The obesity paradox in metastatic castration-resistant prostate cancer.

OBJECTIVE: To test whether body mass index (BMI) amongst patients with metastatic castration-resistant prostate cancer (mCRPC) is associated with overall survival (OS) and cancer-specific survival. METHODS: Individual patient data from 1577 men with mCRPC treated with docetaxel and prednisone from the control arms of ASCENT2, VENICE, and MAINSAIL were considered. The role of BMI on survival outcomes was investigated both as a continuous and categorical variable (≤24.9 vs. 25-29.9 vs. ≥30 km/m2). BMI ≥ 30 kg/m2 was considered obese. Analyses were adjusted for age, PSA, ECOG performance status, number of metastases and prior treatment. The Cox semi-proportional hazard model was used to predict OS, whereas competing risks regression was used for predicting cancer-specific mortality (CSM). To exclude any possible effect attributable to higher doses of chemotherapy (titrated according to body-surface area), we checked for eventual interactions between BMI and chemotherapy dose (both as continuous-continuous and categorical-continuous interactions). RESULTS: The median (IQR) age for the patient population was 69 (63,74) years with a median (IQR) BMI of 28 (25-31) kg/m2. Median follow-up for survivors was 12 months. Of the 1577 patients included, 655 were deceased by the end of the studies. Regarding OS, BMI emerged as a protective factor both as a continuous variable (HR: 0.96; 95% CI: 0.94, 0.99; p = 0.015) and as a categorical variable (obesity: HR: 0.71, 95% CI: 0.53, 0.96; p = 0.027, relatively to normal weight). The protective effect of high BMI on CSM was confirmed both as a continuous (SHR: 0.94; 95% CI: 0.91, 0.98; p = 0.002) and as a categorical variable (obesity SHR: 0.65; 95% CI: 0.45, 0.93; p = 0.018). No interaction was detected between the BMI categories and the docetaxel dose at any level in our analyses (all p ¼ 0.05). CONCLUSIONS: Obese patients with mCRPC had better cancer-specific and overall survival as compared to overweight and normal weight patients. The protective effect of BMI was not related to receiving higher chemotherapy doses. Further studies aimed at elucidating the biological mechanism behind this effect are warranted.

COVID-19 in patients with and without cancer: Examining differences in patient characteristics and outcomes.

This study examines differences between patients with and without cancer in patient demographic and clinical characteristics and COVID-19 mortality and discusses the implications of these differences in relation to existing cancer disparities and COVID-19 vulnerabilities. Data was collected as a part of a retrospective study on a cohort of COVID-19 positive patients across Mount Sinai Health System from March 28, 2020 to April 26, 2020. Descriptive, comparative, and regression analyses were applied to examine differences between patients with and without cancer in demographic and clinical characteristics and COVID-19 mortality and whether cancer status predicts COVID-19 mortality controlling for these covariates using SAS 9.4. Results showed that, of 4641 patients who tested positive for COVID-19, 5.1% (N=236) had cancer. The median age of the total sample was 58 years (Q1-Q3: 41-71); 55.3% were male, 19.2% were current/former smokers, 6.1% were obese. The most commonly reported comorbidities were hypertension (22.6%) and diabetes (16.0%). Overall, the COVID-19 mortality rate was 8.3%. Examining differences between COVID-19 patients with and without cancer revealed significant differences (p<0.05) in COVID-19 mortality, hospitalization rates, age, gender, race, smoking status, obesity, and comorbidity indicators (e.g., diabetes) with cancer patients more likely to be older, male, black, obese, smokers, and with existing comorbidities. Controlling for these clinical, demographic, and behavioral characteristics, results of logistic regression analyses showed significant effects of older age and male gender on COVID-19 mortality (p<0.05). While cancer patients with COVID-19 were more likely to experience worse COVID-19 outcomes, these associations might be related to common cancer and COVID-19 vulnerability factors such as older age and gender. The coexistence of these vulnerability age and gender factors in both cancer and COVID-19 populations emphasizes the need for better understanding of their implications for cancer and COVID-19 disparities, both diseases prevention efforts, policies, and clinical management.

