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BACKGROUND: Receiving a diagnosis of cancer is a profound and often very stressful experience. Few studies have prospectively recruited patients prior to receiving a new diagnosis of cancer and included spouses or partners. OBJECTIVE: The aim of the Couples Cope Study is to understand the impact of undergoing a diagnostic biopsy and receiving a new cancer diagnosis on quality of life (QoL) in both patients and their spouses or partners, as well as on the quality of their relationship. This protocol paper describes the study design and assesses the feasibility of recruitment and retention. METHODS: Study staff reviewed the schedules of collaborating physicians using specific encounter codes to identify patients scheduled for breast or prostate biopsies. Potential participants were prescreened via the electronic health record and sent a recruitment letter at least 2 to 3 weeks prior to their biopsy procedure. Patients subsequently underwent a phone screening to determine eligibility. Patients who enrolled provided study staff with contact information for their spouses or partners. All consent forms were completed online. Surveys were completed online prior to receiving the biopsy results (baseline), and at 1, 3, 6, and 9 months after the biopsy. Study staff engaged in ongoing, personalized contact with participants and sent assessment completion reminders via phone and email. RESULTS: A total of 2294 patients undergoing a breast or prostate biopsy were identified and 69% (n=1582) were eligible for phone screening following electronic health record prescreening. Of the 431 patients who underwent phone screening, 75% (n=321) were eligible to participate. Of the eligible patients, 72% (n=231) enrolled and 82% (n=190) of enrolled patients had an accompanying partner or spouse who also enrolled. A total of 77% (34/44) of patients who received a cancer diagnosis and 72% (26/36) of their spouses or partners were retained through 9 months, while 80% (53/66) of patients who received a benign diagnosis and 68% (42/62) of their partners were retained. CONCLUSIONS: Prospective recruitment of patients undergoing diagnostic biopsy and their partners is feasible and requires both strategic collaboration with providers and concerted prescreening and recruitment efforts by study staff. Importantly, this study was able to conduct all study activities online without disrupting clinical workflow and without requiring patients and their spouses or partners to come into the laboratory. Consideration should be given to the ratio of biopsies to cancer diagnoses, which can vary significantly by cancer type. Prospective studies are needed and can inform our ability to provide effective support earlier to couples facing a possible cancer diagnosis. Future studies should examine other tumor types that have received less attention in QoL studies, include behavioral and neurobiological assessments beyond self-report measures, and follow couples beyond 9 months in order to examine long-term effects on QoL. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52361.

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INTRODUCTION AND METHODS: Prostate biopsy (PB) is an essential step in the diagnosis and active surveillance of prostate cancer (PCa). Transperineal PB (TP-PB) is now the recommended approach and is mostly conducted under local anesthesia. However, this procedure can potentially cause anxiety for patients, given the oncological context and the fear of peri-procedural pain and complications. The objective of this narrative review is to summarize the currently available tools for the management of peri-interventional anxiety during TP-PB, with a particular emphasis on the potential role of virtual reality (VR) in this setting. RESULTS: In TP-PB, preoperative anxiety can lead to increased pain perception, longer procedure time, and decreased patient satisfaction. Pharmacological and non-pharmacological approaches have been explored to reduce anxiety, such as premedication, deep sedation, education, relaxation techniques, hypnosis, and music therapy, albeit with mixed results. VR has recently emerged in the technological armamentarium for managing pain and anxiety, and the efficiency of this technology has been evaluated in various medical fields, including pediatrics, gastroenterology, urology, gynecology, and psychiatry. CONCLUSION: Despite the paucity of available data, VR appears to be a safe and effective technique in reducing anxiety in many procedures, even in frail patients. No studies have evaluated the role of VR in TP-PB. Future research should thus explore the optimal way to implement VR technology and any potential benefits for TP-PB patients.

