA from the original SF-36. It produces two summary measures evaluating physical and mental self-perceived health that are interchangeable with those from the SF-36. SF-12 has been successfully tested in nine Western European countries on large samples of the general population, where it has proved its brevity, comprehensiveness, reliability, validity and cross-cultural applicability. The present analysis directly assesses the SF-12 for the first time in various Italian settings, including the general population and specific patient groups. METHODS: Data for this report were collected from five different samples; in four of them the SF-12 was used as a 'stand-alone' instrument, while in the other one (used as the reference) it was embedded in the SF-36. Descriptive statistics, Spearman's correlation coefficients, confirmatory factor analysis, ordinal uni- and multi-variate least squares regression model and covariance analysis were used to evaluate the summary measures in each sample, and across relevant subgroups. Studies were ordered according to the expected deviance, from the 'normal' health status of the reference group to the sample with the expected highest level of illness. RESULTS: Overall, more than 11,000 subjects were evaluated. Response rates ranged from 63 to 100%, while missing items accounted only for 0.2-8.2% of all items. Uni- and multi-variate analyses showed a positive association between both physical component summary (PCS) and mental component summary (MCS) scores and their respective items in all examined samples. MCS scores were fairly similar across all samples, with the only exception being patients recently discharged from hospital, whose subjective mental health perception was higher than expected and the highest of all (52.2). Finally, we found a substantial impact of ageing on physical health perception, while the MCS was shown to be less sensitive to the age effect. CONCLUSIONS: This analysis shows that the SF-12 has good validity, while some issues related to its most appropriate mode of administration and target groups might require further attention.
Adolescent↗
Survival, quality of life and breast cancer.
In recent years, evaluating quality of life (QoL) has become increasingly important as an additional measured outcome in cancer clinical trials, in particular in the field of breast cancer. This paper, after a general introduction to the present debate on the methodological issues involved in QoL evaluation, reviews results and open questions regarding the use of this measure in surgical, adjuvant and metastatic studies.
Breast Neoplasms↗
The performance of SF-36 health survey in patients with laryngeal cancer. Head and Neck Cancer Italian Working Group.
BACKGROUND: Interest in measuring health-related quality of life has increased together with the awareness that such humanistic outcomes require valid and reliable measures. Among the several generic questionnaires, the Short Form 36 Items Health Survey (SF-36) is recognized for its comprehensiveness, brevity, and high standards of reliability and validity. It has been translated and validated in several languages. METHODS: In the framework of a larger, prospective, multicenter study aimed to produce and validate an Italian questionnaire tailored to laryngeal cancer patients, the SF-36 was administered to a sample of well-characterized cases. It was, therefore, possible to test its characteristics in terms of patients' acceptance, psychometric, and clinical validity. RESULTS: Overall, findings show that in this sample of 165 consecutive patients with laryngeal cancer at various stage of disease, the SF-36 performance was very good. The patients' acceptance was satisfactory: all patients completed the questionnaire. All the questionnaire scales met the standards suggested in terms of grouping and scaling assumptions. The internal reliability coefficients actually replicate the satisfactory findings reported for the original SF-36. In terms of capability of the questionnaire scales to discriminate between groups expected to differ in a given health concept in relation to clinical variables, the results were also good. CONCLUSIONS: This study showed that SF-36 was well accepted by patients and was able to detect the impact of different treatment approaches on health- related quality of life. It is likely that the sensitivity and the precision of the SF-36 can be further improved by integrating brief questionnaire modules specific for laryngeal clinical issues.
Adaptation, Psychological↗
Patients are important links in the healthcare chain.
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Breast Implants↗
Quality of life in women with recurrent breast cancer.
Although the psychosocial concomitants of early-stage breast cancer have been well-documented, the relationship between cancer recurrence and quality of life remains less clear. We conducted a prospective, longitudinal study in order to clarify the relationship between recurrent cancer and quality of life, and to determine predictors of quality of life following recurrence. Sixty-nine women with recurrent breast cancer completed questionnaires assessing multiple components of quality of life at three time points: prior to recurrence, immediately after the diagnosis of recurrence, and at follow-up 6 months later. Perceptions of overall quality of life, general health status, emotional, social, and physical functioning were poorer immediately following the diagnosis of recurrence than they had been prior to recurrence. These women also evidenced significant improvement in several domains of quality of life between initial recurrence and follow-up; nonetheless, most areas of quality of life were impaired compared to pre-recurrence. Self-reported physical symptoms were a strong predictor of post-recurrence ratings of overall quality of life. These data suggest that the recurrence of breast cancer is associated with significant changes in quality of life. Quality of life did not progressively deteriorate, however, attesting to the resilience of women coping with this major stressor. These data shed light on issues of potential importance to patients managing this serious illness and may have implications for health-care professionals working with this population.
