Quality of Life in Patients and Their Spouses and Cohabitating Partners in the Year Following a Cancer Biopsy (the Couples Cope Study): Protocol for a Prospective Observational Study.

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.

Transperineal Versus Transrectal Magnetic Resonance Imaging-targeted and Systematic Prostate Biopsy to Prevent Infectious Complications: The PREVENT Randomized Trial.

BACKGROUND AND OBJECTIVE: The transrectal biopsy approach is traditionally used to detect prostate cancer. An alternative transperineal approach is historically performed under general anesthesia, but recent advances enable transperineal biopsy to be performed under local anesthesia. We sought to compare infectious complications of transperineal biopsy without antibiotic prophylaxis versus transrectal biopsy with targeted prophylaxis. METHODS: We assigned biopsy-naïve participants to undergo transperineal biopsy without antibiotic prophylaxis versus transrectal biopsy with targeted prophylaxis (rectal culture screening for fluoroquinolone-resistant bacteria and antibiotic targeting to culture and sensitivity results) through a multicenter, randomized trial. The primary outcome was post-biopsy infection captured by a prospective medical review and patient report on a 7-d survey. The secondary outcomes included cancer detection, noninfectious complications, and a numerical rating scale (0-10) for biopsy-related pain and discomfort during and 7-d after biopsy. KEY FINDINGS AND LIMITATIONS: A total of 658 participants were randomized, with zero transperineal versus four (1.4%) transrectal biopsy infections (difference -1.4%; 95% confidence interval [CI] -3.2%, 0.3%; p = 0.059). The rates of other complications were very low and similar. Importantly, detection of clinically significant cancer was similar (53% transperineal vs 50% transrectal, adjusted difference 2.0%; 95% CI -6.0, 10). Participants in the transperineal arm experienced worse periprocedural pain (0.6 adjusted difference [0-10 scale], 95% CI 0.2, 0.9), but the effect was small and resolved by 7-d. CONCLUSIONS AND CLINICAL IMPLICATIONS: Office-based transperineal biopsy is tolerable, does not compromise cancer detection, and did not result in infectious complications. Transrectal biopsy with targeted prophylaxis achieved similar infection rates, but requires rectal cultures and careful attention to antibiotic selection and administration. Consideration of these factors and antibiotic stewardship should guide clinical decision-making. PATIENT SUMMARY: In this multicenter randomized trial, we compare prostate biopsy infectious complications for the transperineal versus transrectal approach. The absence of infectious complications with transperineal biopsy without the use of preventative antibiotics is noteworthy, but not significantly different from transrectal biopsy with targeted antibiotic prophylaxis.

Symptom burden profiles in men with advanced prostate cancer undergoing androgen deprivation therapy.

To identify symptom burden profiles among men with advanced prostate cancer undergoing androgen-deprivation therapy and examine their association with baseline sociodemographic and medical characteristics and psychosocial outcomes over time. Latent profile analysis was employed to identify distinct groups based on the Expanded Prostate Index Composite and the McGill Pain Questionnaire at baseline. Psychosocial outcomes were assessed at baseline, 6- and 12-month follow-ups. Three profiles emerged: "high symptom burden," "high sexual bother," and "low symptom burden." Men with "high symptom burden" were younger and exhibited higher baseline levels of depression, stress, cancer-specific distress, and anxiety than men in the other two groups. However, men with "high symptom burden" also demonstrated improvement in these psychosocial outcomes over time. Men with advanced prostate cancer who experience multiple co-occurring symptoms demonstrate worse psychosocial adjustment. Patients with substantial symptom burden, and specifically young men, may benefit from prompt referral to supportive care services.

Inflammatory bowel disease induces inflammatory and pre-neoplastic changes in the prostate.