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BACKGROUND: Prostate cancer is the most commonly diagnosed neoplasm in men. From the introduction of PSA testing, an increasing number of men undergoes prostate biopsy (PBX). While the physical side effects of PBx have been well investigated, its psychological impact has been under-evaluated. AIM: The aim of our study is to investigate the presence of psychological distress (anxiety and depression) in patients waiting for histopathological results after prostate biopsy (PBx). METHODS: From February to April 2019, 51 consecutive patients undergoing prostate biopsies at our institution were included. Age, PSA, DRE, familiarity for prostate cancer, number of previous biopsies, type of anesthesia, number of cores were recorded. All patients filled the Hospital Anxiety and Depression Scale (HADS), a psychometric Likert-scale questionnaire, before receiving the histopathological results of their PBx. RESULTS: The prevalence of psychological distress among patients awaiting histopathologic results is 41% (21/51 patients), with anxiety being the main component of their distress. On multivariate analysis, PSA, family history, and repeat biopsy were significantly associated with anxiety and depression. CONCLUSION: Patients undergoing PBx experience a burden of psychological distress waiting for histopathologic results, especially anxiety. Appropriate counseling should be offered to patients at high risk of developing psychological distress after PBx. Future goals would include technological improvements to shorten the time between biopsy and definitive results.

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OBJECTIVES: Effective use of technology can provide advantages for both patients and physicians in skin biopsy practice. We aimed to investigate the effects of video-based information on the anxiety, pain and satisfaction levels of patients undergoing biopsy. METHODS: Patients were randomized and divided into two groups as video-informed and verbally informed. The anxiety levels were evaluated using the State-Trait Anxiety Inventory (STAI) and measuring the physiological parameters, systolic and diastolic blood pressure, heart rate, and respiratory rate. After the informing process, the STAI's state form was reevaluated, and physiological parameters were measured again. After the biopsy, the level of pain was evaluated using the visual analog scale (VAS), and patient satisfaction was assessed with the satisfaction scale. RESULTS: Fifty-two in the video-informed group and 50 in the verbally informed group completed the study. Compared to the baseline values, the STAI and STAI-state scores, systolic blood pressure, heart rate and respiratory rate of the patients in the video-informed group decreased (p < 0.0001, p < 0.0001, p = 0.003, p = 0.007, and p < 0.0001, respectively), and the systolic blood pressure, diastolic blood pressure, heart rate and respiratory rate values decreased in the verbally informed group (p < 0.0001, p = 0.014, p = 0.005, and p < 0.0001, respectively). According to VAS, 98.1% of the patients in the video-informed group and 86% of those in the verbally informed group described no or mild pain, and pain levels were lower in the video-informed group (p = 0.030). CONCLUSIONS: Video-based information prior to skin biopsy may be more useful in managing anxiety and pain in patients than traditional verbal information.

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Background: It is unknown whether the rate of psychiatric disorders and cardiovascular disease increases during the diagnostic workup of suspected prostate cancer. Methods: We designed a population-based cohort study including 579 992 men living during 2005-2014 in Skåne, Sweden, according to the Swedish Total Population Register and the Skåne Healthcare Register (SHR). We used the Swedish Cancer Register and the SHR to identify all men with a new diagnosis of prostate cancer (N = 10 996), and all men underwent a prostate biopsy without receiving a cancer diagnosis (biopsy group, N = 20 482) as exposed to a diagnostic workup. Using Poisson regression, we compared the rates of psychiatric disorders and cardiovascular disease during the period before diagnosis or biopsy of exposed men with the corresponding rates of unexposed men. Results: We found an increased rate of psychiatric disorders during the period before diagnosis or biopsy among men with prostate cancer (incidence rate ratio [IRR] = 1.87, 95% confidence interval [CI] = 1.67 to 2.10) and men in the biopsy group (IRR = 2.22, 95% CI = 2.08 to 2.37). The rate of cardiovascular disease increased during the period before diagnosis or biopsy among men with prostate cancer (IRR = 2.22, 95% CI = 2.12 to 2.32) and men in the biopsy group (IRR = 2.56, 95% CI = 2.49 to 2.63). Greater rate increases were noted for a diagnostic workup due to symptoms than due to other reasons. Conclusions: There was an increased risk of psychiatric disorders and cardiovascular disease during the diagnostic workup of suspected prostate cancer regardless of the final cancer diagnosis.

