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Background: Prenatal information may be obtained through invasive diagnostic procedures and non-invasive screening procedures. Several psychological factors are involved in the decision to undergo a non-invasive prenatal testing (NIPT) but little is known about the decision-making strategies involved in choosing a specific level of in-depth NIPT, considering the increased availability and complexity of NIPT options. The main aim of this work is to assess the impact of psychological factors (anxiety about pregnancy, perception of risk in pregnancy, intolerance to uncertainty), and COVID-19 pandemic on the type of NIPT chosen, in terms of the number of conditions that are tested. Methods: A self-administered survey evaluated the decision-making process about NIPT. The final sample comprised 191 women (Mage = 35.53; SD = 4.79) who underwent a NIPT from one private Italian genetic company. Based on the test date, the sample of women was divided between "NIPT before COVID-19" and "NIPT during COVID-19". Results: Almost all of the participants reported being aware of the existence of different types of NIPT and more than half reported having been informed by their gynecologist. Results showed no significant association between the period in which women underwent NIPT (before COVID-19 or during COVID-19) and the preferences for more expanded screening panel. Furthermore, regarding psychological variables, results showed a significant difference between perceived risk for the fetus based on the NIPT type groups, revealing that pregnant women who underwent the more expanded panel had a significantly higher level of perceived risk for the fetus than that reported by pregnant women who underwent the basic one. There was no statistically significant difference between the other psychological variables and NIPT type. Conclusions: Our findings indicate the paramount role of gynecologist and other health care providers, such as geneticists and psychologists, is to support decision-making process in NIPT, in order to overcome people's deficits in genetic knowledge, promote awareness about their preferences, and control anxiety related to the unborn child. Decision-support strategies are critical during the onset of prenatal care, according to the advances in prenatal genomics and to parent's needs. [ABSTRACT FROM AUTHOR]

Background: Prostate cancer (PCa) is the second most common cancer in men worldwide. The standard non-surgical approach for localized PCa is radiotherapy (RT), but one of the limitations of high-dose RT is the potential increase in gastrointestinal and genitourinary toxicities. We present the protocol of the Microstyle study, a multicentre randomized two-arm crossover clinical trial. The primary outcome will be assessed at the end of 6-month intervention, by measuring the change in adherence to a healthy lifestyle score. The hypothesis is that modifying lifestyle we change microbiome and improve quality of life and decrease side effects of RT.Methods: Study participants will be recruited among men undergoing RT in two Italian centers (Milan and Naples). We foresee to randomize 300 patients in two intervention arms: Intervention Group (IG) and Control Group (CG). Participants allocated to the IG will meet a dietitian and a physiotherapist before RT to receive personalized diet and exercise recommendations, according to their health status, to improve overall lifestyle and reduce side effects (bowel and/or urinary problems). Dietitian and physiotherapist will work together to set individualized goals to reduce or eliminate side effects and pain according to their health status. All participants (IG) will be given a pedometer device (steps counter) in order to monitor and to spur participants to increase physical activity and reduce sedentary behavior. Participants included in the CG will receive baseline general advice and materials available for patients undergoing RT. According to the cross-over design, the CG will cross to the intervention approach after 6-month, to actively enhance compliance towards suggested lifestyle recommendations for all patients.Discussion: This trial is innovative in its design because we propose a lifestyle intervention during RT, that includes both dietary and physical activity counselling, as well as monitoring changes in microbiome and serum biomarkers. The promotion of healthy behaviour will be initiated before initiation of standard care, to achieve long lasting effects, controlling side effects, coping with feelings of anxiety and depression and improve efficacy of RT.Trial Registration: ClincalTrial.gov registration number: NCT05155618 . Retrospectively registered on December 13, 2021. The first patient was enrolled on October 22, 2021. [ABSTRACT FROM AUTHOR]

