Impact of a clinical trial initiative on clinical trial enrollment in a multidisciplinary prostate cancer clinic.

Clinical oncology trials are hampered by low accrual rates, with fewer than 5% of adult patients with cancer treated on study. Clinical trial enrollment was evaluated at The University of Texas MD Anderson Cancer Center's Multidisciplinary Prostate Cancer Clinic (MPCC) to assess whether a clinical trial initiative, introduced in 2006, impacted enrollment. The trial initiative included posting trial-specific information in clinic, educating patients about appropriate clinical trial options during the treatment recommendation discussion, and providing patients with trial-specific educational information. The investigators evaluated the frequency of clinical trial enrollment for men with newly diagnosed prostate cancer seen in the MPCC from 2004 to 2008. Logistic regression evaluated the impact of patient characteristics and the clinical trial initiative on trial enrollment. The median age of the 1370 men was 64 years; 32% had low-risk, 49% had intermediate-risk, and 19% had high-risk disease. Overall, 74% enrolled in at least one trial and 29% enrolled in more than one trial. Trial enrollment increased from 39% before the initiative (127/326) to 84% (880/1044) after the trial initiative. Patient enrollment increased in laboratory studies (from 25% to 80%), quality-of-life studies (from 10% to 26%), and studies evaluating investigational treatments and systemic agents (from 6% to 15%) after the trial initiative. In multivariate analysis, younger men (P<.001) and men seen after implementation of the clinical trial initiative (P<.001) were more likely to enroll in trials. Clinical trial enrollment in the MPCC was substantially higher than that seen nationally in adult patients with cancer, and enrollment rates increased after the introduction of a clinical trial initiative.

The Role of the Advanced Practice Provider in Bone Health Management for the Prostate Cancer Population.

Androgen deprivation therapy (ADT) is standard, first-line therapy for many aspects of prostate cancer treatment. Although ADT can be an effective treatment to inhibit androgen-fueled cell growth in prostate cancer, suppressi.

Improving Quality and Cost of the Oncology Advanced Practice Provider Chemotherapy Privileging Process.

BACKGROUND: Managing antineoplastic orders, side effects, and symptoms is a primary role of oncology advanced practice providers (APPs). Antineoplastic management (ANM) is complex because of risk of medication errors, narrow therapeutic range of agents, frequent dose adjustments, and multiple drug regimens. OBJECTIVES: This article describes an academic institution's review of current practice for ANM privileging and employing Plan-Do-Study-Act (PDSA) cycles to develop a revised process relevant to APP practice, addressing efficiency, accessibility, and cost-effectiveness. METHODS: Using consecutive PDSA cycles, the team revised the didactic portion of the ANM privileging process and collaborated with nurses, pharmacists, and physicians for mentoring expertise. FINDINGS: The revised process resulted in increased relevance of ANM didactic content while requiring 75% less time to complete. To date, all ANM-privileged APPs at the institution (N = 49) have completed the revised ANM privileging process, with a 100% pass rate on the competency assessment.

Impact of Fasting on Patients With Cancer: An Integrative Review.

Background: Patients with cancer often pursue nutrition as an avenue to positively impact their care management and disease outcomes. Nutritional interventions are increasing in popularity, especially intermittent fasting as an adjunct to chemotherapy. However, limited research is available on the impact of intermittent fasting on patients with cancer. Methods: A comprehensive literature search was conducted using Ovid MEDLINE, Ovid EMBASE, and CINAHL databases. Results: 514 articles were identified from the three databases. Seven studies remained after applying inclusion and exclusion criteria. The seven studies included in this review examined fasting compliance, malnutrition, therapy side effects, endocrine parameters, quality of life measures, and cancer outcomes. Data suggest overall good compliance, no malnutrition, minimal side effects, a trend toward improved endocrine parameters, unchanged quality of life (QOL), and mixed results for cancer outcomes. Conclusion: Intermittent fasting as an adjunct to chemotherapy in normal-weight patients with cancer has potential as a safe, tolerable, and feasible nutritional intervention that could positively impact treatment outcomes and QOL. Large-scale randomized controlled trials are needed to validate these findings and determine what future role intermittent fasting may play in cancer management.

Are there differences in zonal distribution and tumor volume of prostate cancer in patients with a positive family history?

