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Aims and Background This study is aimed at evaluating the effectiveness of a physician-centered communication skills training program on cancer patient anxiety levels. Methods and Study design In this quasi-experimental study, physicians from 9 units of 5 general hospitals and 1 cancer research institute were recruited. The unit heads chose which physicians would attend the training program (treatment group) and which would not (control group). The effectiveness of the course was evaluated by assessing the evolution of state anxiety in a sample of cancer patients before and after clinical consultations. Results Thirty-eight physicians and 339 outpatients were assessed. Patients from the treatment and control groups did not differ in pre-examination anxiety or psychological distress levels. Patients examined by physicians from the treatment group displayed a higher decrease in state-anxiety levels compared with those examined by physicians from the control group. A higher proportion of high anxiety levels was found in women, in less educated patients, and in those with a high distress level. Conclusions Our findings suggest the effectiveness of the communication skills training program with reference to patient anxiety levels. Given the potential gap between training and clinical impact, further studies investigating the effect of communication training on patient outcomes are needed.

This study was performed to describe the impact of preventive options on the psychological condition of BRCA1/BRCA2 carriers. A sample of 52 cancer-affected (C-A) and 27 cancer-unaffected (C-UN) women were enrolled after gene test disclosure (T0). Psychological evaluations were performed at T0 and 15 months later (T1). The surgical options were more likely to be chosen in C-A women (62%), although a consistent proportion of C-UN women (30%) also opt for these preventive measures. At the baseline, both samples had average anxiety and depression scores below the cut-off value, restrained average cancer worry scores and a risk perception consistent with the risk percentage provided during genetic counselling. The longitudinal results indicated no clinically meaningful variations in the anxiety and depression scores in either of the two samples. Statistically significant reductions in cancer-risk perception emerged in women who chose surgery in both C-A and C-UN women. In BRCA1/BRCA2 mutation carriers, surveillance does not influence their initial psychological condition, whereas prophylactic surgery has a significant impact in reducing the perceived risk and worry about getting sick. C-A and C-UN women have to be considered as two separate populations of BRCA mutation carriers requiring personalized approaches to risk management.

Objective: This study aims at describing the emotional and practical experience of a representative sample of Italian non-professional caregivers when caring for a terminally ill family member and is part of the ‘Italian Survey of the Dying of Cancer’, which involved 2000 adult cancer deaths representative of the whole country. Methods: Information on patients' experience was gathered from non-professional caregivers by an interview. A specific question was asked about the caregivers' emotional and practical experiences while assisting a terminally ill relative. A content analysis of the open question on caregivers' perceptions was performed on transcribed answers. Three researchers independently generated categories. Subsequently, areas where they differed were reconsidered and an interpretation was agreed upon. Results: Valid interviews were obtained from 1231 non-professional caregivers. Answers were classified according to the perception of the experience as positive (33.1%), negative (65.1%) or neutral (1.8%). Conclusion: Assisting a family member with cancer in his/her last three months of life is a very strong physical and mental stress for the caregiver. In some cases, this experience is nevertheless perceived as an evolution chance. Health-care providers should need to develop programs to ensure that family caregivers' needs for information and support are given great importance. Copyright © 2008 John Wiley & Sons, Ltd.

Despite the fact that scientific statements coming from several toxicological studies provide a strong indication of the low risk of pesticides residues [Bolognesi, C., Morasso, G. (in press) ‘Genotoxicity of Pesticides: Potential Risk for Consumers’ Food Science & Technology] , the general population does not seem to have the same assurances as experts: consumers' perception may widely differ from the orientation offered by health authorities 6 , 7 , 8 , 9 , 10 . This cognitive-evaluative process may affect personal behaviour or lifestyle and may induce consumers to reduce or eliminate the use of certain foods which they feel contain pesticides 17 , 18 . Therefore, authorities and educational experts should take objective assessment as well as subjective risk perception into account to come to a higher awareness in the accomplishment of an appropriate food choice. Following this premise and owing to the lack and unsuitability of information on the way pesticides are used in Italy, a new information system on food, called NAFSA, was created to increase consumers' awareness.

