Implementation Readiness and Initial Effects of a Brief Mindfulness Audio Intervention Compared With a Brief Music Control During Daily Radiation Therapy for Prostate Cancer: A Randomized Pilot Study.

Background: The most common and debilitating side effects of radiation therapy (RT) for prostate cancer (PC) are fatigue, sleep disturbance, anxiety, and depression. Previous research has reported palliative benefits from certain self-management approaches, such as mindfulness meditation. Objective: To develop, pre-test, and evaluate the feasibility, acceptability and initial benefit of brief, audio-based mindfulness delivered during daily RT for PC compared to a relaxing music control. Methods: Following intervention development, participants were randomized to either brief guided mindfulness audio recordings or a relaxing music control during daily RT. A pre-testing phase was first conducted to determine optimal program start time, length, and content most associated with retention. A final program (n = 26) was delivered daily, starting on day one of week 2 of RT and lasting 4 consecutive weeks. Feasibility was defined as ≥70% on enrollment rate, retention, and audio program adherence. Acceptability was measured with a 12-item post-study survey. A secondary focus compared between group changes on patient reported outcomes of fatigue, anxiety, depression, sleep disturbance, and related outcomes at baseline and follow up assessments. Descriptive statistics and general linear models were used. Results: Overall, 76% (n = 38) of approached men enrolled. Pre-testing retention rates were <70% while the final program's retention rate was 89%. The majority of acceptability criteria were met in both conditions, with relatively higher ratings in the mindfulness arm. Compared to music controls, mindfulness participants demonstrated significantly less uncertainty intolerance at 4-weeks (P = .046, d = .95); and significantly lower fatigue scores (P = .049, d = 1.3) and lower sleep disturbance scores (P = .035, d = 1.1) at the 3 months follow up. Conclusion: The final intervention met feasibility and acceptability criteria. Pre-testing refinements played a key role for optimal program delivery and retention. Audio-based mindfulness delivered during RT for PC hold potential to help decrease RT-related physical and emotional side effects.

Fluorescent reporter transgenic mice for in vivo live imaging of angiogenesis and lymphangiogenesis.

The study of lymphangiogenesis is an emerging science that has revealed the lymphatic system as a central player in many pathological conditions including cancer metastasis, lymphedema, and organ graft rejection. A thorough understanding of the mechanisms of lymphatic growth will play a key role in the development of therapeutic strategies against these conditions. Despite the known potential of this field, the study of lymphatics has historically lagged behind that of hemangiogenesis. Until recently, significant strides in lymphatic studies were impeded by a lack of lymphatic-specific markers and suitable experimental models compared to those of the more immediately visible blood vasculature. Lymphangiogenesis has also been shown to be a key phenomenon in developmental biological processes, such as cell proliferation, guided migration, differentiation, and cell-to-cell communication, making lymphatic-specific visualization techniques highly desirable and desperately needed. Imaging modalities including immunohistochemistry and in situ hybridization are limited by the need to sacrifice animal models for tissue harvesting at every experimental time point. Moreover, the processes of mounting and staining harvested tissues may introduce artifacts that can confound results. These traditional methods for investigating lymphatic and blood vasculature are associated with several problems including animal variability (e.g., between mice) when replicating lymphatic growth environments and the cost concerns of prolonged, labor-intensive studies, all of which complicate the study of dynamic lymphatic processes. With the discovery of lymphatic-specific markers, researchers have been able to develop several lymphatic and blood vessel-specific, promoter-driven, fluorescent-reporter transgenic mice for visualization of lymphatics in vivo and in vitro. For instance, GFP, mOrange, tdTomato, and other fluorescent proteins can be expressed under control of a lymphatic-specific marker like Prospero-related homeobox 1 (Prox1), which is a highly conserved transcription factor for determining embryonic organogenesis in vertebrates that is implicated in lymphangiogenesis as well as several human cancers. Importantly, Prox1-null mouse embryos develop without lymphatic vessels. In human adults, Prox1 maintains lymphatic endothelial cells and upregulates proteins associated with lymphangiogenesis (e.g., VEGFR-3) and downregulates angiogenesis-associated gene expression (e.g., STAT6). To visualize lymphatic development in the context of angiogenesis, dual fluorescent-transgenic reporters, like Prox1-GFP/Flt1-DsRed mice, have been bred to characterize lymphatic and blood vessels simultaneously in vivo. In this review, we discuss the trends in lymphatic visualization and the potential usage of transgenic breeds in hemangiogenesis and lymphangiogenesis research to understand spatial and temporal correlations between vascular development and pathological progression.