Aged↗
Health-related quality of life in dialysis patients. A report from an Italian study using the SF-36 Health Survey. DIA-QOL Group.
BACKGROUND: Interest in measuring health-related quality of life (HRQoL) has increased together with an awareness that such humanistic outcomes require valid and reliable measures. In the last decade short, simple and multidimensional generic and disease-specific questionnaires have been developed. Among the several generic questionnaires available, the Short Form 36 Items Health Survey (SF-36) was translated and validated in several languages, and applied to different settings and diseases. METHODS: Within the framework of a larger, prospective, multicentre study (DIA-QOL project) the SF-36 was administered to 304 patients to test its characteristics in terms of patient acceptability, and psychometric and clinical validity. Standard psychometric techniques were used to evaluate its validity in terms of convergence, divergence and internal consistency reliability (Cronbach's alpha). Correlations between clinical variables and HRQoL scores were performed to test the questionnaire's capability to capture differences across patients groups. RESULTS: Overall, the findings show that, in this sample, the SF-36's performance was very good. Acceptability was satisfactory, with a response rate higher than 80%. All the questionnaire scales met the psychometric standards suggested in terms of grouping and scaling assumptions. The internal reliability coefficients actually replicate the satisfactory findings reported previously for the original SF-36. In terms of the ability of the questionnaire scales to discriminate between groups expected to differ in a given health concept in relation to clinical variables, the results were also good. On average, females reported lower scores, the impact of ageing was more evident for physical scales. Diabetic patients score significantly worse on the physical function scale and patients with mental health problems score significantly lower on the mental health scale. No significant association was found with the index KtV, haemoglobin levels, body mass index, parathyroid hormone and type of dialysis. A strong association was indeed found between SF-36 scales measuring physical health concepts and the serum albumin level. This association held after adjusting for the confounding effect of age. Comparison of the health profile of the present sample with others from the US and UK and from a representative sample of the Italian general population highlights the potential of such questionnaire in dialysis setting. CONCLUSIONS: The SF-36 questionnaire is easy to use in Italian dialysis patients and SF-36 scores are related to important clinical aspects. This approach can help in caring for dialysis patients and can be useful in outcome assessment programmes.
Adult↗
Validation of Italian multiple sclerosis quality of life 54 questionnaire.
OBJECTIVES: Health related quality of life (HRQOL) inventories are multi-dimensional measures of patient-centred health status developed for clinical research. The MS quality of life 54 (MSQOL-54) is an MS-specific HRQOL inventory originally devised for English speaking patients. It consists of a core measure, the 36-item short form health survey (SF-36) previously adapted into Italian, and 18 additional items exploring domains relevant to patients with MS (MS-18 module). The authors translated and culturally adapted into Italian the MS-18 module of the MSQOL-54 questionnaire, and clinically validated the whole questionnaire. METHODS: The MS-18 module was translated following the methodology of the International Quality of Life Assessment (IQOLA) project. The MSQOL-54 was validated in 204 consecutive patients with MS seen between April and September 1997 at three participating centres. The questionnaire was explained by the physician who also administered the expanded disability status scale (EDSS) and mini mental status scale examination, and the patient filled in the MSQOL-54 and Beck depression inventory questionnaires (BDI), with assistance if required. The contribution of impairments and disabilities to MSQOL-54 scores were assessed, and mean scores were compared with normative data for the general Italian population, and with the original sample of United States MS patients. RESULTS: The mean age of the 204 patients was 42 years; mean EDSS score was 4.5 (range 0-8. 5). Patients' participation in the assessment was satisfactory, and all scales satisfied the usual psychometric standards. The characteristics of the United States sample matched those of our patients in all but gender (72% United States patients v 52% Italian patients were women), and education (90% United States patients and 44% Italian patients completed high school); MSQOL-54 profiles were also similar. The EDSS was significantly associated with the physical health composite but not with the mental health composite score. Multiple linear regression modelling showed that age and BDI independently predicted physical health composite (p < 0.001), and mental health composite (p < 0.001). Clinical worsening in the previous year had an independent effect on the physical health composite (p < 0.001). CONCLUSIONS: The Italian version of MSQOL-54 is easy to administer and is well accepted by patients. Neurological impairment has a limited influence on perceived quality of life, while age and depressive symptoms has a major influence.
Adult↗
GIVIO-SITAC 01: A randomized trial of adjuvant 5-fluorouracil and folinic acid administered to patients with colon carcinoma--long term results and evaluation of the indicators of health-related quality of life. Gruppo Italiano Valutazione Interventi in Oncologia. Studio Italiano Terapia Adiuvante Colon.