PURPOSE: To determine if there are any differences in the zonal distribution and tumor volumes of familial and sporadic prostate cancers (PC) in men undergoing radical prostatectomy. MATERIAL AND METHODS: 839 patients underwent a radical prostatectomy in the absence of prior neoadjuvant therapy between 1987 and 1996. Telephone interviews were conducted to obtain an updated family history. A positive family history was defined as the diagnosis of PC in at least one first degree relative. Prostatectomy specimens were examined to determine the number of tumor foci, zonal origin of the dominant tumor focus, tumor volume of the largest cancer focus, total tumor volume, Gleason score and stage, and the surgical margin status. Results were stratified according to family history and ethnicity. RESULTS: We successfully contacted 437 patients (52%). Prostatectomy specimens from 55 patients were excluded from review due to a history of prior transurethral resection of the prostate (n = 26) or uncertain pathological stage (n = 29). Of the remaining 382 patients, 76 (20%) reported having a first-degree relative with PC. Statistical analysis revealed no significant differences in the pathologic variables between the two groups of patients with or without a family history of PC. CONCLUSIONS: Familial and sporadic PC share similar characteristics. No histopathological differences account for the increased positive predictive value of PC screening tests among patients with a family history of PC.

Determining Clinically Based Factors Associated With Reclassification in the Pre-MRI Era using a Large Prospective Active Surveillance Cohort.

OBJECTIVE: To report biopsy-related and oncologic outcomes in a large prospective active surveillance cohort that was initiated in the premagnetic resonance imaging era and to additionally identify clinical factors associated with disease reclassification in order to inform future studies designed to improve enrollment and follow-up on active surveillance. METHODS: Patients were prospectively enrolled at a single institution from 2006 to 2014 and followed until 2016. Men with Gleason 6 or 7 disease were eligible, and those with >6 months follow-up were included in the analysis. Patients were risk stratified based on clinical/pathologic criteria, including based on a combination of baseline and confirmatory biopsy tumor characteristics. Reclassification-free survival, based on tumor volume increase or Gleason score increase, was analyzed using multivariable Cox proportional hazards models. RESULTS: Of 825 enrolled patients, 682 met inclusion criteria. Median follow-up was 40 months (range 6.6-126.8). Disease was reclassified in 249 (36.5%), and 157 (23.0%) underwent treatment. A single positive core with a negative confirmatory biopsy was significantly associated with time to reclassification (median not met vs 43 months, log rank test P <.001). Composite tumor length, defined as the combined tumor length between baseline and confirmatory biopsies, was associated with shorter Gleason upgrade-free survival (hazard ratio 1.24, 95% confidence interval 1.11-1.40, P <.001) in multivariable analysis. CONCLUSION: Baseline stratification using clinical factors including tumor length may refine risk stratification and offer the foundation on which new systems that incorporate modalities such as magnetic resonance imaging may be based.

Establishing an Individual Writing Practice.

Do you have a topic in mind for a manuscript but can't find the time or motivation to write it? This article provides step-by-step directions to encourage you to prioritize and plan your writing schedule.

Vaginal Testosterone for Management of Aromatase Inhibitor-Related Sexual Dysfunction: An Integrative Review.

PROBLEM IDENTIFICATION: Women taking aromatase inhibitors (AIs) as part of the management of hormone receptor-positive breast cancer experience more symptoms of sexual dysfunction, including vaginal atrophy, as opposed to postmenopausal women and women treated with tamoxifen (Nolvadex®). Vaginal testosterone could be an alternative to estrogen, which is contraindicated in this population.
. LITERATURE SEARCH: A systematic review was completed by searching PubMed and Scopus databases.
. DATA EVALUATION: 64 search results were reduced to a final sample of 3 articles after applying inclusion and exclusion criteria.
. SYNTHESIS: Published results suggest that vaginally applied testosterone doses of 150 mcg and 300 mcg improve symptoms of sexual dysfunction in women taking AIs. Minimal side effects are observed, and estradiol levels are not affected by vaginally applied testosterone. Additional research is needed to evaluate vaginal testosterone in women taking AIs.
. CONCLUSIONS: Vaginal testosterone shows preliminary promise as an option to manage sexual side effects of AI therapy in postmenopausal cancer survivors; however, available data are too limited to draw practice-changing conclusions.
. IMPLICATIONS FOR RESEARCH: Large-scale randomized, controlled trials need to be completed to evaluate the efficacy and safety of vaginal testosterone in women taking AIs.

Interventions to Manage Uncertainty and Fear of Recurrence in Female Breast Cancer Survivors: A Review of the Literature.