Dealing With the Unthinkable: Bladder and Colorectal Cancer Patients' and Informal Caregivers' Unmet Needs and Challenges in Life After Ostomies.

OBJECTIVES: We examined patient and informal caregiver unmet needs to identify areas for targeted supportive care interventions and programs to enhance both patient and informal caregiver experience. DATA SOURCES: A total of 30 patients who underwent ostomy surgeries for bladder or colorectal cancers and 13 informal caregivers participated in the study. Patients were enrolled at the Icahn School of Medicine at Mount Sinai between 2017 and 2018. Qualitative data were collected by individual interviews, audiotaped, and transcribed verbatim. Transcribed data were iteratively analyzed using Atlas.ti to explore patient and caregiver unmet needs. RESULTS: Patients and informal caregivers reported having insufficient psychological preparation for ostomy surgeries, and very limited hands-on training on stoma care and utility of stomal appliances. Unmet psychological needs related to depression, anxiety, and distress caused by changes in body image and sexual, urinary, and bowel function were reported. Patients and caregivers also reported significant patient medical needs in the acute postoperative period including pain, fatigue, sleep disturbance, inflammation, and complications resulting in hospital readmissions. Colorectal cancer patients specifically experienced significant challenges with changes in diet and nutrition that contributed to ostomy care burden. Both patients and caregivers recommended seeking psychological and social support to enhance both patient and caregiver emotional adjustment to life after ostomies. CONCLUSION: Meeting patient and informal caregiver unmet informational and supportive care needs is imperative to improve their quality of life and adjustment. IMPLICATIONS FOR NURSING PRACTICE: An effective supportive care plan should be designed and utilized in clinical care to improve ostomy patients' and caregivers' outcomes.

Identifying Distinct High Unmet-Need Phenotypes and Their Associated Bladder Cancer Patient Demographic, Clinical, Psychosocial, and Functional Characteristics: Results of Two Clustering Methods.

OBJECTIVES: We explored phenotypes of high unmet need of patients with bladder cancer and their associated patient demographic, clinical, psychosocial, and functional characteristics. DATA SOURCES: Patients (N=159) were recruited from the Bladder Cancer Advocacy Network and completed an online survey measuring unmet needs (BCNAS-32), quality of life (FACT-Bl), anxiety and depression (HADS), coping (BRIEF Cope), social support (SPS), and self-efficacy beliefs (GSE). Hierarchical agglomerative (HA) and partitioning clustering (PC) analyses were used to identify and confirm high unmet-need phenotypes and their associated patient characteristics. Results showed a two-cluster solution; a cluster of patients with high unmet needs (17% and 34%, respectively) and a cluster of patients with low-moderate unmet needs (83% and 66%, respectively). These two methods showed moderate agreement (κ=0.57) and no significant differences in patient demographic and clinical characteristics between the two groups. However, the high-need group identified by the HA clustering method had significantly higher psychological (81 vs 66, p < .05), health system (93 vs 74, p < .001), daily living (93 vs 74, P < .001), sexuality (97 vs 69, P < .001), logistics (84 vs 69, P < .001), and communication (90 vs 76, P < .001) needs. This group also had worse quality of life and emotional adjustment and lower personal and social resources (P < .001) compared with the group identified by the PC method. CONCLUSION: A significant proportion of patients with bladder cancer continues to have high unique but inter-related phenotypes of needs based on the HA clustering method. IMPLICATIONS FOR NURSING PRACTICE: Identifying characteristics of the most vulnerable patients will help tailor support programs to assist these patients with their unmet needs.

Development and evaluation of a bladder Cancer specific survivorship care plan by patients and clinical care providers: a multi-methods approach.