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BACKGROUND: The objective of this study was to describe the perspective of patients with early breast cancer toward research biopsies. The authors hypothesized that more patients at academic sites than at community-based sites would be willing to consider these procedures. METHODS: In total, 198 patients with early stage breast cancer were recruited from 3 academic centers (n = 102) and from 1 community oncology practice (n = 96). The primary objective was to compare the proportion of patients willing to consider donating excess tissue biospecimens from surgery, from a clinically indicated breast biopsy, or from a research purposes-only biopsy (RPOB) between practice types. RESULTS: Most patients (93% at academic sites, 94% at the community oncology site) said they would consider donating excess tissue from surgery for research. One-half of patients from academic or community sites would consider donating tissue from a clinically indicated breast biopsy. On univariate analysis, significantly fewer patients from academic sites would consider an RPOB (22% at academic sites, 42% at the community site; P = .003); however, this difference was no longer significant on multivariate analysis (P = .96). Longer transportation times and unfavorable prior experiences were associated with less willingness to consider an RPOB on multivariate analysis. Significantly fewer patients from academic sites (14%) than from the community site (35%) would consider a research biopsy in a clinical trial (P = .04). Contributing to scientific knowledge, return of results, and a personal request by their physician were the strongest factors influencing patients' willingness to undergo research biopsies. CONCLUSIONS: The current results rejected the hypothesis that more patients with early breast cancer at academic sites would be willing to donate tissue biospecimens for research compared with those at community oncology sites. These findings identify modifiable factors to consider in biobanking studies and clinical trials.

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INTRODUCTION: Percutaneous kidney biopsy has been established as a safe, reliable and minimally invasive method. This study aims to describe the author's experience with biopsy of the kidney and to compare the results in sitting position versus prone in terms of the complication rate. MATERIALS AND METHODS: Patients were divided into two groups: prone and sitting position according to the clinician's and patient's preference. Followed by kidney biopsy, a questionnaire was completed. Then, data and the mean number of glomeruli in each group were compared. RESULTS: Apart from sweat, presumably due to the prone position, no significant differences were found regarding the side effects including dizziness, seizure, nausea, and vomiting between the two groups. The number of glomeruli was not significantly different between two groups. CONCLUSION: In comparison with the prone position, kidney biopsy at sitting position is more comfortable at least for patients who seems couldn't tolerate prone position. We recommend sitting position for kidney biopsy owing to the low side effects rate of this diagnostic technique.

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The goal of this paper was to test Construct Validity of the Amsterdam Preoperative Anxiety and Information Scale (Italian Version) in women undergoing Breast Biopsy. To answer this purpose we have utilized Exploratory Factor Analysis (EFA) in a sample of 80 women undergoing Breast Biopsy at the Breast Unit of the Careggi University Hospital in Florence from January to February 2015. Overall the results support the construct validity of the Italian version of the APAIS for the population of women undergoing Breast Biopsy suggesting that the Italian version of APAIS can be useful to detect this clinically very relevant dimension.

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The number of clinical trials for Duchenne muscular dystrophy is increasing. Many trials require muscle biopsies, which involve an invasive surgical procedure. Little is known about short- and long-term impacts of muscle biopsies as perceived by patients and caregivers. Therefore a survey was held among patients and their caregivers who participated in trials involving muscle biopsies, in seven countries. Seventy-eight responses were received. Analysis revealed that many patients and parents had significant anxiety before the biopsy. The main concern of caregivers was the required general anaesthesia. In most cases biopsies caused pain and temporarily hampered daily activities. The main long-term impact was scarring, although large variation in size was reported. Seventy-nine percent of caregivers were little bothered and 21% were moderately or severely bothered by the scar. Willingness to consider another biopsy in future protocols was higher for open-label studies than for placebo-controlled trials. Caregivers stressed the importance of knowing the results of biopsy analyses; only a minority actually received this information. Recommendations are made on the informed consent procedure regarding risks and consequences of muscle biopsies, and communication of results. Furthermore, efforts should be made to minimise the impact of biopsies through pain management and by considering plastic surgery.

