The relevance of the contribution of psychoneuroendocrinoimmunology and psychology of reasoning and decision making to nursing science: A discursive paper.

AIM: Patients' death or adverse events appear to be associated with poor healthcare decision-making. This might be due to an inability to have an adequate representation of the problem or of the connections among problem-related elements. Changing how a problem is formulated can reduce biases in clinical reasoning. The purpose of this article is to explore the possible contributions of psychoneuroendocrinoimmunology (PNEI) and psychology of reasoning and decision-making (PRDM) to support a new nursing theoretical frame. DESIGN: Discursive paper. METHOD: This article discusses the main assumptions about nursing and nurses' ability to face patient's problems, suggesting a new approach that integrates knowledge from PNEI and PRDM. While PNEI explains the complexity of systems, highlighting the importance of systems connections in affecting health, PRDM underlines the importance of the informative context in creating a mental representation of the problem. Furthermore, PRDM suggests the need to pay attention to information that is not immediately explicit and its connections. CONCLUSION: Nursing recognizes the patient-nurse relationship as the axiom that governs care. The integration of PNEI and PRDM in nursing theoretics allows the expansion of the axiom by providing essential elements to read a new type of relationship: the relationship among information. PNEI explains the relationships between biological systems and the psyche and between the whole individual and the environment; PRDM provides tools for the nurse's analytical thinking system to correctly process information and its connections. IMPACT ON NURSING PRACTICE: A theoretical renewal is mandatory to improve nursing reasoning and nursing priority identification. Integrating PNEI and PRDM into nursing theoretics will modify the way professionals approach patients, reducing cognitive biases and medical errors. NO PATIENT OR PUBLIC CONTRIBUTION: There was no patient or public involvement in the design or writing of this discursive article.

Well-being trajectories in breast cancer and their predictors: A machine-learning approach.

OBJECTIVE: This study aimed to describe distinct trajectories of anxiety/depression symptoms and overall health status/quality of life over a period of 18 months following a breast cancer diagnosis, and identify the medical, socio-demographic, lifestyle, and psychological factors that predict these trajectories. METHODS: 474 females (mean age = 55.79 years) were enrolled in the first weeks after surgery or biopsy. Data from seven assessment points over 18 months, at 3-month intervals, were used. The two outcomes were assessed at all points. Potential predictors were assessed at baseline and the first follow-up. Machine-Learning techniques were used to detect latent patterns of change and identify the most important predictors. RESULTS: Five trajectories were identified for each outcome: stably high, high with fluctuations, recovery, deteriorating/delayed response, and stably poor well-being (chronic distress). Psychological factors (i.e., negative affect, coping, sense of control, social support), age, and a few medical variables (e.g., symptoms, immune-related inflammation) predicted patients' participation in the delayed response and the chronic distress trajectories versus all other trajectories. CONCLUSIONS: There is a strong possibility that resilience does not always reflect a stable response pattern, as there might be some interim fluctuations. The use of machine-learning techniques provides a unique opportunity for the identification of illness trajectories and a shortlist of major bio/behavioral predictors. This will facilitate the development of early interventions to prevent a significant deterioration in patient well-being.

Personalized Risk Analysis to Improve the Psychological Resilience of Women Undergoing Treatment for Breast Cancer: Development of a Machine Learning-Driven Clinical Decision Support Tool.

