Associations of self-efficacy, social support and coping strategies with health-related quality of life after radical cystectomy for bladder cancer: A cross-sectional study.

OBJECTIVES: Investigating associations between self-efficacy, social support and quality of life (HRQoL) and mediating effects of coping among bladder cancer (BC) patients treated with radical cystectomy (RC). METHODS: A cross-sectional study was conducted from January 2012 to December 2014 with 99 BC patients. An online survey assessed patient characteristics, HRQoL, coping strategies, self-efficacy and social support. A stepwise multiple linear regression model was used. RESULTS: Self-efficacy and social support were significantly associated with HRQoL. Complete mediation effects of adaptive/maladaptive coping strategies emerged for the associations between self-efficacy and social support with functional well-being (B = 0.247, 95% CI 0.119-0.374, p < 0.001; B = -0.414, 95% CI -0.526 to -0.302, p < 0.001) and total Functional Assessment of Cancer Therapy-Bladder (FACT-BI) (B = 0.779, 95% CI 0.351-1.207, p < 0.001; B = -1.969, 95% CI -2.344 to -1.594, p < 0.001). Maladaptive coping mediated the associations of self-efficacy and social support with physical well-being (B = -0.667, 95% CI -0.752 to -0.516, p < 0.001) and disease-specific symptoms (B = -0.413, 95% CI -0.521 to -0.304, p < 0.001). A partial mediation effect of adaptive coping was found for the association between self-efficacy and social well-being (B = 0.145, 95% CI 0.016-0.273, p < 0.05). Social support was significantly associated with emotional (B = 0.067, 95% CI 0.027-0.108, p < 0.001) and social well-being (B = 0.200, 95% CI 0.146-0.255, p < 0.001). CONCLUSION: Interventions should tackle self-efficacy, social support and coping strategies to improve BC patients' HRQoL.

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.

Patient-centered prioritization of bladder cancer research.

BACKGROUND: Patient-centered research requires the meaningful involvement of patients and caregivers throughout the research process. The objective of this study was to create a process for sustainable engagement for research prioritization within oncology. METHODS: From December 2014 to 2016, a network of engaged patients for research prioritization was created in partnership with the Bladder Cancer Advocacy Network (BCAN): the BCAN Patient Survey Network (PSN). The PSN leveraged an online bladder cancer community with additional recruitment through print advertisements and social media campaigns. Prioritized research questions were developed through a modified Delphi process and were iterated through multidisciplinary working groups and a repeat survey. RESULTS: In year 1 of the PSN, 354 patients and caregivers responded to the research prioritization survey; the number of responses increased to 1034 in year 2. The majority of respondents had non-muscle-invasive bladder cancer (NMIBC), and the mean time since diagnosis was 5 years. Stakeholder-identified questions for noninvasive, invasive, and metastatic disease were prioritized by the PSN. Free-text questions were sorted with thematic mapping. Several questions submitted by respondents were among the prioritized research questions. A final prioritized list of research questions was disseminated to various funding agencies, and a highly ranked NMIBC research question was included as a priority area in the 2017 Patient-Centered Outcomes Research Institute announcement of pragmatic trial funding. CONCLUSIONS: Patient engagement is needed to identify high-priority research questions in oncology. The BCAN PSN provides a successful example of an engagement infrastructure for annual research prioritization in bladder cancer. The creation of an engagement network sets the groundwork for additional phases of engagement, including design, conduct, and dissemination. Cancer 2018. © 2018 American Cancer Society.

Treatment of Non-Metastatic Muscle-Invasive Bladder Cancer: AUA/ASCO/ASTRO/SUO Guideline.

PURPOSE: This multidisciplinary, evidence-based guideline for clinically non-metastatic muscle-invasive bladder cancer focuses on the evaluation, treatment and surveillance of muscle-invasive bladder cancer guided toward curative intent. MATERIALS AND METHODS: A systematic review utilizing research from the Agency for Healthcare Research and Quality as well as additional supplementation by the authors and consultant methodologists was used to develop the guideline. Evidence-based statements were based on body of evidence strengths Grade A, B or C and were designated as Strong, Moderate and Conditional Recommendations with additional statements presented in the form of Clinical Principles or Expert Opinions. RESULTS: For the first time for any type of malignancy, the American Urological Association, American Society of Clinical Oncology, American Society for Radiation Oncology and Society of Urologic Oncology have formulated an evidence-based guideline based on a risk-stratified clinical framework for the management of muscle-invasive urothelial bladder cancer. This document is designed to be used in conjunction with the associated treatment algorithm. CONCLUSIONS: The intensity and scope of care for muscle-invasive bladder cancer should focus on the patient, disease and treatment response characteristics. This guideline attempts to improve a clinician's ability to evaluate and treat each patient, but higher quality evidence in future trials will be essential to improve level of care for these patients.

Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline.

PURPOSE: Although associated with an overall favorable survival rate, the heterogeneity of non-muscle invasive bladder cancer (NMIBC) affects patients' rates of recurrence and progression. Risk stratification should influence evaluation, treatment and surveillance. This guideline attempts to provide a clinical framework for the management of NMIBC. MATERIALS AND METHODS: A systematic review utilized research from the Agency for Healthcare Research and Quality (AHRQ) and additional supplementation by the authors and consultant methodologists. Evidence-based statements were based on body of evidence strength Grade A, B, or C and were designated as Strong, Moderate, and Conditional Recommendations with additional statements presented in the form of Clinical Principles or Expert Opinions.(1) RESULTS: A risk-stratified approach categorizes patients into broad groups of low-, intermediate-, and high-risk. Importantly, the evaluation and treatment algorithm takes into account tumor characteristics and uniquely considers a patient's response to therapy. The 38 statements vary in level of evidence, but none include Grade A evidence, and many were Grade C. CONCLUSION: The intensity and scope of care for NMIBC should focus on patient, disease, and treatment response characteristics. This guideline attempts to improve a clinician's ability to evaluate and treat each patient, but higher quality evidence in future trials will be essential to improve level of care for these patients.

Muscle invasive bladder cancer: examining survivor burden and unmet needs.

PURPOSE: Although improvements in perioperative care have decreased surgical morbidity after radical cystectomy for muscle invasive bladder cancer, treatment side effects still have a negative impact on patient quality of life. We examined unmet patient needs along the illness trajectory. MATERIALS AND METHODS: A total of 30 patients (26.7% women) treated with cystectomy and urinary diversion for muscle invasive bladder cancer participated in the study. Patients were recruited from the Department of Urology at Mount Sinai and through advertisements on the Bladder Cancer Advocacy Network (BCAN) website between December 2011 and September 2012. Data were collected at individual interviews, which were audiotaped and transcribed. Transcribed data were quantitatively analyzed to explore key unmet needs. RESULTS: At diagnosis unmet informational needs were predominant, consisting of insufficient discussion of certain topics, including urinary diversion options and their side effects, self-care, the recovery process and medical insurance. Unmet psychological needs related to depression, and worries about changes in body image and sexual function were reported. Postoperative unmet needs revolved around medical needs (eg pain and bowel dysfunction) and instrumental needs (eg need of support for stomal appliances, catheters and incontinence). During survivorship (ie 6 to 72 months postoperatively) unmet needs centered around psychological support (ie depression, poor body image and sexual dysfunction) and instrumental support (eg difficulty adjusting to changes in daily living). CONCLUSIONS: Meeting patient needs is imperative to ensure adequate patient involvement in health care and enhance postoperative quality of life. An effective support provision plan should follow changes in patient needs.

Critical analysis of contemporary clinical research in muscle-invasive and metastatic urothelial cancer: a report from the Bladder Cancer Advocacy Network Clinical Trials Working Group.

BACKGROUND: There have been no improvements in the treatment of metastatic urothelial cancer in the past several decades. A census of contemporary clinical research in this disease was performed to identify potential barriers and opportunities. METHODS: These authors performed a search for clinical trials exploring interventions in muscle-invasive and metastatic urothelial cancer, using the ClinicalTrials.gov registry. Data extracted from the registry included title, recruitment status, interventions, sponsor, phase, enrollment, study design, and study sites. RESULTS: Among 120 eligible trials exploring interventions in muscle-invasive and metastatic urothelial cancer, 73% were phase 2 and 73% were nonrandomized. The majority (63%) involved treatment in the metastatic disease state. The median planned enrollment size per trial was 45 patients (interquartile range, 47 patients). The majority of trials (55%) involved ≤ 3 study sites. Trials most commonly explored interventions in the first-line metastatic (30%) or second-line metastatic (37%) settings. Targeted therapeutics were studied in 58% of the trials. Among 56 trials that completed enrollment, the median time to complete accrual was 50 months (range, 10-109 months), and these trials enrolled a median of 40 patients per trial (interquartile range, 44 patients). CONCLUSIONS: The majority of contemporary clinical trials in muscle-invasive and metastatic urothelial cancer are small, nonrandomized, phase 2 trials involving 1 to 3 study sites. Enhanced communication and collaboration among the urothelial cancer community, and other stakeholders, is needed to facilitate the design and conduct of trials capable of expediting progress in this disease.