Pesticide residues in vegetables and fruits continue to generate concern in the general population mainly about their potential long term adverse effects such as cancer. The pesticides currently in use include a wide variety of compounds belonging to different chemical classes. More than 800 chemicals marketed as multiple formulations, are used in the European Union, as insecticides, herbicides, fungicides. Pesticides have been considered potential chemical mutagens. Experimental data revealed that various agrochemical ingredients possess mutagenic properties inducing gene mutation, chromosomal alteration or DNA damage. The genotoxic potential for agrochemical ingredients is generally low: they give positive results in few genotoxicity tests. In human biomonitoring studies genetic damage associated with pesticides has been detected for high exposure levels and intensive use. The genetic effects depend on quantity and variety of chemical formulations consumed. Improvements of agricultural practices and of safety of work conditions has reduced the genotoxic hazard. The most recent studies failed to reveal genotoxic damage. This evidence suggests a negligible risk for general population exposed to very low levels of residues.

The study describes the initial phases of research aimed at developing a methodology for assessing awareness in cancer patients. A first sample of cancer patients (n = 36) was interviewed about their knowledge of the diagnosis and their perception of treatment goals and outcomes. Thirteen domains which refer both to cognitive and emotional areas were identified, and considered as content valid by a panel of six experts. A second sample of patients (n = 54) participated in a semi-structured interview developed to explore awareness by means of the domains identified. Seven patterns of awareness were identified, ranging from 'completely aware patient' to 'completely unaware patient'. Twenty of the 54 patients (37.0%) were completely aware, 19 (35.2%) were partially aware with defence mechanisms and 15 (27.8%) were not aware of their diagnosis. Patients from the National Cancer Institute were more frequently aware (54.3%) compared with the patients interviewed in the community hospitals (5.3%) (p < 0.001). A computerized content analysis allowed the identification of two main groups of patients on the basis of the content of the recorded interviews. This independent classification agreed with the classification of the patients performed by the psychologists, suggesting the validity of the procedure of awareness evaluation proposed in this study.

Stage IIIb non-small-cell lung cancer (NSCLC) has a poor prognosis. The median survival is approximately 6 months, and only 30% of patients are alive 1 year after diagnosis. The need for effective treatment is evident. The aim of this study was to evaluate whether the infusion of tumor-infiltrating lymphocytes (TILs), isolated from resected tumor, expanded in vitro and injected together with recombinant Interleukin-2, is feasible and may at least partially modify the poor prognosis in these patients. The infusion of TILs, derived from surgically resected NSCLC and expanded in vitro, together with subcutaneous (s.c.) injections of recombinant interleukin-2 (rIL-2) was attempted in a group of 11 patients. Treated patients were infused i.v. with in vitro expanded TILs (from 4 to 70 x 10(9) cells), and rIL-2 was injected s.c. at doses varying from 61 to 378 x 10(6) IU. Toxic side effects (fever and, in some cases, hypotension) were observed and limited the dose of rIL-2 infused. Follow-up was continued for 40 months. The mean survival time was 13.8 months. Three of five TIL-treated patients with residual disease have no evident disease after 1 year, and two of them are still alive and have no evidence of disease after 40 months. This pilot study suggests that the infusion of in vitro expanded TILs, derived from surgical samples, is feasible and seems to prolong overall survival and to control the residual disease in patients with advanced NSCLC.