BACKGROUND: Health professionals are often faced with the need to identify women at risk of manifesting poor psychological resilience following the diagnosis and treatment of breast cancer. Machine learning algorithms are increasingly used to support clinical decision support (CDS) tools in helping health professionals identify women who are at risk of adverse well-being outcomes and plan customized psychological interventions for women at risk. Clinical flexibility, cross-validated performance accuracy, and model explainability permitting person-specific identification of risk factors are highly desirable features of such tools. OBJECTIVE: This study aimed to develop and cross-validate machine learning models designed to identify breast cancer survivors at risk of poor overall mental health and global quality of life and identify potential targets of personalized psychological interventions according to an extensive set of clinical recommendations. METHODS: A set of 12 alternative models was developed to improve the clinical flexibility of the CDS tool. All models were validated using longitudinal data from a prospective, multicenter clinical pilot at 5 major oncology centers in 4 countries (Italy, Finland, Israel, and Portugal; the Predicting Effective Adaptation to Breast Cancer to Help Women to BOUNCE Back [BOUNCE] project). A total of 706 patients with highly treatable breast cancer were enrolled shortly after diagnosis and before the onset of oncological treatments and were followed up for 18 months. An extensive set of demographic, lifestyle, clinical, psychological, and biological variables measured within 3 months after enrollment served as predictors. Rigorous feature selection isolated key psychological resilience outcomes that could be incorporated into future clinical practice. RESULTS: Balanced random forest classifiers were successful at predicting well-being outcomes, with accuracies ranging between 78% and 82% (for 12-month end points after diagnosis) and between 74% and 83% (for 18-month end points after diagnosis). Explainability and interpretability analyses built on the best-performing models were used to identify potentially modifiable psychological and lifestyle characteristics that, if addressed systematically in the context of personalized psychological interventions, would be most likely to promote resilience for a given patient. CONCLUSIONS: Our results highlight the clinical utility of the BOUNCE modeling approach by focusing on resilience predictors that can be readily available to practicing clinicians at major oncology centers. The BOUNCE CDS tool paves the way for personalized risk assessment methods to identify patients at high risk of adverse well-being outcomes and direct valuable resources toward those most in need of specialized psychological interventions.

The iceberg of genomics: New perspectives in the use of genomics and epigenetics in oncology nursing clinical reasoning. A discursive paper.

BACKGROUND: Although, there is a wealth of information in the medical literature on the usefulness of genomic testing in assessing risk and its application in medical oncology decision making, there are no theoretical reflections in the nursing field. AIM: To understand the implications of molecular biology in nursing practice and highlight the role of Nursing Theory in guiding nurses' reasoning. MATERIALS AND METHODS: Searching literature published between 2000 and 2022 in Medline and Google Scholar. Scientific evidence was analysed by the authors expert in different fields. RESULTS: Based on the findings of the literature, concerns have been raised about the proper care of cancer patients who have a genomic risk profile determination. In particular, the absence of theoretical thinking and conceptual models that consider developments in molecular biology and their impact on nursing, in addition to the prevalence of heuristic thinking and the application of clinical patterns in nursing practice, could induce patient misjudgement with inadequate planning of preventive, curative, rehabilitative and educational nursing interventions. Nurses working in the field of oncology should be aware that the risk profile determined by genomics tests is merely the visible and stated portion of the cancer patient: the tip of iceberg. DISCUSSION: This study demonstrates how genomic testing takes into account a fraction of genes discovered in tumour tissue to establish a risk profile. This subset differs, for example, from the social genome, which can determine the risk of dementia, cancer and cardiovascular disease, but in response to social adversity. Nursing theory, which views the environment as a metaparadigm, must consider a conceptual model that can integrate the findings of genomic testing with recommendations from studies on the social genome of humans to make it easier to build nursing treatments that can better reduce these risks. CONCLUSION: A nursing theoretical discourse on genomics is a paramount requirement for developing effective nursing care.

Psychological characteristics and satisfaction for the whole-body MRI in cancer screening.

Whole-body magnetic resonance imaging (WB-MRI) is an all-in-one non-invasive technique that can be used also in early cancer diagnosis in asymptomatic individuals. The aim of this work was to identify the personal characteristics predicting the satisfaction for the WB-MRI in a sample of healthy subjects. Before undergoing a WB-MRI examination, 154 participants completed a questionnaire covering sociodemographics (age, gender, education), personality traits (agreeableness, conscientiousness, emotional stability, extroversion, openness), and expectations about the procedure (expected usefulness, risks, noise, lack of air, duration). After the examination, participants reported their satisfaction with the WB-MRI. Results showed that agreeableness had a significant and positive effect on satisfaction. Expectations about its utility and the possible noise had a positive effect on satisfaction. Expectations of lack of air showed a negative significant effect on satisfaction. Sociodemographics showed no significant effects. Our study confirmed the important impact of individuals' personality and expectations on satisfaction with the procedure. Moreover, it provides useful insights for developing consultations aimed at increasing the acceptability of the procedure.