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BACKGROUND: Each year, over 1 million women in the USA undergo diagnostic breast biopsies, many of which culminate in a benign outcome. However, for many patients, the experience of awaiting biopsy results is far from benign, instead provoking high levels of distress. PURPOSE: To take a multifaceted approach to understanding the psychological experience of patients undergoing a breast biopsy. METHOD: Female patients (N = 214) were interviewed at an appointment for a breast biopsy, just prior to undergoing the biopsy procedure. Pertinent to the current investigation, the interview assessed various patient characteristics, subjective health and cancer history, support availability, outcome expectations, distress, and coping strategies. RESULTS: The findings revealed a complex set of interrelationships among patient characteristics, markers of distress, and use of coping strategies. Patients who were more distressed engaged in more avoidant coping strategies. Regarding the correlates of distress and coping, subjective health was more strongly associated with distress and coping than was cancer history; perceptions of support availability were also reliably associated with distress. CONCLUSION: Taken together, the results suggest that patients focus on their immediate experience (e.g., subjective health, feelings of risk, perceptions of support) in the face of the acute moment of uncertainty prompted by a biopsy procedure, relative to more distal considerations such as cancer history and demographic characteristics. These findings can guide clinicians' interactions with patients at the biopsy appointment and can serve as a foundation for interventions designed to reduce distress in this context.

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BACKGROUND: A multi-country, community-based trial on scheduled screening and treatment for malaria in pregnancy was conducted in Benin, The Gambia and Burkina Faso. Despite standardized procedures and outcomes, the study became subject to rumours and accusations of placenta being sold for mystical and financial gain by trial staff, leading to drop-out rates of 30% and the consequent halting of placental biopsy sampling in Benin. This paper explores the role of socio-cultural beliefs related to placenta and identified additional factors contributing these rumours. METHODS: A qualitative comparative emergent-theory design was used to assess social factors related to trial implementation and uptake in the three countries. Data from participant observation, informal conversations, group discussions and interviews were triangulated and analysed with NVivo Qualitative Analysis software. RESULTS: Despite similar sociocultural beliefs about the sacred nature of the placenta in all three study countries, these beliefs did not affect participation rates in Burkina Faso and The Gambia and placenta-related rumours only emerged in Benin. Therefore, the presence of beliefs is not a sufficient condition to have generated placenta-selling fears. The rumours in Benin reflected the confluence of placenta-related beliefs and factors related to the implementation of the trial (including a catalysing adverse event and miscommunication during the informed consent procedure). Furthermore, distinct socio-political factors contributed to the emergence of rumours, including the historical distrust in governmental organizations and the tense relationship between some of the actors involved in the trial. CONCLUSION: Transdisciplinary social science research designs should accompany the implementation of the trial. The integration of multiple stakeholders' knowledge and involvement is required to define and solve upcoming barriers.

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PURPOSE: Mindfulness-based programs can reduce stress and help practitioners to have positive attitudes in their daily lives. This randomized controlled trial evaluated the impact of brief Mindfulness interventions on quantitative and qualitative stress parameters in patients undergoing imaging-guided breast biopsies. METHODS: Eighty-two women undergoing percutaneous imaging-guided breast biopsy were randomized into two groups: MBI group or standard care group. One week before the biopsy procedure, on the waiting room and during the biopsy procedure, the MBI group was exposed to mindfulness techniques and the standard care group received supportive dialogue from the biopsy team. Participants completed questionnaires measuring depression, anxiety and stress, demographics, and medical history, besides evaluating their pain experience through a visual analogue scale for pain and had their systolic and diastolic blood pressure, initial and final temperate, heart rate, oxygen saturation, and salivary cortisol measured. RESULTS: Participation in the mindfulness intervention group was associated with reduced levels of perceived stress, blood pressure, heart rate, and oxygen saturation compared to participation in the standard care group (P values < 0.05). No difference was observed regarding salivary cortisol levels, peripheral temperature, and pain perception between the two studied groups. CONCLUSION: Results indicate that an extremely brief mindfulness intervention is a feasible intervention, suggesting that Mindfulness-based programs may be beneficial to reduce discomfort in acutely stressful settings.