Depression and anxiety among patients treated for bladder cancer: examining clinical, demographic, and psychosocial predictors.

INTRODUCTION AND OBJECTIVE: The significant impact of bladder cancer and treatment on patient health related quality of life (HRQoL) and emotional wellbeing has been documented. Increasing evidence from cancer research emphasizes the importance of examining patients supportive care needs and received social support as factors that could influence their emotional adjustment. The purpose of the study was to assess the demographic and clinical predictors of depression and anxiety among bladder cancer patients and its associations with patient reported supportive care needs and perceived availability of social support. METHODS: A cross-sectional design was used to investigate the study questions. Bladder cancer patients were recruited from the Bladder Cancer Advocacy Network (BCAN) to complete a questionnaire that included the Hospital Anxiety and Depression Scale (HADS), bladder cancer patient need survey (BCNAS-32), and the social provisions scale (SPS). The inclusion criteria restricted our sample to include bladder cancer patients who were English speakers, aged 18-85 years, and were able and willing to provide informed consent. Patients who had metastatic disease, cancer recurrence, or other primary cancers at the time of assessment were excluded from the study. RESULTS: Participants included 159 bladder cancer patients. The mean age was 62±9.4 years and 51% were male. Almost two-thirds (62%) of patients reported a diagnosis of muscle invasive bladder cancer (MIBC), 25% patient reported clinically significant levels of anxiety, 17% reported clinically significant levels of depression, and 13% and 17% reported abnormal borderline abnormal levels for anxiety and depression, respectively. Univariate regression analyses revealed significant associations between HADS total score, HADS depression and anxiety subscales, patient age, physical functioning/daily living needs, sexuality needs, and perceived social support with higher total scores, anxiety, and depression scores associated with younger age, higher unmet needs, and lower levels of social support. Multivariate regression analyses, showed similar findings confirming the associations depicted by the univariate regression analyses. CONCLUSIONS: Bladder cancer patients experience significant levels of depression and anxiety and these levels are associated with patient age, supportive care unmet needs and lack of social support. Patient focused interventions could be tailored to address these issues with the goal to improve patient HRQoL and emotional adjustment.

Collaborative study from the Bladder Cancer Advocacy Network for the genomic analysis of metastatic urothelial cancer.

Urothelial Cancer - Genomic Analysis to Improve Patient Outcomes and Research (NCT02643043), UC-GENOME, is a genomic analysis and biospecimen repository study in 218 patients with metastatic urothelial carcinoma. Here we report on the primary outcome of the UC-GENOME-the proportion of subjects who received next generation sequencing (NGS) with treatment options-and present the initial genomic analyses and clinical correlates. 69.3% of subjects had potential treatment options, however only 5.0% received therapy based on NGS. We found an increased frequency of TP53E285K mutations as compared to non-metastatic cohorts and identified features associated with benefit to chemotherapy and immune checkpoint inhibition, including: Ba/Sq and Stroma-rich subtypes, APOBEC mutational signature (SBS13), and inflamed tumor immune phenotype. Finally, we derive a computational model incorporating both genomic and clinical features predictive of immune checkpoint inhibitor response. Future work will utilize the biospecimens alongside these foundational analyses toward a better understanding of urothelial carcinoma biology.

Future Directions in Bladder Cancer Treatment and Research-The Patient Advocates' Perspective.

Bladder cancer remains a deadly disease despite recent advances. Research advances should focus on improving quality of life for bladder cancer patients from time of initial diagnosis through end of life, with an emphasis on stratifying patients into appropriate risk categories and developing effective treatments to eliminate the need for bladder removal. Future research priorities should be prevention of disease, improved diagnostics, increased understanding of variant histologies and subgroups and targeting treatments, more effective therapies across disease states, advances in survivorship care to improve quality of life, improved access to clinical trials, and continued partnerships and multidisciplinary collaborations.

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.

Cancer patient advocacy: new opportunities for treatment advances.