BACKGROUND: Fear of cancer recurrence (FCR) is one of the largest unmet needs in the breast cancer survivor population. This review addresses this unmet need with the question. OBJECTIVES: The purpose of this article is to better understand potential interventions to manage FCR when caring for breast cancer survivors. METHODS: Databases used were PubMed, CINAHL®, Google Scholar, EMBASE, and Scopus. Articles published in English from 2009-2014 with female breast cancer survivors and interventions that address FCR as an endpoint or outcome measure or objectively illustrate an improvement in FCR were included. One hundred ninety-eight articles were initially identified in this literature review search. Upon detailed review of content for relevance, seven articles met criteria to be included in this review. FINDINGS: This literature review provided current evidence of published interventions to manage uncertainty in the female breast cancer survivor population, as well as future research recommendations. Interventions surrounding being mindful, managing uncertainty, having more effective patient-provider communication, and handling stress through counseling are options for managing FCR.

Effectiveness of Granulocyte Transfusions in Neutropenic Adult Oncology Patients: A Comprehensive Review of the Literature.

Among patients with cancer, many factors can cause severe and persistent neutropenia, leading to increased morbidity and mortality. For patients with neutrophil deficiency, replacement with granulocyte transfusion (GTX) seems a rational approach. However, existing data on the efficacy of GTX have been inconclusive, and such adverse effects as respiratory distress and death indicate the need for further investigation into its efficacy. The purpose of this literature review was to address the question, "Are granulocyte transfusions effective in the management of adult oncology patients with neutropenia?" The focus was on adequate dosing, optimal timing of initiation, and adverse effects. Implications for practice for the provider and the niche population of neutropenic adult oncology patients that might benefit from GTX are presented.

Clinical Management of Bowel Dysfunction After Low Anterior Resection for Rectal Cancer.

The American Cancer Society estimated that 39,610 new cases of rectal cancer were diagnosed in the United States in 2015. Surgery is the primary treatment for rectal cancer, with the majority of patients undergoing sphincter-preserving surgery with low anterior resection. Although low anterior resection can prevent patients from having a permanent colostomy, bowel dysfunction may occur in 60% to 90% of patients. Bowel dysfunction symptoms may include fecal and gas incontinence, urgency, frequent bowel movements, clustering of stools, and difficulty emptying. The symptoms collectively are referred to as low anterior resection syndrome (LARS) and adversely affect quality of life. There are no specific therapies for management of LARS. This comprehensive literature review evaluates evidence-based, clinical nonsurgical interventions for symptom management of LARS and will assist advanced practitioners in recognizing symptoms and implementing clinical interventions in the outpatient setting for management of LARS.

Salvage cryotherapy for recurrent prostate cancer after radiotherapy: variables affecting patient outcome.

PURPOSE: To determine the long-term disease-specific survival (DSS) and disease-free survival (DFS) rates after salvage cryotherapy for locally recurrent adenocarcinoma of the prostate and to identify pretreatment factors that have an impact on DSS and DFS. PATIENTS AND METHODS: Between July 1992 and January 1995, 131 patients who had received definitive radiation therapy (XRT) underwent salvage cryotherapy for locally recurrent adenocarcinoma of the prostate. Cryotherapy failure was defined as an increasing postcryotherapy prostate-specific antigen (PSA) level of > or = 2 ng/mL above the postcryotherapy nadir, a positive prostate biopsy, or radiographic evidence of metastatic disease. Clinical variables were studied to determine whether there was an association with the DSS and DFS. RESULTS: The median follow-up was 4.8 years. The 5-year DSS rates were 87% for patients with a precryotherapy Gleason score < or = 8 and 63% for those with Gleason scores of 9 and 10 (P =.012). The 5-year DFS rates were 57% for patients with a precryotherapy PSA level of < or = 10 ng/mL and 23% for those with a PSA level greater than 10 ng/mL (P =.0004). The 5-year DSS rates for patients with a pre-XRT clinical stage of T1 to T2 and those with a clinical stage of T3 to T4 were 94% and 72%, respectively (P =.0041). The 5-year DFS rates for these groups were 90% and 69%, respectively (P =.0057). CONCLUSION: Androgen-independent local recurrences, Gleason score, and pre-XRT clinical stage were important factors that had an impact on DSS and DFS. The subset of patients cured by salvage cryotherapy seems to be small, and patient selection is important.

Hormone Replacement Therapy: An Increased Risk of Recurrence and Mortality for Breast Cancer Patients?

