1,721,065 research outputs found

    Decision-Making Process Related to Participation in Phase I Clinical Trials : a Nonsystematic Review of the Existing Evidence

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    Due to the lack of other treatment options, patient candidates for participation in phase I clinical trials are considered the most vulnerable, and many ethical concerns have emerged regarding the informed consent process used in the experimental design of such trials. Starting with these considerations, this nonsystematic review is aimed at analyzing the decision-making processes underlying patients' decision about whether to participate (or not) in phase I trials in order to clarify the cognitive and emotional aspects most strongly implicated in this decision. Considering that there is no uniform decision calculus and that many different variables other than the patient-physician relationship (including demographic, clinical, and personal characteristics) may influence patients' preferences for and processing of information, we conclude that patients' informed decision-making can be facilitated by creating a rigorously developed, calibrated, and validated computer tool modeled on each single patient's knowledge, values, and emotional and cognitive decisional skills. Such a tool will also help oncologists to provide tailored medical information that is useful to improve the shared decision-making process, thereby possibly increasing patient participation in clinical trials

    Understanding cognitive processes behind acceptance or refusal of phase I trials

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    Participation in phase I trials gives patients the chance to obtain control over their disease by trying an experimental therapy. The patients' vulnerability, the informed consent process aiming at understanding the purpose and potential benefits of the phase I trial, and the complexity of the studies may impact the patient's final decision. Emotionally difficult health conditions may induce patients to succumb to cognitive biases, allocating attention only on a part of the provided information. Filling the gap in patients' information process can foster the implementation of strategies to help physicians tailor clinical trials' communication providing personalized support and tailored medical information around patients' need, so avoiding cognitive biases in patients and improving informed shared decision quality.The aim of the present review article focuses on the analysis of cognitive and psychological factors that affect patients' decision to participate or not to early phase clinical trials

    Translation, cross-cultural adaptation, and reliability, of the Italian version of the Passive Risk Taking (PRT) Scale

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    The concept of “passive risk taking”, which refers to the risk brought on or magnified by inaction, has recently appeared in the literature on risk taking. Keinan and Bereby-Meyer (2012) have developed a scale to measure the personal tendency for passive risk taking (PRT); the scale has criterion validity and high test-retest reliability; it correlates with reported passive risk taking in everyday life and with the DOSPERT scale. Furthermore, it presents divergent validity from classic risk-taking constructs such as sensation seeking, and convergent validity with procrastination and avoidance. In this paper we propose a validation of the PRT scale in Italian. We performed the linguistic adaptation to Italian via the five steps suggested by Guillemin and colleagues (1993) and Beaton and colleagues (2000); we then submitted the derived questionnaire to a 297- adult sample. Results show that two out of three factors from the original scale were confirmed. However the third factor, originally composed of 6 items, was not consistent. We present the scale derived from such results, and discuss the differences with the original scal

    The role of emotions in cancer patients' decision-making

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    Objectives: We performed an observational prospective cohort study to investigate post-traumatic stress symptoms, emerging after cancer diagnosis, which could influence patients’ short- and long-term adjustment to illness, in order to foster screening measures and management of psychological factors in daily clinical pathways. Methods: Patients’ post-traumatic stress symptoms, psychological well-being and perceived quality of life were assessed through standardised questionnaires. The Profile of Mood States questionnaire was administered at pre-operative assessment (T0), surgical admission (T1) and discharge from hospital (T2). The Impact of Event Scale and the State-Trait Anxiety Inventory were administered at T0, T1, T2 and 2 years after discharge (T3). At 2-year follow-up, women were also asked to rate their perceived quality of life on a 0–10 visual analogue scale. Results: Between January 2014 and April 2015, 150 women were enrolled. Results showed that more than 90% of patients experienced post-traumatic stress symptoms after cancer diagnosis (14% with severe symptoms and 76.7% with moderate symptoms) and posttraumatic stress disorder (PTSD) symptoms that persisted up to the 2-year from discharge follow-up, with significant improvement only 2 years after hospital discharge. In particular, mediation models showed that intrusive thoughts impede mood adjustment to the disease during the pre-surgical phase, with anxiety amplifying the negative effect, while symptoms of avoidance are more detrimental in the long term for patients’ quality of life. Conclusion: PTSD symptom clusters have different influence on short- and long-term reaction to illness. Based on this evidence, appropriate interventions to manage PTSDs in the context of oncology should be develope

    Document Professor Umberto Veronesi : a physician, a researcher, a brilliant man

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    Many of those who work in oncology or deal with cancer patients know of Prof. Umberto Veronesi and none of them could deny the importance of his battle against cancer. He devoted his life to improving cancer treatment and quality of life for patients. He was a physician, and a politician, but above all he was a researcher. He embodied the true spirit of research, i.e., to believe in something and investigate every aspect of it until all the questions about it have been satisfactorily answered. He never gave up when faced with challenges, and he never stopped being curious. He believed in science, because he wanted to believe in the future. He mixed scientific knowledge with human warmth and was the pioneer of many breast cancer innovations. From the beginning of Prof. Veronesi's career, his mission was clear: 'My first decision was to focus on the fight against cancer. When I started at the National Cancer Institute in Milan, I felt a profound sense of rebellion against the surrender of doctors and patients to a disease that caused intense suffering. In particular, I could not stand the havoc of a woman's body after a mastectomy: in order to remove just a small breast cancer, not only the breast was taken away from the body, but also the axillary lymph nodes and the chest muscles. Consequently, I decided to fight mainly against breast cancer. It was a tough war: the dogma of mastectomy was so deeply-rooted that everybody thought I was crazy when I suggested conservative breast surgery
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