BACKGROUND: Inflammatory bowel disease (IBD) has been implicated as a risk factor for prostate cancer, however, the mechanism of how IBD leads to prostate tumorigenesis is not known. Here, we investigated whether chronic intestinal inflammation leads to pro-inflammatory changes associated with tumorigenesis in the prostate. METHODS: Using clinical samples of men with IBD who underwent prostatectomy, we analyzed whether prostate tumors had differences in lymphocyte infiltrate compared to non-IBD controls. In a mouse model of chemically-induced intestinal inflammation, we investigated whether chronic intestinal inflammation could be transferred to the wild-type mouse prostate. In addition, mouse prostates were evaluated for activation of pro-oncogenic signaling and genomic instability. RESULTS: A higher proportion of men with IBD had T and B lymphocyte infiltration within prostate tumors. Mice with chronic colitis showed significant increases in prostatic CD45 + leukocyte infiltration and elevation of three pro-inflammatory cytokines-TIMP-1, CCL5, and CXCL1 and activation of AKT and NF-kB signaling pathways. Lastly, mice with chronic colitis had greater prostatic oxidative stress/DNA damage, and prostate epithelial cells had undergone cell cycle arrest. CONCLUSIONS: These data suggest chronic intestinal inflammation is associated with an inflammatory-rich, pro-tumorigenic prostatic phenotype which may explain how gut inflammation fosters prostate cancer development in men with IBD.

Impact of inflammatory bowel disease on radical prostatectomy outcomes and costs of care.

BACKGROUND: Recent studies suggest an association between prostate cancer and inflammatory bowel disease (IBD). Our objectives were to investigate clinical and financial impacts of IBD on radical prostatectomy (RP) and to determine the impact of surgical approach on our findings. METHODS: The Premier Hospital Database was queried for patients who underwent RP from 2003 to 2017. Multivariable logistic regression models were used to determine the independent impact of IBD on complications and readmission rates. We determined 90-day readmissions and examined 90-day hospital costs adjusted to 2019 US dollars with multivariable quantile regression models. RESULTS: Our study population included 262,189 men with prostate cancer, including 3,408 (1.3%) with IBD. There were higher odds for any complication for IBD patients compared with non-IBD controls for RP (15.64% vs. 10.66%). Patients with IBD had overall complication rates of 14.1% (P < 0.05) for open surgery and 17.2% for minimally invasive surgery (MIS) (P < 0.01). Between 2013 and 2017, the IBD cohort had significantly more complications (odds ratios (ORs): 2; 95% confidence interval (CI): 1.5 to 2.67; P < 0.0001), was more likely to have surgical costs in the top quartile (OR: 1.6; 95% CI: 1.23 to 2.1; P < 0.01), and had higher readmission rates (OR: 1.51; 95% CI: 1.1 to 2.06; P = 0.01). CONCLUSIONS: The IBD cohort who underwent MIS had the highest complication rates. Hospital readmissions and surgical costs were significantly higher for the IBD cohort who underwent RP between 2013 and 2017, when a minimally invasive approach was more prevalent than an open approach. These findings may be important when deciding which surgical approach to take when performing RP on men with IBD.

It's all in the name: Does nomenclature for indolent prostate cancer impact management and anxiety?

BACKGROUND: Despite consensus guidelines, many men with low-grade prostate cancer are not managed with active surveillance. Patient perception of the nomenclature used to describe low-grade prostate cancers may partly explain this discrepancy. METHODS: A randomized online survey was administered to men without a history of prostate cancer, presenting a hypothetical clinical scenario in which they are given a new diagnosis of low-grade prostate cancer. The authors determined whether diagnosis nomenclature was associated with management preference and diagnosis-related anxiety using ratings given on a scale from 1 to 100, adjusting for participant characteristics through multivariable linear regression. RESULTS: The survey was completed by 718 men. Compared with Gleason 6 out of 10 prostate cancer, the term grade group 1 out of 5 prostate cancer was associated with lower preference for immediate treatment versus active surveillance (ß = -9.3; 95% CI, -14.4, -4.2; P < .001), lower diagnosis-related anxiety (ß = -8.3; 95% CI, -12.8, -3.8; P < .001), and lower perceived disease severity (ß = -12.3; 95% CI, -16.5, -8.1; P < .001) at the time of initial diagnosis. Differences decreased as participants received more disease-specific education. Indolent lesion of epithelial origin, a suggested alternative term for indolent tumors, was not associated with differences in anxiety or preference for active surveillance. CONCLUSIONS: Within a hypothetical clinical scenario, nomenclature for low-grade prostate cancer affects initial perception of the disease and may alter subsequent decision making, including preference for active surveillance. Disease-specific education reduces the differential impact of nomenclature use, reaffirming the importance of comprehensive counseling and clear communication between the clinician and patient.