Patient advocacy organizations play a critical role in increasing public awareness of a specific cancer and in demanding improvement in approaches to treatment. These organizations also can increase participation in clinical trials and help raise funds for research. But not all cancer patients are represented by advocacy organizations. Until the founding of the Bladder Cancer Advocacy Network in 2005, there was no patient advocacy group for bladder cancer despite the prevalence of the disease. Working with health care professionals, this new advocacy organization can facilitate further advances in research and treatment, leading possibly to a cure for bladder cancer.

Unmet informational and supportive care needs of patients following cystectomy for bladder cancer based on age, sex, and treatment choices.

PURPOSE: Assessing the unmet needs of cancer patients can help providers tailor health care services to patients' specific needs. This study examines whether the unmet informational and supportive care needs of the patients with muscle-invasive bladder cancer vary by the patients' age, sex, or individual treatment choices. METHODS AND MATERIALS: Participants (N = 30 survivors; 73.3% men) were recruited from the Mount Sinai Medical Center and through advertisements posted on a national Bladder Cancer Advocacy Network website between December 2011 and September 2012. Data were collected through individual interviews and electronic medical record review. A prior qualitative study of this cohort, using immersion/crystallization approach, confirmed the prevalence of unmet needs across the disease trajectory. This is a secondary quantitative analysis of the initial interview data we collected (i.e., quantitative analyses of transformed qualitative data using Chi-square and Fisher exact tests) to examine differences in unmet needs based on the patient's age, sex, and treatment choices. RESULTS: Younger patients (<60y) were less satisfied with the treatment information received presurgery and more likely to report posttreatment complications, choose a neobladder, and seek and receive professional support regarding sexual function, than were older patients (P<0.05). More women than men reported difficulties with self-care and relied on themselves in disease self-management as opposed to relying on spousal support (P<0.05). Patients with neobladder were more likely to report difficulties with urinary incontinence and deterioration in sexual function, whereas patients with ileal conduit were more likely to require spousal help with self-care. Patients who received chemotherapy were significantly more likely to report changes in everyday life (P<0.05). Lastly, regardless of age, sex, or treatment choice, up to 50% of patients reported feeling depressed before or after treatment. CONCLUSIONS: Unmet informational and supportive needs of patients with muscle-invasive bladder cancer during survivorship, and vary by age, sex, and treatment choices. Educational and psychological assessments as well as clinical interventions should be tailored to a patient's specific unmet needs, and to specific clinical and demographic characteristics.

Collaborating to Move Research Forward: Proceedings of the 10th Annual Bladder Cancer Think Tank.

The 10th Annual Bladder Cancer Think Tank was hosted by the Bladder Cancer Advocacy Network and brought together a multidisciplinary group of clinicians, researchers, representatives and Industry to advance bladder cancer research efforts. Think Tank expert panels, group discussions, and networking opportunities helped generate ideas and strengthen collaborations between researchers and physicians across disciplines and between institutions. Interactive panel discussions addressed a variety of timely issues: 1) data sharing, privacy and social media; 2) improving patient navigation through therapy; 3) promising developments in immunotherapy; 4) and moving bladder cancer research from bench to bedside. Lastly, early career researchers presented their bladder cancer studies and had opportunities to network with leading experts.

Summary and Recommendations from the National Cancer Institute's Clinical Trials Planning Meeting on Novel Therapeutics for Non-Muscle Invasive Bladder Cancer.

The NCI Bladder Cancer Task Force convened a Clinical Trials Planning Meeting (CTPM) Workshop focused on Novel Therapeutics for Non-Muscle Invasive Bladder Cancer (NMIBC). Meeting attendees included a broad and multi-disciplinary group of clinical and research stakeholders and included leaders from NCI, FDA, National Clinical Trials Network (NCTN), advocacy and the pharmaceutical and biotech industry. The meeting goals and objectives were to: 1) create a collaborative environment in which the greater bladder research community can pursue future optimally designed novel clinical trials focused on the theme of molecular targeted and immune-based therapies in NMIBC; 2) frame the clinical and translational questions that are of highest priority; and 3) develop two clinical trial designs focusing on immunotherapy and molecular targeted therapy. Despite successful development and implementation of large Phase II and Phase III trials in bladder and upper urinary tract cancers, there are no active and accruing trials in the NMIBC space within the NCTN. Disappointingly, there has been only one new FDA approved drug (Valrubicin) in any bladder cancer disease state since 1998. Although genomic-based data for bladder cancer are increasingly available, translating these discoveries into practice changing treatment is still to come. Recently, major efforts in defining the genomic characteristics of NMIBC have been achieved. Aligned with these data is the growing number of targeted therapy agents approved and/or in development in other organ site cancers and the multiple similarities of bladder cancer with molecular subtypes in these other cancers. Additionally, although bladder cancer is one of the more immunogenic tumors, some tumors have the ability to attenuate or eliminate host immune responses. Two trial concepts emerged from the meeting including a window of opportunity trial (Phase 0) testing an FGFR3 inhibitor and a second multi-arm multi-stage trial testing combinations of BCG or radiotherapy and immunomodulatory agents in patients who recur after induction BCG (BCG failure).