From virtual to real healing: a critical overview of the therapeutic use of virtual reality to cope with mourning.

In recent years, virtual reality (VR) has been effectively employed in several settings, ranging from health care needs to leisure and gaming activities. A new application of virtual stimuli appeared in social media: in the documentary 'I met you' from the South-Korean Munhwa Broadcasting, a mother made the experience of interacting with the avatar of the seven-year-old daughter, who died four years before. We think that this new application of virtual stimuli should open a debate on its possible implications: it represents contents related to grief, a dramatic and yet natural experience, that can have deep psychological impacts on fragile subjects put in virtual environments. In the present work, possible side-effects, as well as hypothetical therapeutical application of VR for the treatment of mourning, are discussed.

Associations between Physical Exercise, Quality of Life, Psychological Symptoms and Treatment Side Effects in Early Breast Cancer.

Background: Identifying and understanding modifiable factors for the well-being of cancer patients is critical in survivorship research. We studied variables associated with the exercise habits of breast cancer patients and investigated if the achievement of exercise recommendations was associated with enhanced quality of life and/or psychological well-being. Material and Methods. 311 women from Finland, Portugal, Israel, and Italy receiving adjuvant therapy for stage I-III breast cancer answered questions about sociodemographic factors and physical exercise. Quality of life was assessed by the EORTC C30 and BR23 questionnaires. Anxiety and depression were evaluated using the HADS scale. Results: At the beginning of adjuvant therapy and after twelve months, 32% and 26% of participants were physically inactive, 27% and 30% exercised between 30 and 150 minutes per week, while 41% and 45% exercised the recommended 150 minutes or more per week. Relative to other countries, Finnish participants were more likely to be active at baseline and at twelve months (89% vs. 50%, p < 0.001 and 87% vs. 64%, p < 0.001). Participants with stage I cancer were more likely to be active at twelve months than those with a higher stage (80% vs. 70%,p < 0.05). The inactive participants reported more anxiety (p < 0.05) and depression (p < 0.001), lower global quality of life (p < 0.001), and more side effects (p < 0.05) than the others at twelve months. Accordingly, those who remained inactive or decreased their level of exercise from baseline to twelve months reported more anxiety (p < 0.01) and depression (p < 0.001), lower global quality of life (p < 0.001), and more side effects (p < 0.05) than those with the same or increased level of exercise. Conclusion: For women with early breast cancer, exercise was associated with a better quality of life, less depression and anxiety, and fewer adverse events of adjuvant therapy. Trial registration number: NCT05095675. Paula Poikonen-Saksela on behalf of Bounce consortium (https://www.bounce-project.eu/).

Cognitive, emotional, and behavioral mediators of the impact of coping self-efficacy on adaptation to breast cancer: An international prospective study.

OBJECTIVE: The main objective of this prospective multicenter study was to examine whether illness representations of control, affect, and coping behaviors mediate the effects of self-efficacy to cope with cancer on psychological symptoms and overall quality of life, in breast cancer patients. METHOD: Data from 413 women (Mean age = 54.87; SD = 8.01), coming from four countries (i.e., Finland, Israel, Italy, Portugal), who received medical therapy for their early breast cancer, were analyzed. Coping self-efficacy was assessed at baseline. Potential mediators were assessed three months later, and outcomes after six months. RESULTS: Coping self-efficacy was related to all mediators and outcomes. Illness representations of treatment control, positive and negative affect, and certain coping behaviors (mostly, anxiety preoccupation) mediated the effects of coping self-efficacy. Coping self-efficacy was related to each outcome through a different combination of mediators. CONCLUSIONS: Coping self-efficacy is a major self-regulation factor which is linked to well-being through multiple cognitive, emotional, and behavioral pathways. Enhancement of coping self-efficacy should be a central intervention goal for patients with breast cancer, towards promotion of their well-being.