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OBJECTIVES: To determine the effects of a virtual reality intervention on pain and anxiety in patients undergoing a bone marrow aspiration and biopsy procedure. SAMPLE & SETTING: 97 adults in an outpatient cancer center in the midwestern United States. METHODS & VARIABLES: In this quasiexperimental study, participants were assigned to either the experimental group (use of virtual reality goggles) or the control group (standard treatment). Vital signs, pain, and anxiety were measured before and after the procedure. T tests and chi-square tests were used to compare the two groups based on demographic data, pain, anxiety, and total amount of medication used during the procedure. RESULTS: Participants who wore virtual reality goggles during a bone marrow aspiration and biopsy procedure did not experience a statistically significant decrease in pain and anxiety. However, the experimental and control groups showed a decrease in pain and anxiety levels from pre- to postprocedure. IMPLICATIONS FOR NURSING: Virtual reality goggles may be a feasible, noninvasive alternative to traditional pharmacologic treatment. The cost of any intervention would need to be considered. Virtual reality should be researched and adapted to benefit patients in appropriate settings.

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BACKGROUND: Research biopsies (RBs) are essential to understanding tumor biology and mechanisms of resistance and to advancing precision medicine. However, RBs have associated risks and may not benefit the patient. OBJECTIVES: The purpose of this integrative review is to summarize and synthesize the current literature on the experience, attitudes, and understanding of patients with cancer related to RBs. METHODS: Articles from January 2010 to February 2017 were retrieved via a search of MEDLINE®. Articles included reported on the willingness, perceptions, understanding, attitudes, and/or experience of patients with cancer related to RBs. FINDINGS: Nine of 216 identified studies were selected. Studies exploring patient willingness to undergo RBs (n = 6) identified RBs as a potential barrier to clinical trial participation. Studies exploring patient understanding and informed consent (n = 3) revealed variable patient knowledge of the risks and benefits of RBs.

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PURPOSE: To determine women's perceptions of breast cancer risk and thresholds for desiring biopsy when considering BI-RADS 3 and 4A scenarios and recommendations, respectively. MATERIALS AND METHODS: Women presenting for screening mammography from five geographically diverse medical centers were surveyed. Demographic information and baseline anxiety were queried. Participants were presented with scenarios of short-term imaging follow-up recommendations (ie, BI-RADS 3) and biopsy recommendations (ie, BI-RADS 4A) for low-risk mammographic abnormalities and asked to estimate their breast cancer risk for each scenario. Participants reported the threshold (ie, likelihood of cancer) where they would feel comfortable undergoing short-term imaging follow-up and biopsy and their anticipated regret for choosing short-term follow-up versus biopsy. RESULTS: Analysis of 2,747 surveys showed that participants estimated breast cancer risk of 32.8% for a BI-RADS 3 and 41.1% for a BI-RADS 4A scenarios are significantly greater rates than clinically established rates (<2% [P < .001] and 2%-10% [P < .001], respectively). Over one-half (55.4%) of participants reported they would never want imaging follow-up if there was any chance of cancer; two-thirds (66.2%) reported they would desire biopsy if there was any chance of cancer. Participants reported greater anticipated regret (P < .001) and less relief and confidence (P < .001) with the decision to undergo follow-up imaging versus biopsy. CONCLUSION: Women overestimate breast cancer risk associated with both BI-RADS 3 and 4A scenarios and desire very low biopsy thresholds. Greater anticipated regret and less relief and confidence was reported with the choice to undergo short-term imaging follow-up compared with biopsy.