Screening for psychological distress in cancer patients is important, considering the high prevalence of psychiatric disorders responsive to treatment. The aim of this study is to test the psychometric properties of the Psychological Distress Inventory (PDI), a 13-item self-administered questionnaire developed to measure psychological distress in cancer patients.The PDI was tested in three samples of 434 cancer patients. In the first sample (n = 102) it was administered with the State Trait Anxiety Inventory (STAI) and with the Eysenck Personality Questionnaire (EPQ). Its validity as a screening method for psychiatric disorders was evaluated through a clinical interview in the second sample (n = 107). The third sample (n = 225) provided information on the ability of the PDI to discriminate among patients in different clinical phases of disease and allowed an estimate of the prevalence of psychiatric disorders in these groups of patients.A 0.88 alpha coefficient was obtained in the whole study sample. The correlations with the STAI scales were0.70. A positive correlation with neuroticism (r = 0.59) and a negative correlation with extroversion (r = -0.34) was observed. In the second sample, 67 patients (62.6%) received a psychiatric diagnosis according to the ICD-X criteria. The mean PDI scores were significantly lower for the 40 patients with no psychiatric diagnosis (mean 24.5) as compared with the 49 patients with adjustment disorders (mean 36.4) and with the 12 patients with depressive disorders (mean 40.8). The area under curve, estimated through a Receiver-Operating Characteristics analysis, was 0.88. A cut-off of 29 was associated with a 75% sensitivity and a 85% specificity. In the third sample, the lowest PDI scores were in patients with no evidence of disease (mean 24.7, 95% CL 23.0-26.4) as compared to patients undergoing antineoplastic treatment (mean 30.9, 95% CL 28.9-32.9) and to patients under palliative therapy (mean 36.0, 95% CL 34.0-37.9). The estimated prevalence of patients with psychiatric disorders in these three groups were respectively 5.0, 56.6 and 98.8%.Our results suggest that the PDI is a reliable and valid tool for measuring psychological distress in cancer patients and to detect psychiatric disorders through a screening procedure.

This study is aimed at evaluating the feasibility of a screening procedure for psychological distress in cancer survivors. Consecutive series of 339 cancer patients from three centres were requested to fill in two questionnaires measuring psychological distress (PDI) and social support (MOSS). Psychological intervention was offered to patients with significant degree of distress. Most patients accepted to be screened (72.0%; n = 244), and a subgroup (16.0%) showed high psychological distress. A higher ratio of distressed patients was observed among those with lower social support (P = 0.017). A significant (P

Abstrac Background: The observed cultural changes in truth-telling attitudes suggest a radical change in the practice of delivering information to cancer patients, but limited research is available from countries known for their policy of non-disclosure. This study estimates the proportion of Italian who died of cancer who had received information about diagnosis and prognosis, and explores the variables associated with disclosure. Materials and methods: This is a mortality follow-back survey of 1271 non-professional caregivers of Italians who died of cancer in 2002, representative of the approximate 160 000 Italian annual cancer deaths. Caregivers were interviewed after the patient's death about the process of diagnosis and prognosis disclosure. Results: It was estimated that 37% of people who died of cancer had received information about diagnosis and 13% about poor prognosis. A consistent proportion, although non-informed, knew the diagnosis (29%) and the poor prognosis (50%). The probability to be informed was higher for patients living in the north of Italy, young, well educated, with longer survival, and with breast or head and neck tumor. Conclusions: These findings suggest that not necessarily the observed cultural changes towards a less paternalistic approach in medical care translate into an effective change in the quantity of information delivered to the patients.

In order to improve outcome, new, often more toxic chemotherapy regimens are continuously investigated in early breast cancer patients. Because the expected survival improvement is small, the possible increase in the negative effects of the new treatments should be carefully evaluated. Negative effects are represented not only by acute and chronic toxicity, but also by the adverse psychological impact of chemotherapy. The aim of this study was to evaluate the effect on patient-reported psychological distress of an increase in the dose-intensity of adjuvant chemotherapy compared with a standard regimen. Psychological distress was evaluated at baseline, during chemotherapy and after 6 and 12 months in breast cancer patients enrolled in a phase III multicentre study comparing the standard adjuvant chemotherapy with cyclophosphamide, epirubicin and 5-fluorouracil every 21 days (CEF21) with the same chemotherapy given every 14 days (CEF14). 392 patients were randomised in participating centres, and 363 were evaluable for this study. Overall, 1095 out of 1446 expected questionnaires (75.7%) were collected and evaluable. At baseline, the mean scores of psychological distress were similar in the two arms. During chemotherapy, a significantly higher psychological distress was observed in the CEF14 compared with the CEF21 arm (32.3 +/- 1.3 versus 27.6 +/- 1.3; P=0.009), as well as a higher cumulative incidence of anaemia, mucositis, diarrhoea, alopecia, bone pain and fatigue was observed in the CEF14 arm. In multivariate analyses, mucositis (P=0.01), asthenia (P=0.059), and CEF14 treatment (P=0.054) were independently associated with a higher psychological distress. After 6 months, psychological distress was again similar in the two arms and significantly lower when compared with baseline within each arm. A dose-intensive adjuvant regimen induces a higher, although transient, psychological distress in early breast cancer patients. Final results of the randomised trial will indicate whether such higher adverse effects of the dose-intensive regimen are counterbalanced by a higher efficacy of the experimental treatment in terms of survival.