Patients' health locus of control and preferences about the role that they want to play in the medical decision-making process.

Health locus of control (HLOC) may influence people's behavior regarding their health as well as their desires to be involved in the medical decision-making. Our study aimed to examine HLOC's relations with people's control preferences about the medical decision-making. A total of 153 people filled out the self-administered version of the Control Preference Scale and the Multidimensional Health Locus of Control Scale - form C. The most preferred role is the collaborative one. However, HLOC explained heterogeneity in people's control preferences: lower scores in external HLOC were related to a greater preference for the active and the collaborative role. From the personalized medicine perspective, an accurate evaluation of the patient's HLOC could help tailoring the decision-making process within the clinical context.

Patient empowerment for cancer patients through a novel ICT infrastructure.

As a result of recent advances in cancer research and "precision medicine" approaches, i.e. the idea of treating each patient with the right drug at the right time, more and more cancer patients are being cured, or might have to cope with a life with cancer. For many people, cancer survival today means living with a complex and chronic condition. Surviving and living with or beyond cancer requires the long-term management of the disease, leading to a significant need for active rehabilitation of the patients. In this paper, we present a novel methodology employed in the iManageCancer project for cancer patient empowerment in which personal health systems, serious games, psychoemotional monitoring and other novel decision-support tools are combined into an integrated patient empowerment platform. We present in detail the ICT infrastructure developed and our evaluation with the involvement of cancer patients on two sites, a large-scale pilot for adults and a small-scale test for children. The evaluation showed mixed evidences on the improvement of patient empowerment, while ability to cope with cancer, including improvement in mood and resilience to cancer, increased for the participants of the adults' pilot.

Preventing chemotherapy-induced alopecia: a prospective clinical trial on the efficacy and safety of a scalp-cooling system in early breast cancer patients treated with anthracyclines.

BACKGROUND: Chemotherapy-induced alopecia (CIA) is a distressing side effect of cancer therapy. The trial aimed to assess feasibility and effectiveness of scalp-cooling system DigniCap® to prevent CIA in primary breast cancer patients receiving an anthracycline containing adjuvant chemotherapy (CT). METHODS: Hair loss (HL) was evaluated by patient self-assessment and by the physician according to the Dean's scale at baseline and after each cycle of CT. The primary efficacy endpoint was the patient self-assessment HL score evaluated at least 3 weeks after completing CT. A Dean's scale score of 0-2 (i.e. HL ≤50%) was considered a success. RESULTS: From July 2014 to November 2016, 139 consecutive breast cancer patients were enrolled and received at least one treatment with scalp cooling. Fifty-six out of 131 evaluated patients successfully prevented HL (43%, 95% CI: 34-51%). Twenty-four patients (32%) discontinued the scalp cooling because of alopecia or scalp-cooling related AE, three patients had missing information on CIA, and 48 patients (64%) had a HL greater than 50% after CT. No serious AEs were reported. CONCLUSIONS: DigniCap® System resulted as a promising medical device to be safely integrated in supportive care of early breast cancer patients. Longer follow-up is needed to assess long-term safety and feasibility. CLINICAL TRIAL REGISTRATION NUMBER: NCT03712696.

Radioablation +/- hormonotherapy for prostate cancer oligorecurrences (Radiosa trial): potential of imaging and biology (AIRC IG-22159).