Effects of web-based cognitive behavioral stress management and health promotion interventions on neuroendocrine and inflammatory markers in men with advanced prostate cancer: A randomized controlled trial.

Cognitive behavioral stress management (CBSM) improves quality of life and mitigates stress biology in patients with early-stage cancer, including men with localized prostate cancer. However, treatments for advanced prostate cancer like androgen deprivation therapy (ADT) can lead to significant symptom burden that may be further exacerbated by stress-induced inflammation and cortisol dysregulation. The aim of this study was to examine the effects of CBSM (versus an active health promotion control) on circulating inflammatory markers and cortisol in men with advanced prostate cancer. METHODS: Men with stage III or IV prostate cancer (N = 192) who had undergone ADT within the last year were randomized to CBSM or health promotion. Both interventions were 10 weeks, group-based, and delivered online. Venous blood was drawn at baseline, 6 months, and 12 months to measure circulating levels of CRP, IL-6, IL-8, IL-10, and TNF-α. Saliva samples were collected at awakening, 30 min after awakening, evening, and night for two consecutive days at baseline, 6-months, and 12-months to measure diurnal cortisol slopes. RESULTS: Mixed modeling analyses demonstrated that changes in inflammatory markers and cortisol did not differ by intervention. Men in both CBSM and health promotion showed decreases in IL-10, IL-8, and TNF-α from baseline to 6 months (ß = -3.85--5.04, p's = 0.004-<0.001). However, these markers generally demonstrated a rebound increase from 6 to 12 months (ß = 1.91-4.06, p's = 0.06-<0.001). Men in health promotion also demonstrated a flatter diurnal cortisol slope versus men in CBSM at 6 months (ß = -2.27, p = .023), but not at 12 months. There were no intervention effects on CRP, IL-6, or overall cortisol output. CONCLUSIONS: Contrary to hypotheses, CBSM did not lead to changes in the circulating inflammatory markers and cortisol relative to health promotion. CBSM may be associated with healthy diurnal cortisol rhythm because of its focus on cognitive behavioral approaches to stress management. More research is needed to understand the impact of CBSM and health promotion on biomarkers among men with advanced prostate cancer.

Insurance coverage, stage at diagnosis, and time to treatment following dependent coverage and Medicaid expansion for men with testicular cancer.

INTRODUCTION: We sought to assess the impact of Affordable Care Act Dependent Care Expansion (ACA-DCE), which allowed dependent coverage for adults aged 19-25, and Medicaid expansion on outcomes for men with testicular cancer. METHODS: Using a US-based cancer registry, we performed adjusted difference-in-difference (DID) analyses comparing outcomes between men aged 19-25 (n = 8,026) and 26-64 (n = 33,303) pre- (2007-2009) and post-ACA-DCE (2011-2016) and between men in states that expanded Medicaid (n = 2,296) to men in those that did not (n = 2,265)pre- (2011-2013) and post-Medicaid expansion (2015-2016). RESULTS: In ACA-DCE analysis, rates of uninsurance decreased (DID -5.64, 95% confidence interval [CI] -7.23 to -4.04%, p<0.001) among patients aged 19-25 relative to older patients aged 26-64. There was no significant DID in advanced stage at diagnosis (stage≥II; p = 0.6) or orchiectomy more than 14 days after diagnosis (p = 0.6). For patients who received chemotherapy or radiotherapy as their first course of treatment, treatment greater than 60 days after diagnosis decreased (DID -4.84%, 95% CI -8.22 to -1.45%, p = 0.005) among patients aged 19-25 relative to patients aged 26-64. In Medicaid expansion states, rates of uninsurance decreased (DID -4.20%, 95% CI -7.67 to -0.73%, p = 0.018) while patients receiving chemotherapy or radiotherapy greater than 60 days after diagnosis decreased (DID -8.76, 95% CI -17.13 to -0.38%, p = 0.040) compared to rates in non-expansion states. No significant DIDs were seen for stage (p = 0.8) or time to orchiectomy (p = 0.1). CONCLUSIONS: Men with testicular cancer had lower uninsurance rates and decreased time to delivery of chemotherapy or radiotherapy following ACA-DCE and Medicaid expansions. Time to orchiectomy and stage at diagnosis did not change following either insurance expansion.