Cost-effectiveness of the School-Based Asthma Therapy (SBAT) program.

BACKGROUND AND OBJECTIVE: Impoverished urban children suffer disproportionately from asthma and underuse preventive asthma medications. The objective of this study was to examine cost-effectiveness (CE) of the School-Based Asthma Therapy (SBAT) program compared with usual care (UC). METHODS: The analysis was based on the SBAT trial, including 525 children aged 3 to 10 years attending urban preschool or elementary school who were randomized to either UC or administration of 1 dose of preventive asthma medication at school by the school nurse each school day. The primary outcome was the mean number of symptom-free days (SFDs). The impact of the intervention on medical costs was estimated by using parent-reported child health services utilization data and average national reimbursement rates. We estimated the cost of running the program using wages for program staff. Productivity costs were estimated by using value of parent lost time due to child illness. CE of the SBAT program compared with UC was evaluated based on the incremental CE ratio. RESULTS: The health benefit of the intervention was equal to ∼158 SFD gained per each 30-day period (P < .05) per 100 children. The programmatic expenses summed to an extra $4822 per 100 children per month. The net saving due to the intervention (reduction in medical costs and parental productivity, and improvement in school attendance) was $3240, resulting in the incremental cost-savings difference of $1583 and CE of $10 per 1 extra SFD gained. CONCLUSIONS: The SBAT was effective and cost-effective in reducing symptoms in urban children with asthma compared with other existing programs.

The school-based preventive asthma care trial: results of a pilot study.

OBJECTIVE: To test the feasibility and preliminary effectiveness of the School-Based Preventive Asthma Care Technology (SB-PACT) program, which includes directly observed therapy of preventive asthma medications in school facilitated by Web-based technology for systematic symptom screening, electronic report generation, and medication authorization from providers. STUDY DESIGN: We conducted a pilot randomized trial of SB-PACT versus usual care with 100 children (aged 3-10 years) from 19 inner-city schools in Rochester, New York. Outcomes were assessed longitudinally by blinded interviewers. Analyses included bivariate statistics and linear regression models, adjusting for baseline symptoms. RESULTS: There were data for 99 subjects for analysis. We screened all children using the Web-based system, and 44 of 49 treatment group children received directly observed therapy as authorized by their providers. Treatment group children received preventive medications 98% of the time they were in school. Over the school year, children in the treatment group experienced nearly 1 additional symptom-free day over 2 weeks versus the usual care group (11.33 vs 10.40, P = .13). Treatment children also experienced fewer nights with symptoms (1.68 vs 2.20, P = .02), days requiring rescue medications (1.66 vs 2.44, P = .01), and days absent from school due to asthma (0.37 vs 0.85, P = .03) compared with usual care. Further, treatment children had a greater decrease in exhaled nitric oxide (-9.62 vs -0.39, P = .03), suggesting reduction in airway inflammation. CONCLUSION: The SB-PACT intervention demonstrated feasibility and improved outcomes across multiple measures in this pilot study. Future work will focus on further integration of preventive care delivery across community and primary care systems.

Working toward a sustainable system of asthma care: development of the School-Based Preventive Asthma Care Technology (SB-PACT) trial.

OBJECTIVE: We previously conducted the School-Based Asthma Therapy trial to improve adherence to national asthma guidelines for urban children through directly observed administration of preventive asthma medications in school. The trial successfully improved outcomes among these children; however, several factors limit its potential for dissemination. To enhance sustainability, we subsequently developed a new model of care using web-based guides for efficient communications and integration within school and community systems. This article describes the development of the School-Based Preventive Asthma Care Technology (SB-PACT) trial. METHOD: We developed the SB-PACT web-based system based on stakeholder feedback, and conducted a pilot randomized trial with 100 children to establish its feasibility in facilitating preventive asthma care for high-risk children. The SB-PACT system represents a new model of care using web-based guides for asthma symptom screening, follow-up control assessments, and electronic communications with providers. RESULT: We enrolled and successfully screened all children using the web-based system. Most providers used the electronic communication system without difficulty, and the majority of children in the intervention group received preventive medications through school as planned and dose adjustments as needed. Several challenges to implementation also were encountered. CONCLUSIONS: This program is designed to promote sustainability of school-based asthma care, reduce program costs, and ultimately succeed in a real-world setting. With further refinements, it has the potential to be implemented nationally in schools.