Bladder Cancer Patient Advocacy: A Global Perspective.

Over the past 20 years, cancer patient advocacy groups have demonstrated that patient engagement in cancer care is essential to improving patient quality of life and outcomes. Bladder cancer patient advocacy only began 10 years ago in the United States, but is now expanding around the globe with non-profit organizations established in Canada, the United Kingdom and Italy, and efforts underway in Australia. These organizations, at different levels of maturity, are raising awareness of bladder cancer and providing essential information and resources to bladder cancer patients and their families. The patient advocacy organizations are also helping to advance research efforts by funding research proposals and facilitating research collaborations. Strong partnerships between these patient advocates and the bladder cancer medical community are essential to ensuringsustainability for these advocacy organizations, increasing funding to support advances in bladder cancer treatment, and improving patient outcomes.

Summary of the 8th Annual Bladder Cancer Think Tank: Collaborating to move research forward.

OBJECTIVES: The 8th Annual Bladder Cancer Think Tank (BCAN-TT) brought together a multidisciplinary group of clinicians, researchers, and patient advocates in an effort to advance bladder cancer research. METHODS AND MATERIALS: With the theme of "Collaborating to Move Research Forward," the meeting included three panel presentations and seven small working groups. RESULTS: The panel presentations and interactive discussions focused on three main areas: gender disparities, sexual dysfunction, and targeting novel pathways in bladder cancer. Small working groups also met to identify projects for the upcoming year, including: (1) improving enrollment and quality of clinical trials; (2) collecting data from multiple institutions for future research; (3) evaluating patterns of care for non-muscle-invasive bladder cancer; (4) improving delivery of care for muscle-invasive disease; (5) improving quality of life for survivors; (6) addressing upper tract disease; and (7) examining the impact of health policy changes on research and treatment of bladder cancer. CONCLUSIONS: The goal of the BCAN-TT is to advance the care of patients with bladder cancer and to promote collaborative research throughout the year. The meeting provided ample opportunities for collaboration among clinicians from multiple disciplines, patients and patient advocates, and industry representatives.

Clinical trial design for the development of new therapies for nonmuscle-invasive bladder cancer: report of a Food and Drug Administration and American Urological Association public workshop.

OBJECTIVE: To summarize the discussion at a public workshop, cosponsored by the U.S. Food and Drug Administration (FDA) and the American Urological Association, reviewing potential trial designs for the development of new therapies for non-muscle-invasive bladder cancer (NMIBC). There have been only 3 drug approvals for NMIBC in the last 30 years, and product development for this disease has been stymied by difficulties in trial design and patient accrual. METHODS: A workshop evaluating potential trial design for the development of therapies for NMIBC was held in San Diego, CA, in May 2013. Invited experts representing all stakeholders, including urology, medical oncology, radiation oncology, industry, and patient advocates, discussed development of products for all risk strata of NMIBC. RESULTS: The panel responded to specific questions from the FDA, discussing eligibility criteria, efficacy endpoints, and trial design for patients with a mix of high-grade papillary disease and carcinoma in situ, Bacillus Calmette-Guerin (BCG)-refractory disease, and intermediate-risk disease. Panel members also addressed the magnitude of response that would be clinically meaningful for various disease strata and trial design options for perioperative intravesical chemotherapy instillation at the time of resection of bladder tumors. CONCLUSION: Expert commentary provided by panel members will inform a planned FDA guidance on pathways for drug and biologic development for NMIBC and will be discussed at meetings of the FDA's Oncologic Drugs Advisory Committee. FDA intends to develop a set of principles that can be used to promote the development of new products for this disease.