BACKGROUND: In 1989, the authors began a randomized trial to determine whether 5-fluorouracil and high dose folinic acid (HD-FUFA) would increase the event free and overall survival of patients with resectable Dukes B and C (AJCC/UICC Stage II and Stage III) colon carcinoma, and to assess the toxicity of the treatment and its impact on selected health-related quality-of-life indicators. Early results were published as a part of an international multicenter pooled analysis (IMPACT) in 1995. The purpose of this report is to update the survival data for patients enrolled in the trial and describe their reported perceptions of their own health and quality of life. METHODS: The trial involved multiple treatment centers, with a centralized randomization between surgery alone and surgery with chemotherapy. The HD-FUFA regimen employed consisted of 5-fluorouracil (370 mg/m2) plus folinic acid (200 mg/m2) administered daily for 5 days every 4 weeks for 6 cycles. Patients' perceptions of their own health status were obtained by means of 3 self-administered questionnaires, which were completed by patients at the time of discharge from the treatment center and at 6 and 24 months after randomization. RESULTS: Overall, 888 patients with resected Dukes B2 and C colon carcinoma were enrolled in the trial. HD-FUFA significantly reduced mortality by 25% (95% confidence interval, 5-41%; P=0.02) and events by 31% (95% confidence interval, 14-45%; P < or = 0.001). Compliance with treatment was good; more than 80% of patients completed the planned therapy. Toxicity was mild, and oral mucositis was the main side effect. None of the health-related quality-of-life parameters investigated (emotional status, worry about the future, changes in social life, impact of the disease, follow-up, and global quality of life) seemed to be affected by the treatment to which patients were allocated. A positive trend in the evolution of patients' psychologic status was observed. CONCLUSIONS: Long term results of this SITAC study confirm that HD-FUFA is a well-tolerated, effective 6-month adjuvant regimen for patients with colon carcinoma that has no detrimental effect on their quality of life.
Adult↗
The Italian SF-36 Health Survey: translation, validation and norming.
This article reports on the development and validation of the Italian SF-36 Health Survey using data from seven studies in which an Italian version of the SF-36 was administered to more than 7000 subjects between 1991 and 1995. Empirical findings from a wide array of studies and diseases indicate that the performance of the questionnaire improved as the Italian translation was revised and that it met the standards suggested by the literature in terms of feasibility, psychometric tests, and interpretability. This generally satisfactory picture strengthens the idea that the Italian SF-36 is as valid and reliable as the original instrument and applicable and valid across age, gender, and disease. Empirical evidence from a cross-sectional survey carried out to norm the final version in a representative sample of 2031 individuals confirms the questionnaire's characteristics in terms of hypothesized constructs and psychometric behavior and gives a better picture of its external validity (i.e., robustness and generalizability) when administered in settings that are very close to real world.
Cross-Cultural Comparison↗
Evaluation of the EORTC QLQ-C30 questionnaire: a comparison with SF-36 Health Survey in a cohort of Italian long-survival cancer patients.
BACKGROUND: Despite the large amount of data available about the EORTC QLQ-C30 questionnaire, there have been very few studies focussed on long-survival cancer patients, and no data are available on its performance in the Italian setting. PATIENTS AND METHODS: Within the framework of a project aimed at evaluating the characteristics of available HR-QOL questionnaires in the Italian language, the EORTC QLQ-C30 questionnaire together with the Short Form 36-item Health Survey (SF-36) were mail-administered to a sample of patients previously recruited in two large multicenter randomized clinical trials on early breast and colon cancers. The properties of the questionnaire were evaluated using standard psychometric techniques and correlation analyses with demographic and clinical independent variables. RESULTS: In the sample of patients who sent back the questionnaires under evaluation, the EORTC QLQ-C30 showed satisfactory acceptability (response rate = 64% and very low prevalence of missing at item and scale level), and the psychometric analyses confirmed the multi-dimensional conceptualisation in terms of convergent and discriminant validity. Moreover, EORTC QLQ-C30 scales showed substantial correlation with the homologous SF-36 scales. Few socio-demographic (age, gender, schooling) and clinical (type of cancer disease) variables were associated with HR-QOL. Breast cancer patients reported, on average, worse physical health-related scores, but after adjustment for age and education, most of the differences disappeared. CONCLUSIONS: These findings confirm the validity and robustness of the EORTC QLQ-C30 in this sample of long-survival Italian cancer patients. Further ad hoc validation studies are required to evaluate its significance in these particular patients.
Adult↗
Review of the concept of quality of life assessment and discussion of the present trend in clinical research.
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Health Status↗