BACKGROUND: Prostate cancer (PCa) is the second most common cancer among men. New imaging-modalities have increased the diagnosed patients with limited number of metastasis after primary curative therapy, introducing so-called oligometastatic state. Stereotactic body radiotherapy (SBRT) is emerging as a low-toxicity treatment to erase PCa localizations and postpone androgen deprivation therapy (ADT). A deeper understanding of the predictive role of biomarkers is desirable for a targeted treatment selection and surveillance programs. The aims of the RADIOSA trial are: 1. Compare SBRT +/- ADT for oligorecurrent-castration-sensitive PCa (OCS-PCa) in terms of efficacy, toxicity and Quality of Life (QoL). 2. Develop biology/imaging based prognostic tool that allows identifying OCS-PCa subclasses. METHODS: This is a randomized phase II clinical trial, recruiting 160 OCS-PCa in 3 years, with progression-free survival (PFS) as primary endpoint. Three tasks will be developed: 1. Randomized clinical study (3 years for accrual and 2 years for follow-up and data analysis); 2. Imaging study, including imaging registration and METastasis Reporting and Data System (MET-RADS) criteria; 3. Pre-clinical study, development of a biobank of blood samples for the analysis of neutrophil-to-lymphocyte ratio and preparatory for a subsequent miRNA profiling. We aim to determine which arm is justified for testing in a subsequent Phase III trial. A decision-tree algorithm, based on prognosis, biological phenotype and imaging profile, will be developed. DISCUSSION: Recruiting will start in July 2019. SBRT will allow obtaining excellent PFS, local control, QoL and low toxicity. In SBRT arm, ADT deferral will allow for a drug-holiday, delaying the detrimental impact on QoL. A sufficient number of blood samples will be collected to perform biological patient profiling. A stratification tool will be established with an analysis of morphological and functional imaging, based on the use of MET-RADS criteria. So, in conclusion, RADIOSA aims to define the optimal management of bone/nodal PCa relapses in a SBRT regimen. This study will increase our knowledge on low-burden metastatic PCa in the era of high precision and high technology personalized medicine, offering highly effective therapy in terms of clinical outcome and cost-effectiveness. TRIAL REGISTRATION: The RADIOSA study was prospectively registered at clinicaltrials.gov ( NCT03940235 , May 2019).

E-cigarettes May Support Smokers With High Smoking-Related Risk Awareness to Stop Smoking in the Short Run: Preliminary Results by Randomized Controlled Trial.

Introduction: E-cigarettes may be positively used in tobacco cessation treatments. However, neither the World Health Organization nor the American Food and Drug Administration has recognized them as effective cessation aids. Data about the efficacy and safety of e-cigarettes are still limited and controversial. Methods: This was a double-blind randomized controlled study. The main focus of this article is on a secondary outcome of the study, that is, the assessment of effectiveness and safety of e-cigarettes in achieving smoking cessation in a group of chronic smokers voluntarily involved in long-term lung cancer screening. Participants were randomized into three arms with a 1:1:1 ratio: e-cigarettes (Arm 1), placebo (Arm 2), and control (Arm 3). All subjects also received a low-intensity counseling. Results: Two hundred ten smokers were randomized (70 to nicotine e-cigarettes, 70 nicotine-free placebo e-cigarettes, and 70 to control groups). About 25% of participants who followed a cessation program based on the use of e-cigarettes (Arm 1 and Arm 2) were abstinent after 3 months. Conversely, only about 10% of smokers in Arm 3 stopped. A Kruskal-Wallis test showed significant differences in daily cigarettes smoking across the three arms (K-W = 6.277, p = .043). In particular, participants in Arm 1 reported a higher reduction rate (M = -11.6441, SD = 7.574) than participants in Arm 2 (M = -10.7636, SD = 8.156) and Arm 3 (M = -9.1379, SD = 8.8127). Conclusions: Our findings support the efficacy and safety of e-cigarettes in a short-term period. E-cigarettes use led to a higher cessation rate. Furthermore, although all participants reported a significant reduction of daily cigarette consumption compared to the baseline, the use of e-cigarettes (including those without nicotine) allowed smokers to achieve better results. Implications: E-cigarettes increased the stopping rate as well as the reduction of daily cigarettes in participants who continued smoking. In fact, although all participants reported a significant reduction of tobacco consumption compared to the baseline, the use of e-cigarettes allowed smokers to achieve a better result. It could be worthwhile to associate this device with new ICT-driven models of self-management support in order to enable people to better handle behavioral changes and side effects. This is true for ready-to-quit smokers (such as our participants) but can also be advantageous for less motivated smokers engaged in clinical settings.