Prediction of delayed psychiatric disorders in breast cancer patients by using a screening procedure was investigated. Two questionnaires, the Psychological Distress Inventory and the Hospital Anxiety and Depression Scale, were administered before and during chemotherapy, and at the first follow-up visit. A psychiatric diagnosis was assigned to 50 of the 132 patients (38%) evaluated at follow-up. Including a set of clinical and demographic variables in a logistic regression, increasing age (P=0.001) and psychiatric history (P

The psychometric properties of the Italian version of the Hospital Anxiety and Depression Scale and its utility as a screening instrument for anxiety and depression in a non-psychiatric setting were evaluated. The questionnaire was administered twice to 197 breast cancer patients randomised in a phase III adjuvant clinical trial: before the start of chemotherapy and at the first follow-up visit. The presence of psychiatric disorders was evaluated at the follow-up visit using the Structured Clinical Interview for DSM-III-R in 132 patients. Factor analyses identified two strictly correlated factors. Crohnbach's alpha for the anxiety and depression scales ranged between 0.80 and 0.85. At follow-up, 50 patients (38%) were assigned a current DSM-III-R diagnosis, in most cases adjustment disorders (24%) or major depressive disorder (10%). Receiver operating characteristics (ROC) analysis was used to test the discriminant validity for both anxiety and depressive disorders. The comparison of the areas under the curve (AUC) between the two scales did not show any difference in identifying either anxiety (P = 0.855) or depressive disorders (P = 0.357). The 14-item total scale showed a high internal consistency (alpha = 0.89 and 0.88) and a high discriminating power for all the psychiatric disorders (AUC = 0.89; 95% CI = 0.83-0.94). The cut-off point that maximised sensitivity (84%) and specificity (79%) was 10. These results suggest that the total score is a valid measure of emotional distress, so that the Italian version of HADS can be used as a screening questionnaire for psychiatric disorders. The use of the two subscales as a 'case identifier' or as an outcome measure should be considered with caution.

This study identified the needs of terminal cancer patients, investigated the factors associated with unmet needs, and assessed psychological and symptom distress associated with unsolved needs. Ninety-four patients were randomly selected from 324 patients admitted for palliative care in 13 Italian centers. Two self-administered questionnaires (the Symptom Distress Scale and the Psychological Distress Inventory) were administered to all the patients. Patients needs were identified using a semi-structured interview, aimed at exploring five areas: physiological needs, safety needs, love and belonging needs, self-esteem needs, self-fulfillment needs. A content analysis of the answers defined 11 needs, and identified patients with unmet needs. The most frequent unmet needs were symptom control (62.8%), occupational functioning (62.1%), and emotional support (51.7%). The less frequently reported needs were those related to personal care (14.6%), financial support (14.1%), and emotional closeness (13.8%). Low functional state was significantly associated with a high proportion of patients with unmet needs of personal care, information, communication, occupational functioning, and emotional closeness. Patients with unmet needs showed significantly higher psychological and symptom distress for most needs. This study provides some suggestions about the concerns that should be carefully considered during the late stage of cancer.