BACKGROUND, CONTEXT AND PURPOSE: In spite of the mixed evidence for their impact, survivorship Care Plans (SCPs) are recommended to enhance quality of care for cancer survivors. Data on the feasibility of SCPs in bladder cancer (BC) is sparse. Using a mixed-methods approach, this study describes the iterative development, acceptability and feasibility of BC specific SCP (BC-SCP) in clinical settings. METHODS: In Phase I, we developed the BC-SCP. In Phase II, we conducted four focus groups with 19 patients and 15 providers to examine its acceptability and usability challenges. Data analyses using the Atlas.ti program, informed refinement of the BC-SCP. In Phase III, we conducted feasibility testing of the refined BC-SCP with 18 providers from 12 health-centers. An encounter survey was completed after each assessment to examine the feasibility of the BC-SCP. Chi-square and Fisher Exact tests were used for comparative analyses. RESULTS: During phase I, we observed high patient and provider acceptability of the BC-SCP and substantial engagement in improving its content, design, and structure. In Phase II, providers completed 59 BC-SCPs. Mean time for BC-SCP completion was 12.3 min. Providers reported that BC-SCP content was clear, did not hamper clinic flow and was readily completed with easy-to-access information. Comparative analyses to examine differences in SCP completion time by patient clinico-demographic characteristics and provider type revealed no significant differences. CONCLUSIONS: Our BC-SCP has clinical relevance, and can be used in an active practice setting. However, considerable progress will be necessary to achieve implementation of and sharing the BC-SCP with patients and care providers, particularly within the electronic medical record. In summary, BC-SCPs are essential to improve the follow up care of BC survivors. Clinical resources are required to ensure appropriate implementation of BC-SCPs. TRIAL REGISTRATION: Study HUM00056082.

Involving Patients in the Development and Evaluation of an Educational and Training Experiential Intervention (ETEI) to Improve Muscle Invasive Bladder Cancer Treatment Decision-making and Post-operative Self-care: a Mixed Methods Approach.

This study aims to describe the acceptability and feasibility of an educational and training experiential intervention (ETEI) we developed to enhance muscle invasive bladder cancer (MIBC) patients with treatment decision-making and post-operative self-care. Twenty-five patients were randomized to a control group (N = 8) or ETEI group (N = 17). ETEI group participated in a nurse-led session on MIBC education. The control group received diet and nutrition education. Study questionnaires were completed at baseline and at 1-month post-intervention. Our results showed acceptable recruitment (58%) and retention rates (68%). The ETEI group reported increased knowledge (82% vs. 50%), improved decisional support (64% vs. 50%), improved communication (73% vs. 50%), and increased confidence in treatment decisions (73% vs. 50%) compared to the control group. Patients in the control group reported improved diet (50% v. 27%) as well as maintaining a healthy lifestyle (67% vs. 45%) compared to the ETEI group. Patients in the ETEI group reported a significant decrease in cancer worries and increases in self-efficacy beliefs over time compared to the control group. The ETEI was feasible, acceptable, and showed a potential for inducing desired changes in cancer worries and efficacy beliefs.

Clinical implications of prostatic capsular abutment or bulging on multiparametric magnetic resonance imaging.

BACKGROUND: The presence of capsular abutment or bulging can raise concern when planning surgery. In this study we aimed to test the clinical implications of capsular abutment or bulging on preoperative multiparametric magnetic resonance imaging (mpMRI). METHODS: We analyzed the data of 291 patients who underwent radical prostatectomy (RP) for a cT1-2N0 prostate cancer in a single surgeon series. All patients underwent preoperative staging with mpMRI. PIRADS v2 was used for characterizing lesions. The role of capsular abutment or bulging was tested in a multivariable logistic regression adjusting for prostate-specific antigen and highest ipsilateral biopsy Gleason grade. The presence of focal versus extensive extracapsular extension (ECE) was investigated. RESULTS: Overall, ECE on final pathology was documented in 35 (12%) cases and ECE was focal in 32 (91%) patients. Overall, mpMRI demonstrated capsule bulging or abutment in 12 (24%) cases. After adjusting for confounders, capsule bulging or abutment on mpMRI emerged as predictor for ECE (OR=6.70; 95% CI: 2.97-15.12, P<0.001). The sensitivity and specificity of capsule abutment or bulging in predicting ECE were 43% and 95%, respectively. Sensitivity and specificity were 36% and 48% respectively to predict focal ECE. CONCLUSIONS: The PIRADS v2 scoring system has a grey zone concerning ECE as defined by capsule abutment or bulging. We found an increased risk of ECE and specifically focal ECE when capsule bulging or abutment on mpMRI are documented.