Validation of the Italian version of the abbreviated expanded prostate Cancer index composite (EPIC-26) in men with prostate Cancer.

BACKGROUND: This study aims to validate and evaluate the psychometric properties and reliability of the Italian version of the Expanded Prostate Cancer Index Composite - Short Form (EPIC-26), a measure of quality of life (QoL) for prostate cancer patients. METHODS: Two hundred and eighty-four prostate cancer patients completed the Italian version of the EPIC-26 questionnaire at 45 days (T1) and 3 months (T2) after robot-assisted radical prostatectomy (RARP). Psychometric properties were evaluated using structural equation modeling: the goodness of fit of the correlated five-factor model (CFFM) for the EPIC-26 was assessed using the confirmatory factor analysis (CFA), while longitudinal invariance was conducted to assess the ability of the EPIC-26 to measure QoL construct over time. Test-retest reliability was assessed as well by considering intraclass correlations. RESULTS: At T1, the CFFM model displayed a good fit to data. Similarly, the model showed an adequate fit also at T2. Results of the reliability analysis attested the acceptable internal consistency and test-retest reliability of each dimension: all Cronbach's alphas could be classified as acceptable (i.e., above .65) except for low Cronbach's alpha for hormonal dysfunction at T1 (i.e., .638) and urinary irritation at both waves. (i.e., respectively .585 and .518). Finally, psychometric properties were invariant over time and each of the five dimensions of QoL displayed from moderate (all ICCs above .500) to good test-retest reliability (i.e. ICC for urinary incontinence = .764). CONCLUSIONS: Results of the CFA and the measurement invariance analysis demonstrated the validity of the Italian version of the EPIC-26 to assess QoL in prostate cancer patients. Its reliability and good psychometric qualities are well-supported, thus providing a valid tool to assess health-related quality of life and its change over time in prostate cancer patients.

Hereditary lobular breast cancer with an emphasis on E-cadherin genetic defect.

Recent studies have reported germline CDH1 mutations in cases of lobular breast cancer (LBC) not associated with the classical hereditary diffuse gastric cancer syndrome. A multidisciplinary workgroup discussed genetic susceptibility, pathophysiology and clinical management of hereditary LBC (HLBC). The team has established the clinical criteria for CDH1 screening and results' interpretation, and created consensus guidelines regarding genetic counselling, breast surveillance and imaging techniques, clinicopathological findings, psychological and decisional support, as well as prophylactic surgery and plastic reconstruction. Based on a review of current evidence for the identification of HLBC cases/families, CDH1 genetic testing is recommended in patients fulfilling the following criteria: (A) bilateral LBC with or without family history of LBC, with age at onset <50 years, and (B) unilateral LBC with family history of LBC, with age at onset <45 years. In CDH1 asymptomatic mutant carriers, breast surveillance with clinical examination, yearly mammography, contrast-enhanced breast MRI and breast ultrasonography (US) with 6-month interval between the US and the MRI should be implemented as a first approach. In selected cases with personal history, family history of LBC and CDH1 mutations, prophylactic mastectomy could be discussed with an integrative group of clinical experts. Psychodecisional support also plays a pivotal role in the management of individuals with or without CDH1 germline alterations. Ultimately, the definition of a specific protocol for CDH1 genetic screening and ongoing coordinated management of patients with HLBC is crucial for the effective surveillance and early detection of LBC.

Psycho-cognitive predictors of burnout in healthcare professionals working in emergency departments.

