Lessons Learned From the Creating Active Communities and Healthy Environments Toolkit Pilot: A Qualitative Study.
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ABSTRACT:
SUBMITTER: Shams-White MM
PROVIDER: S-EPMC6628517 | biostudies-literature | 2019
REPOSITORIES: biostudies-literature
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Lessons Learned From the Creating Active Communities and Healthy Environments Toolkit Pilot: A Qualitative Study.
Shams-White Marissa M MM Cuccia Alison A Ona Fernando F Bullock Steven S Chui Kenneth K McKeown Nicola N Must Aviva A
Environmental health insights 20190712
The US Army Public Health Center developed the Creating Active Communities and Healthy Environments (CACHE) Toolkit to help military installations evaluate the quality of their built environments relative to healthy eating, physical activity, and tobacco-free living. This study sought to improve its implementation process and assess subsequent Action Plan Guides' utility at 5 military installations. Baseline data included a knowledge, attitudes, and beliefs survey (N = 34); post-Toolkit implemen ...[more]
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Project description:Introduction: Peri-operative window trials, using molecular biomarkers as surrogate endpoints for treatment response, offer investigators a uniqueopportunity to obtain intact tumor samples at 2 different time-points and thus evaluate potential biomarkers over a short period of time. Here we report results of a pilot trial designed to determine if treatment-mediated changes in gene expression can be detected after a 10-day exposure to anastrozole in estrogen receptor (ER)-positive breast cancer compared to untreated controls. Methods: Paired tumor samples (biopsy and surgical) were obtained from 26 postmenopausal women with ER-positive breast cancer. Patients were assigned anastrozole (1mg/dy) for 10 days immediately prior to surgery (13 cases) or no treatment (13 controls). 502 cancer-related genes were examined by the DASL FFPE-based cDNA array (moderated t-test, p ≤ .005). Surrogate biomarkers reflecting changes in gene expression were examined by immunohistochemistry (IHC) (Wilcoxon rank-based test, p < .05). Results: Sufficient RNA was available from 19 paired samples (8 controls, 11 cases). There was no difference in age, tumor size, grade, or baseline biomarker expression between groups. Within each group, 18 genes, reflecting roles in proliferation, angiogenesis, and apoptosis showed differential expression over time from biopsy to surgery (p < 0.005). Dysregulation of estrogen-related genes was present only in the treated group. Comparison between groups identified 5 genes that were significantly dysregulated between controls and treated cases (BAG1/ING1/ERBB4/IFNGR1/TFDP1). Reduction in Ki-67 index was observed in 7 (54%) treated cases in 1 (7.7%) control patient. Conclusions: Short-term (10-day) exposure to anastrozole resulted in significant dysregulation of 18 out of 502 cancer-related genes, and Ki-67 was reduced in 54% of cases. However, the local effects of wound healing may represent a confounding factor in the interpretation of peri-operative window trials as exposed by the changes in gene expression and the increased Ki-67 index in the control group. Prospective, paired tumor samples (biopsy and surgical) were obtained from 26 postmenopausal women with ER-positive breast cancer. Patients were assigned anastrozole (1mg/dy) for 10 days immediately prior to surgery (13 cases) or no treatment (13 controls). 502 cancer-related genes were examined by the DASL FFPE-based cDNA array. Sufficient RNA for gene expression analysis was obtained from 19/26 (73%) FFPE paired (biopsy and surgery) samples (8 controls, 11 anastrozole-treated patients
2011-07-01 | E-GEOD-26544 | biostudies-arrayexpress
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Project description:Background and purposePediatric populations represent a vulnerable research group. Careful thought must be given to many factors when designing and implementing pediatric intervention research studies. This article discusses methodological and implementation lessons learned from two pediatric intervention pilot studies and highlights facilitators and barriers encountered.Type of methodBoth studies used a pre/post with 6-week follow-up method and were adapted versions of an evidence-based program, Creating Opportunities for Personal Empowerment (COPE).Essential featuresCOPE is a 7-session, cognitive behavioral skills building intervention. COPE for Asthma was implemented in schools with small groups for elementary-aged children with asthma and symptoms of anxiety. Mindstrong to Combat Bullying was implemented individually in the outpatient mental health setting for adolescents who had experienced bullying with concurrent symptoms of depression/anxiety.Methodological applicationBoth intervention studies were successful in achieving their research aims, but more importantly the authors learned important lessons in how to successfully work with pediatric populations in research studies. Legal considerations, such as mandated reporting, suicide risk assessment and the inclusion of parents are reviewed. Other components, such as working with children vs. adolescents, integrating research into school-based settings vs. clinic-based settings, and completing intervention research in a group setting vs. individual setting are discussed.ConclusionsThe two pilot studies highlight important factors to consider when designing and implementing pediatric intervention studies. While challenges arise in working with this vulnerable population, research is ultimately needed to provide the best evidence-based care for our future generations.Clinical trial registrationThe COPE for Asthma study is registered at www.ClinicaltrialsgovNCT03481673.
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