Trends and outcomes in contemporary management renal cell carcinoma and vena cava thrombus.

INTRODUCTION: We sought to analyze the safety, efficacy, and national trends in the use of robotic radical nephrectomy (RN) and inferior vena cava thrombectomy in patients with renal cell carcinoma. PATIENTS AND METHODS: We analyzed 872 patients from the National Cancer Database dataset who underwent open (n = 838, 96.1%) or robotic (n = 34, 3.9%) radical nephrectomy with inferior vena cava thrombectomy for cT3b renal cell carcinoma between 2010 and 2014. Length of stay (LOS), 30-day readmissions and 30-day mortality were compared between the 2 groups. As internal validation, we performed a multi-institutional analysis of 20 patients (9 open [45%] vs. 11 robotic [55%]) undergoing RN with a level II thrombus. Patients were compared in terms of baseline characteristics, peri- and postoperative outcomes. Uni- and multivariable models were used adjusting for clinical and tumor characteristics. RESULTS: Baseline characteristics were similar between the 2 groups in both datasets. In the National Cancer Database, robotic approach was associated with 26% reduction in LOS (P < 0.001) but no difference in readmissions (odds ratio [OR] = 0.91; 95% confidence interval [CI] = 0.05, 4.50; P = 0.925) or 30-day mortality (OR = 2.72; 95% CI = 0.40, 10.86; P = 0.211). In multicenter database, open group had significantly greater blood loss (600 vs. 100.0 mL, P = 0.020). The rate of blood transfusion was higher in the open group, but was not significant (44.4% vs. 18.2%, P = 0.336). Robotic group had a shorter LOS (1 vs. 5 days; P = 0.026). No difference was seen between the open and robotic groups in terms of operative time (226 vs. 260 minutes, P = 0.922) and postoperative complications (P > 0.999). CONCLUSION: In select cases and experienced hands, robotic approach offers a reasonable alternative to open surgery without an increased complication rate.

Defining Prostate Cancer at Favorable Intermediate Risk: The Potential Utility of Magnetic Resonance Imaging and Genomic Tests.

PURPOSE: We determined whether prostate multiparametric magnetic resonance imaging and genomic biomarkers might help further define patients with favorable intermediate risk prostate cancer which could safely be considered suitable for active surveillance. MATERIALS AND METHODS: From our institutional database we identified 509 patients who underwent radical prostatectomy with preoperative magnetic resonance imaging and a postoperative Decipher® prostate cancer test. According to the NCCN® (National Comprehensive Cancer Network®) risk stratification 125 men had favorable intermediate and 171 had unfavorable intermediate risk disease. Univariable and multivariable binary logistic regression analyses were done to test the utility of different variables in predicting adverse pathology, defined as Gleason Grade Group greater than 2, pT3b or pN1. RESULTS: On univariable analysis favorable intermediate risk, multiparametric magnetic resonance imaging and the prostate cancer test significantly predicted adverse pathology. On multivariable analysis favorable intermediate risk and the prostate cancer test maintained independent predictive value while multiparametric magnetic resonance imaging did not meet statistical significance (p = 0.059). The 19 patients at favorable intermediate risk with high genomic risk had an adverse pathology rate slightly higher than patients at unfavorable intermediate risk (42.1% vs 39.8%, p = 0.56). Those at low genomic risk had an adverse pathology rate slightly lower than patients at very low or low risk (7.5% vs 10.2%, p = 0.84). The 31 patients at favorable intermediate risk but at high multiparametric magnetic resonance imaging and genomic risk had an adverse pathology rate slightly lower than patients at unfavorable intermediate risk (25.8% vs 39.8%, p = 0.14). Those at low multiparametric magnetic resonance imaging and genomic risk had an adverse pathology rate slightly lower than patients at very low or low risk (8.5% vs 10.2%, p = 0.89). CONCLUSIONS: Multiparametric magnetic resonance imaging and the Decipher test allowed us to better define the risk of adverse pathology in patients at favorable intermediate risk who were diagnosed with prostate cancer.