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AIM: This study aimed to evaluate the efficacy of music therapy for reducing the anxiety and pain of patients who underwent a biopsy. BACKGROUND: Music can affect human anxiety and pain by triggering a neuroendocrine effect. Clinical study results indicated that music can influence the anxiety and pain caused by invasive procedures. There is no effective solution for anxiety and pain arising from a biopsy. Although researchers in this field have different views, music still holds promise in reducing the anxiety and pain in patients undergoing the biopsy. DESIGN: Systematic review and meta-analysis of randomized controlled trials. DATA SOURCES: Systematic searches were conducted in PubMed, Embase, Medline and Cochrane databases for studies reported in the English language. The review period covered 2000 - December 2016. The outcome measure of interest was anxiety and pain. METHODS: This review followed Cochrane methods. Studies were selected according to the PICOS framework. The methodological quality of studies was assessed with the Cochrane risk of bias tool. A systematic review of effectiveness was conducted by using GRADE approach. RESULTS: Nine randomized controlled trials with a total of 326 participants in the music intervention group and 323 controls met the inclusion criteria. Music had a tendency towards decreasing systolic blood pressure before the biopsy, State-Trait Anxiety Inventory scores after the biopsy, diastolic blood pressure after the biopsy and heart rate after the biopsy. Similarly, music also tended to be more effective for controlling pain after the biopsy. There was moderate quality evidence for the outcome: State-Trait Anxiety Inventory scores after the biopsy; and low- or very low-quality evidence for other outcomes. CONCLUSION: Music can be used for patients before and during the biopsy procedure. This approach may be performed by nurses to promote the recovery of patients after the biopsy.

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PURPOSE: Evidence suggests open communication about breast cancer concerns promotes psychological adjustment, while holding back can lead to negative outcomes. Little is known about the relationship between communication and distress following breast biopsy. Design/ Sample: Women (N = 128) were assessed at the time of breast biopsy and again one week and three, six, and 12 months post-result. METHODS: Linear mixed modeling examined relationships between holding back and anxiety for women with benign results (n = 94) or DCIS/invasive disease (n = 34) following breast biopsy. FINDINGS: Anxiety increased among women with a benign result engaging in high but not low or average levels of holding back. Holding back was positively associated with anxiety post-result in breast cancer survivors, with anxiety decreasing over time. Conclusions/ Implications: Interventions to enhance communication are warranted, and knowledge of the differences among women with benign results and/or DCIS/invasive disease may allow for the development of tailored interventions.

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OBJECTIVE: Many men undergo prostate biopsies each year. Most data on consequences of prostate biopsy for men pertain to physical after-effects and/or come from clinical trial populations. We quantified prevalence of, and identified factors associated with, procedure-related distress in men having prostate biopsies in routine clinical practice. METHODS: Men who had undergone prostate biopsy for follow-up of a raised prostate specific antigen test result and/or abnormal digital rectal examination in 6 centres in Ireland completed questionnaires. Biopsy-related psychological distress was measured using the Impact of Event Scale. An Impact of Event Scale score ≥ 9 was considered significant biopsy-related distress. Logistic regression was used to identify predictors of significant distress. RESULTS: Three hundred thirty-five men completed questionnaires. Overall, 49% had significant biopsy-related distress; this was higher in men whose biopsy result indicated cancer (59%) and those who did not have a definitive result (54%) than those with a negative result (35%; P < .001). In multivariable analyses, the odds of significant distress were 3 times higher in men with cancer (OR = 3.33, 95% CI, 1.83-6.04) and more than twice as high in men without a definitive result (OR = 2.61, 95% CI, 1.43-4.78) compared to men with a negative result. Men with intermediate (OR = 3.19, 95% CI, 1.85-5.53) or high (OR = 7.10, 95% CI, 3.45-14.57) health anxiety (propensity to worry about one's health) also had significantly increased odds of biopsy-related distress. CONCLUSIONS: Significant distress is common after prostatic biopsy. Some men, including those who are highly health anxious and those awaiting definitive results, may benefit from additional support around the time of and/or following prostate biopsy.

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