Background: Prostate cancer (PCa) is the second most common cancer in men worldwide. The standard non-surgical approach for localized PCa is radiotherapy (RT), but one of the limitations of high-dose RT is the potential increase in gastrointestinal and genitourinary toxicities. We present the protocol of the Microstyle study, a multicentre randomized two-arm crossover clinical trial. The primary outcome will be assessed at the end of 6-month intervention, by measuring the change in adherence to a healthy lifestyle score. The hypothesis is that modifying lifestyle we change microbiome and improve quality of life and decrease side effects of RT. Methods: Study participants will be recruited among men undergoing RT in two Italian centers (Milan and Naples). We foresee to randomize 300 patients in two intervention arms: Intervention Group (IG) and Control Group (CG). Participants allocated to the IG will meet a dietitian and a physiotherapist before RT to receive personalized diet and exercise recommendations, according to their health status, to improve overall lifestyle and reduce side effects (bowel and/or urinary problems). Dietitian and physiotherapist will work together to set individualized goals to reduce or eliminate side effects and pain according to their health status. All participants (IG) will be given a pedometer device (steps counter) in order to monitor and to spur participants to increase physical activity and reduce sedentary behavior. Participants included in the CG will receive baseline general advice and materials available for patients undergoing RT. According to the cross-over design, the CG will cross to the intervention approach after 6-month, to actively enhance compliance towards suggested lifestyle recommendations for all patients. Discussion: This trial is innovative in its design because we propose a lifestyle intervention during RT, that includes both dietary and physical activity counselling, as well as monitoring changes in microbiome and serum biomarkers. The promotion of healthy behaviour will be initiated before initiation of standard care, to achieve long lasting effects, controlling side effects, coping with feelings of anxiety and depression and improve efficacy of RT. Trial registration: ClincalTrial.gov registration number: NCT05155618. Retrospectively registered on December 13, 2021. The first patient was enrolled on October 22, 2021. [ABSTRACT FROM AUTHOR]

Background: Psychological health has been one of the aspects affected by the recent COVID-19 pandemic. We aim to evaluate the patterns of Google search for mental distress symptoms of Italian citizens during the various phases of the COVID-19 pandemic.Methods: We assessed Google searches for psychological-health related words. We gathered and analyzed data on daily search queries on depression, anxiety, and insomnia from Google Trends, in a time ranging from the Pre-COVID phase (beginning 25th January 2020) up to the second wave phase (ending 17th October 2020). We performed three general linear models on search trends of the three words and tested whether and to what extent official data about new cases of COVID-19, information searching on new cases, and the government health measures impacted on these trends.Results: Average daily search queries were higher for anxiety, followed by depression and insomnia. General linear models performed to assess differences in daily search queries for anxiety, depression and insomnia were significant, respectively [F(13, 253) = 6.80, P < .001]; [F(13, 253) = 10.25, P < .001]; [F(13, 253) = 6.61, P < .001]. Specifically, daily search queries differed among different phases of managing the COVID-19 outbreak: anxiety [F(5, 253) = 10.35, P < .001, [Formula: see text] = .17]; depression [F(5, 253) = 13.59, P < .001, [Formula: see text] = .21]; insomnia [F(5, 253) = 3.52, P = .004, [Formula: see text] = .07].Conclusions: Our study contributed to the investigation of online information-seeking behaviors of Italians regarding mental health throughout the entire phase of the pandemic and provides insights on the possible future trends of mental distress during upcoming pandemic phases. [ABSTRACT FROM AUTHOR]