Association between inflammatory bowel disease and prostate cancer: A large-scale, prospective, population-based study.

Inflammatory bowel disease (IBD) is an established risk factor for colorectal cancer. Recent reports suggesting IBD is also a risk factor for prostate cancer (PC) require further investigation. We studied 218 084 men in the population-based UK Biobank cohort, aged 40 to 69 at study entry between 2006 and 2010, with follow-up through mid-2015. We assessed the association between IBD and subsequent PC using multivariable Cox regression analyses, adjusting for age at assessment, ethnic group, UK region, smoking status, alcohol drinking frequency, body mass index, Townsend Deprivation Index, family history of PC and previous prostate-specific antigen testing. Mean age at study entry was 56 years, 94% of the men were white, and 1.1% (n = 2311) had a diagnosis of IBD. After a median follow-up of 78 months, men with IBD had an increased risk of PC (adjusted hazard ratio [aHR] = 1.31, 95% confidence interval [CI] = 1.03-1.67, P = .029). The association with PC was only among men with the ulcerative colitis (UC; aHR = 1.47, 95% CI = 1.11-1.95, P = .0070), and not Crohn's disease (aHR 1.06, 95% CI = 0.63-1.80, P = .82). Results are limited by lack of data on frequency of health care interactions. In a large-scale, prospective cohort study, we detected an association between IBD, and UC specifically, with incident PC diagnosis.

Successful Resection of a Retrohepatic Inferior Vena Cava Primary Leiomyosarcoma with Atrial Thrombus Extension in a 30-Week Pregnant Woman.

Leiomyosarcomas are an uncommon malignant subset of tumors accounting for approximately 20% of soft tissue sarcomas. Primary vascular leiomyosarcomas (PVLs) are a rare subset of leiomyosarcomas that may originate in the arterial or venous circulation but most commonly affect the inferior vena cava (IVC). PVLs more commonly affect women to men in a 2:1 ratio and most frequently occur in the fourth to sixth decades of life. Few reports have described this infrequent pathologic state in the setting of advanced pregnancy. Presented is a case of a 44-year-old 30-week pregnant woman who presented with a PVL of the retrohepatic IVC, which was complicated by occlusion of the IVC and tumor thrombus extension into the hepatic veins and right atrium. Herein, we describe our multidisciplinary management of this rare problem with successful surgical resection of her tumor and IVC reconstruction.

Medicaid Expansion Did not Improve Time to Treatment for Young Patients With Metastatic Renal Cell Carcinoma.

INTRODUCTION: The absence of health insurance coverage has been associated with worse outcomes for patients with metastatic renal cell carcinoma (mRCC). Medicaid expansion in the United States was an important provision of the Affordable Care Act, which increased the number of low-income individuals eligible for Medicaid starting in January 2014 in several states. The effect of Medicaid expansion on access to healthcare for patients with mRCC is unknown. MATERIALS AND METHODS: We performed a retrospective cohort study of 6844 patients aged < 65 years with mRCC at diagnosis within the National Cancer Database. We compared the time to treatment and the rates of no insurance before (2012-2013) and after (2015-2016) expansion between patients living in states that had and had not expanded Medicaid using difference-in-difference (DID) analyses. DIDs were calculated using linear regression analysis with adjustment for sociodemographic covariates. RESULTS: The rate of no insurance did not change in the expansion states compared with the nonexpansion states (DID, -0.55%; 95% confidence interval, -3.32% to 2.21%; P = .7). The percentage of patients receiving treatment within 60 days of diagnosis had increased in the expansion states from 43% to 49% and in the nonexpansion states from 42% to 46% after expansion. No change was found in treatment within 60 days of diagnosis among all patients (DID, 2.81%; 95% confidence interval, -2.61% to 8.22%; P = .3). CONCLUSIONS: Medicaid expansion was not associated with improved healthcare access for patients with mRCC as reflected by timely treatment. Future work should assess the association between Medicaid expansion and oncologic outcomes.