Historically, randomized controlled trials (RCTs) have shown an increased risk of recurrence and mortality among women who have used primarily oral HRT after breast cancer. However, many of these studies have had design flaws that may impact the findings. Numerous investigators have concluded that additional RCTs should be performed, but because of ethical issues and logistic challenges, large-scale RCTs are unlikely. Thus, the authors conducted an integrative review investigating recurrence and mortality data among breast cancer survivors who have used hormone replacement therapy (HRT). They recommend a stepwise algorithm for treating vaginal symptoms in breast cancer survivors: (1) start with nonhormonal treatments; (2) progress to a detailed discussion among patients and health-care professionals about the current known risks and benefits of vaginal estrogen; and (3) conclude with mutual decision-making between health-care providers and patients regarding the use of vaginal estrogen treatment.

The Toxicity and Benefit of Various Dosing Strategies for Interleukin-2 in Metastatic Melanoma and Renal Cell Carcinoma.

Interleukin-2 (IL-2) therapy has been used with success in curing meta-static renal cell carcinoma and melanoma in a small minority of patients. However, the benefits can be accompanied by severe toxicity. This review of the literature discusses varying doses of IL-2 and their associated re-sponse rates and the toxicities associated with treatment. The review also explores the maximally beneficial dose with the most tolerable side effects. Although the higher-dose regimens with a more frequent dosing schedule produce higher-grade toxicity, they were found to deliver the most durable and complete responses. It is recommended to use a higher-dose regimen (720,000 IU/kg every 8 hours for a maximum of 15 doses) and provide sup-portive care for toxicity, so patients can have maximal benefit from therapy.

A multidisciplinary prostate cancer clinic for newly diagnosed patients: developing the role of the advanced practice nurse.

Newly diagnosed patients with prostate cancer have various treatment options, and a multidisciplinary prostate cancer clinic (MPCC) can present all options in a single setting. An MPCC was started in 2004 at the University of Texas M.D. Anderson Cancer Center, and 258 patients with prostate cancer were evaluated in its first year. The clinic expanded in 2006 and an oncology advanced practice nurse (APN) was recruited to address specific objectives. The APN role was used to implement a quality-of-life protocol, provide detailed patient education (including a treatment summary and care plan), and serve as a single point of contact as patients move toward a treatment decision. Formal evaluation of the MPCC showed that patients were satisfied with this approach to the complex decision-making process in prostate cancer.

Randomized phase II trial evaluation of erectile function after attempted unilateral cavernous nerve-sparing retropubic radical prostatectomy with versus without unilateral sural nerve grafting for clinically localized prostate cancer.

BACKGROUND: Nonrandomized studies of unilateral nerve-sparing (UNS) radical prostatectomy (RP) have reported improved recovery of erectile function if the sacrificed cavernous nerve is reconstructed with a sural nerve graft (SNG). OBJECTIVE: To determine whether UNS RP plus SNG results in a 50% relative increase in potency at 2 yr compared to UNS RP alone. DESIGN, SETTING, AND PARTICIPANTS: The study enrolled patients from October 2001-May 2006 from a single academic center and was randomized, open label. Participants were men with localized prostate cancer recommended for UNS RP, less than 66 yr old, normal baseline erectile function, and willing to participate in early erectile dysfunction (ED) therapy. Patients were followed up to 2 yr. INTERVENTION: Patients underwent UNS RP and ED therapy starting at 6 wk: oral prostaglandin type-5 (PDE5) inhibitor, vacuum erection device (VED), and intracavernosal injection therapy. In the SNG group, a plastic surgeon performed the procedure at the time of RP. MEASUREMENTS: The ability to have an erection suitable for intercourse with or without a PDE5 inhibitor at 2 yr. The hypothesis was that SNG would result in a 60% potency rate compared to 40% for controls (80% power, 5% two-way significance). RESULTS AND LIMITATIONS: The trial planned to enroll 200 patients, but an interim analysis at 107 patients met criteria for futility and the trial was closed. For patients completing the protocol to 2 yr, potency was recovered in 32 of 45 (71%) of SNG and 14 of 21 (67%) of controls (p=0.777). By intent-to-treat analysis, potency recovered in 32 of 66 (48.5%) of SNG and 14 of 41 (34%) of controls (p=0.271). No differences were seen in time to potency or quality of life scores for ED and urinary function. Limitations included slower-than-expected accrual and poor compliance with ED therapy: <65% for VED and <40% for injections. CONCLUSIONS: The addition of SNG to a UNS RP did not improve potency at 2 yr following surgery. TRIAL REGISTRATION: ClinicalTrials.gov, Identifier: NCT00080808, http://www.clinicaltrials.gov/ct2/show/NCT00080808?term=NCT00080808&rank=1.