Background: During the COVID-19 pandemic, between March and May 2020, in Italy, people were asked to shelter in place and most had to put their life on hold, while news of the spread of the virus constantly were broadcasted. The change in habits and the potential exposure to a dangerous virus can be categorized as a catastrophic event, which are usually traumatic and therefore have psychological consequences for the people involved.Objective: Assuming the COVID-19 pandemic as a possible traumatic event, this study aims to explore the contingent behavioural and psychological impact of COVID-19 spread and related lockdown on the Italian general population, through measuring anxiety and post-traumatic stress symptoms .Methods: An ad hoc-survey was set up for the this exploratory research, including the standardized Italian versions of the Impact of Event Scale Revised (IES-R) and the Generalized Anxiety Scale (GAD-7), and ad hoc items concerning behavioural reactions due to the pandemic spread and related mass quarantine. Participants were recruited across convenient web-based and mobile app channels using a snowball sampling technique. Data was collected from March 25th to May 1st, 2020.Participants: One-thousand one hundred and ninety-five individuals (851 women and 342 men) completed 60% or more of the survey and were considered for analyses. Mean age was 40 years (s.d. = 14.948). Participants resided in 78 Italian provinces (out of 107 territorial divisions), with 25.7% residing in the Milan province and 9.2% from the Monza and Brianza provinces, closest to the epicentre of the Italian outbreak.Results: During the worst months of the first wave of the Pandemic, the Italian population suffered high level of distress (GAD-7 m = 6.89, s.d. = 5.08; IER-R mean score = 27.86, s.d. 17.46), respectively indicating mild presence of anxiety symptoms, and high levels of PTSD symptoms. Gender seems to be a discriminating variable with women scoring significantly higher than man, both for anxiety symptoms (H (1) = 82.91, p < .001) and all dimensions of PTSD symptoms (intrusion H (1) = 71.23, p < .001, avoidance H (1) = 61.28, p < .001), and hyperarousal (H (1) = 67.348, p < .001). People from Generations Y and Z show to be at higher risk of developing PTSD (V = .746, F (3,1041) =1017.19, p = .001) and GAD symptoms (F (3,1041) = 5.113, p = .002) than older generations.Conclusions: Gender and generation appeared to be the most consistent risk factor for higher levels of generalized anxiety and PTSD symptoms in the current pandemic. Other variables - such as information seeking behaviours, parental and marriage status, chronic conditions - yielded less consistent evidence. Results indicate the need of including psychological interventions as a standard tool during the emergency management of a catastrophic events such as a pandemic. [ABSTRACT FROM AUTHOR]

Background: Most women with breast cancer experience a progressive weight gain during and after treatment. Obesity is associated with an increased risk of recurrence, contralateral breast cancer, and death. Physical activity after cancer diagnosis has been reported to have positive effects on body composition and quality of life. We present the protocol of the InForma study, a trial testing the efficacy of an intervention on weight loss (≥5 % of the baseline body weight) in a group of overweight or obese breast cancer survivors.Methods/design: This is a four-arm randomized controlled trial. Patients will receive a 6-month intervention and be followed for a further 18 months. Intervention is designed to improve adherence to a healthy diet and/or to increase physical activity, taking advantage of a wrist-based activity monitor. Participants will be recruited among overweight or obese breast cancer patients treated at the European Institute of Oncology, after completion of eventual adjuvant chemotherapy and/or radiotherapy. It is envisaged that 260 patients will be randomized into four arms: Dietary Intervention; Physical Activity Intervention; Physical Activity and Dietary Intervention; and Less Intensive Intervention. Women will be offered individualized counseling consisting of face-to face discussion and phone calls in addition to group meetings. A motivational interviewing approach will be used to encourage health behavior change. All participants will be given a pedometer device to monitor their physical activity. Participants' dietary intake will be repeatedly assessed using a validated food frequency questionnaire. Participants' quality of life and anxiety will be assessed with the Functional Assessment of Cancer Therapy-Breast and the State-Trait Anxiety Inventory questionnaires. Blood samples will be collected at baseline and follow-up visits to assess lipid and hormone profiles. Body composition will be repeatedly assessed using bioelectrical impedance vector analysis for identifying changes of fat and fat-free mass. Women allocated to the less intensive intervention arm will be considered as the control group.Discussion: While there is a rising concern about the role of obesity in cancer recurrence and survival, this trial with its multi-arm design, motivational approach and use of a pedometer device will provide important insights regarding the most effective approach in promoting weight control in breast cancer survivors.Trial Registration: ISRCTN53325751 (registration date: 16 October 2015); ClinicalTrials.gov NCT02622711 (registration date: 2 December 2015). [ABSTRACT FROM AUTHOR]

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). [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]