First presentation of a scrotal glomus tumor in an adolescent male: A case report.

Glomus tumor of the scrotal skin is an extremely rare diagnosis in adult men with only five previous cases reported in the literature. We report the case of a 19-year-old man who was diagnosed with a glomus tumor following the surgical removal of a painful scrotal lesion, and further discuss the diagnosis and treatment of scrotal glomus tumors.

Technology-Based Psychosocial Intervention to Improve Quality of Life and Reduce Symptom Burden in Men with Advanced Prostate Cancer: Results from a Randomized Controlled Trial.

BACKGROUND: Men with advanced prostate cancer (APC) face multiple challenges including poor prognosis, poor health-related quality of life (HRQOL), and elevated symptom burden. This study sought to establish the efficacy of a tablet-delivered, group-based psychosocial intervention for improving HRQOL and reducing symptom burden in men with APC. We hypothesized that men randomized to cognitive-behavioral stress management (CBSM) would report improved HRQOL and reduced symptom burden relative to men randomized to an active control health promotion (HP) condition. Condition effects on intervention targets and moderators of these effects were explored. METHODS: Men with APC (N = 192) were randomized (1:1) to 10-week tablet-delivered CBSM or HP, and followed for 1 year. Multilevel modeling was used to evaluate condition effects over time. RESULTS: Changes in HRQOL and symptom burden did not differ between groups. Men in both groups improved across several intervention targets; men in the CBSM condition reported greater increases in self-reported ability to relax, and both conditions showed improvements in cancer-related anxiety, cancer-related distress, and feelings of cohesiveness with other patients over time. Moderating factors included baseline interpersonal disruption, fatigue, and sexual functioning. CONCLUSIONS: Tablet-delivered CBSM and HP were well received by men with APC. The hypothesized effects of CBSM on HRQOL and symptom burden were not supported, though improvements in intervention targets were observed across conditions. Participants reported high-baseline HRQOL relative to cancer and general population norms, possibly limiting intervention effects. The identified moderating factors should be considered in the development and implementation of interventions targeting HRQOL and symptom burden. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03149185.

Integrating PROMIS® computerized adaptive tests into a web-based intervention for prostate cancer.

OBJECTIVE: This study outlined the implementation and feasibility of delivering PROMIS® computer adaptive tests (CATs) using a web-based method to evaluate the impact of a technological adaptation of Cognitive-Behavioral Stress Management (CBSM) on the psychosocial functioning of men with advanced prostate cancer (APC) undergoing hormone therapy. METHOD: Patients were randomized to a CBSM group intervention (n = 95) or a health promotion (HP) attention-matched control condition (n = 97). Participants attended all sessions via video conference using tablets, and completed PROMIS® computer adaptive tests (CATs) assessing anxiety, depression, fatigue, pain interference, and physical function weekly during the 10-week intervention. RESULTS: Assessment completion rates >50% at week 1 and week 10 demonstrated moderate feasibility of repeatedly administering PROMIS® CATs using a web-based method. Multilevel modeling demonstrated no significant group-by-time interactions from week 1 to week 10 for any of the assessed PROMIS® domains adjusting for sociodemographic and medical covariates. However, simple effects demonstrated decreases in PROMIS® anxiety scores from week 1 to 10 for both groups. Results also demonstrated significant relationships of medical variables to psychosocial functioning across time points. CONCLUSIONS: Results highlight the feasibility and benefits of utilizing PROMIS® CATs to repeatedly assess psychosocial functioning using a web-based method and indicate that web-based interventions may be effective for decreasing psychosocial distress and adverse symptoms among men with APC undergoing hormone therapy. (PsycINFO Database Record (c) 2019 APA, all rights reserved).