Knowledge of and Attitudes Towards Mental Illness Among ASHA and Anganwadi Workers in Vadodara District, Gujarat State, India.

Unmet needs in mental health care are high in low and middle-income countries like India. We propose recruiting community health workers (CHWs) to provide mental health services and address the treatment gap, but there is limited data available on the training needs for this potential role. The aim of this study is to help determine what type of formal mental health training and programming could most benefit CHWs in India. This was a cross sectional study design. Self-administered surveys were conducted amongst CHWs in the villages of Vadodara District, Gujarat, India. Statistical analyses included two tailed t-tests using Microsoft Excel 2011. The most common causes for mental illness were attributed to anxiety (61%) and brain disease (61%) followed by stress (45%) and alcohol use disorder (38%). CHWs were dismissive of faith healers ability to treat mental illness (72.9%) showing a strong approval for recommending psychiatric care for the mentally ill (84.4%). Over 50% of participants believed that mentally ill have a lower IQ and that they were unpredictable, but at the same time asserted that people with mental illness can live in the community (80.8%), and recover if given treatment and support (91.8%). Results are promising with CHWs displaying basic knowledge of the etiology and treatment of disease harboring positive attitudes towards psychiatrist's ability to treat mental illness. Future direction should focus on training CHWs towards minimizing stigmatizing views and increasing their knowledge of mental illness in order to scale up mental health services in these low resource communities.

A Comparison of Excisional Volume Loss Calculation Methods to Predict Functional Outcome After Partial Nephrectomy.

INTRODUCTION: Functional volume loss (FVL) is a significant predictor of kidney function decline after partial nephrectomy (PN). Here, we sought to assess two different methods for quantifying FVL post-PN: imaging-based tissue segmentation (TS) vs pathological analysis. METHODS AND RESULTS: From a single surgeon series, we performed a retrospective analysis of 42 patients who underwent PN for a cT1 renal mass between 2015 and 2017. The association between TS and pathological analysis at a median follow-up of 6 months (range: 3-9 months) was evaluated using Spearman's correlation. The association between pathological analysis, TS analysis, and estimated glomerular filtration rate (eGFR) decline at 6 months was evaluated using a multivariable linear mixed-effects models. For pathological analysis, dimensions of the specimen and tumor were extracted from pathology reports. FVL was calculated as [specimen volume (Length*Width*Height*π/6) - tumor volume (Length*Width*Height* π/6)]. For TS analysis, preoperative cross-sectional imaging was used (MRI n = 20; CT n = 22). FVL was calculated as [(overall kidney volume) - (tumor volume) - (cyst volume of renal cysts >1 cm)]. Postoperative functional volume was subtracted from preoperative functional volume to assess FVL post-PN for TS method. RESULTS: eGFR significantly decreased from baseline to postoperative 6 months (-5.1 mL/min/1.73 m2; p = 0.004). Even though there was a correlation between the two methods (coefficient = 0.245, p < 0.001), pathological analysis underestimated volume loss (32.2 mL vs 5.76 mL, p < 0.001). In multivariate linear regression analysis, TS analysis was significantly associated with a decline in eGFR (ß = 0.084, 95% CI = -0.02, 0.15; p = 0.012), whereas pathological analysis was not (ß = 0.02, 95% CI = -0.24, 0.28; p = 0.87). CONCLUSION: Pathological analysis underestimates parenchymal volume loss. Only imaging-based TS method is associated with change in eGFR post-PN.