BACKGROUND: Healthcare professionals working in emergency departments commonly experience high work pressure and stress due to witnessing human suffering and the unpredictable nature of the work. Several studies have identified variables that affect burnout syndrome, but poor data are available about the predictors of the different dimensions of burnout (depersonalisation, emotional exhaustion, professional inefficacy and disillusionment). Some research has suggested that alexithymia, coping style and decision-making style may predict burnout. DESIGN: We conducted a noninterventional study to investigate whether and how alexithymia, coping style and decision-making style are associated with the different dimensions of burnout. METHODS: We recruited a convenience sample of 93 healthcare professionals working in an Italian emergency departments. Participants completed a questionnaire assessing their level of burnout (the Link Burnout Questionnaire), and possible burnout predictors: decision-making style, alexithymia and the coping style. Four bivariate linear regressions were performed to define the predictors that characterised the dimensions of burnout. RESULTS: We found that an avoidant decision-making style and a difficulty to identify and describe feelings (a difficulty close to alexithymia even though not as severe) are strong predictors of some burnout dimensions. Individuals who experience relational depersonalisation are more likely to turn to religion as a way to cope. CONCLUSIONS: Our research shows that, to some extent, difficulties in emotion regulation and the attitude to avoid or postpone decisions characterised burnout. RELEVANCE TO CLINICAL PRACTICE: These results might be used to develop tailored psycho-educational interventions. This might help healthcare professionals to develop personal skills to cope with the critical conditions that characterise their work and to enable them to recognise potential risk factors that favour burnout. This has pivotal implications for the maintenance of the patient-healthcare professional relationship and in reducing clinical errors.

How many research nurses for how many clinical trials in an oncology setting? Definition of the Nursing Time Required by Clinical Trial-Assessment Tool (NTRCT-AT).

Few resources are available to quantify clinical trial-associated workload, needed to guide staffing and budgetary planning. The aim of the study is to describe a tool to measure clinical trials nurses' workload expressed in time spent to complete core activities. Clinical trials nurses drew up a list of nursing core activities, integrating results from literature searches with personal experience. The final 30 core activities were timed for each research nurse by an outside observer during daily practice in May and June 2014. Average times spent by nurses for each activity were calculated. The "Nursing Time Required by Clinical Trial-Assessment Tool" was created as an electronic sheet that combines the average times per specified activities and mathematic functions to return the total estimated time required by a research nurse for each specific trial. The tool was tested retrospectively on 141 clinical trials. The increasing complexity of clinical research requires structured approaches to determine workforce requirements. This study provides a tool to describe the activities of a clinical trials nurse and to estimate the associated time required to deliver individual trials. The application of the proposed tool in clinical research practice could provide a consistent structure for clinical trials nursing workload estimation internationally.

The Paradox of Pelvic Exenteration: The Interaction of Clinical and Psychological Variables.

OBJECTIVES: To text the feasibility of a psychological intervention package administered to 49 pelvic exenteration candidates, aimed at evaluating the preoperative prevalence of psychological distress and assessing the presence of any correlation between preoperative psychological distress and clinical variables such as pain and hospitalization length. METHODS: Patients were referred to the psychology unit from the very beginning of their clinical pathway and were administered the Psychological Distress Inventory (PDI) and the Mini-Mental Adjustment to Cancer (Mini-MAC) questionnaire at prehospital admission. Patients presenting with a significant level of distress received nonstandardized psychological support. Statistical analyses were performed to detect the presence of any correlation between psychological variables at prehospital admission and clinical outcomes. RESULTS: The 40% of patients had significant levels of distress at prehospital admission (PDI ≥ 30). As regards Mini-MAC, the mean value of fighting spirit attitude and fatalism was higher in our sample than in the normative sample of the Mini-MAC validation study in the Italian cancer population. Their anxious preoccupation attitude was lower. There were no correlations between clinical and psychological variables: level of postsurgery pain was higher (3.7) in the subgroup of patients with presurgery PDI < 30 compared with those with PDI ≥ 30 (3.5). However, this difference was not statistically significant (P = 1.00). Considering hospitalization length, the above described trend was similar. CONCLUSIONS: Although highly distressed, pelvic exenteration candidates show an adaptive range of coping mechanisms. This calls for a greater effort in studying the complexity of their psychoemotional status to provide them with the best multidisciplinary care. Extensive study of the real effectiveness of psychological intervention is warranted: randomized clinical trials could help in detecting the presence of any correlation between clinical and psychological variables in a multidisciplinary approach.