A Qualitative Study of Quality of Life Concerns following a Melanoma Diagnosis

The goal of this study was to identify a relevant and inclusive list of quality of life issues among long-term survivors of melanoma. Individuals diagnosed with stage I-III cutaneous melanoma and had survived 1-5 years, ages 18-65 years at diagnosis, were recruited. Five focus groups were conducted with 33 participants in total. Discussions centered on participants' experiences at diagnosis, as well as ongoing physical, emotional, and social concerns, and behavioral changes since diagnosis. The majority of participants reported shock, fear, and feeling overwhelmed at the time of diagnosis. Some reported lingering physical concerns, including pain, numbness, and lymphedema, while a few reported no lasting issues. Emotional concerns were common, with most reporting anxiety. Several also noted feeling lonely and isolated. Social concerns included alteration of activities to avoid sun exposure, issues with family communication, and frustration with the lack of appreciation of the seriousness of melanoma by others. Finally, while many participants reported changes to their sun exposure and UV-protection behaviors, some reported little to no change. The shared experiences among participants in this study confirm the unique nature of melanoma and the need for interventions designed to improve the health and quality of life of melanoma survivors. Background Melanoma, one of the most serious types of skin cancer, is unlike most common cancer types in that the incidence has been increasing over the past 30 years QOL is a multidimensional concept that incorporates physical, psychological, and social functioning; an individuals' overall life satisfaction, perceptions of their health status, and ability to take part in valued activities are important components. To date, a limited number of studies examining QOL issues have been carried out in long-term melanoma survivors. The majority of these studies relied on currently available generic and cancer-specific instruments to assess a narrow range of issues, primarily related to emotional distress, anxiety, depression and psychosocial adjustment, or overall QOL The objective of the research reported here was to conduct focus groups to identify a relevant and inclusive list of QO

Development and Piloting Testing of an Experimental Tobacco and Nicotine Product Marketplace.

IntroductionWe describe the development and pilot testing of the experimental tobacco and nicotine product marketplace (ETM)-a method for studying tobacco and nicotine product (TNP) choices and use behavior in a standardized way.Aims and methodsThe ETM resembles an online store populated with TNPs. Surveillance activities and data from a US representative survey and consumer reports were used to determine the most popular TNPs for inclusion in the ETM. Standardized information and videos demonstrating how to use the TNPs were provided. To test the feasibility of using the ETM, smokers (n = 119) underwent monitoring of usual brand cigarette smoking and other TNP use (Baseline Phase) followed by access to the ETM (ETM Phase) that included their usual brand cigarettes, e-cigarettes, moist snuff, snus, and nicotine replacement therapy. During the ETM Phase, participants were provided points based on their baseline TNP consumption to exchange for TNPs in the ETM. Participants were advised to exchange points for enough TNPs to last until their next visit and to refrain from using TNPs not obtained in the ETM. A subset of the participants (n = 62) completed a survey on their experience with the ETM.ResultsThe majority of the participants stated they were comfortable with navigating the ETM (97%), it was easy to determine product characteristics (89%), and they were satisfied with the products included in the marketplace (85%).ConclusionsThe ETM was well received by the vast majority of the participants and can be utilized by researchers to investigate a variety of TNP policy and regulatory science research questions.ImplicationsPatterns of TNP use are complex due to greater availability, marketing, and promotion of a diverse array of TNPs. Innovative methods are needed to experimentally study TNP choices and patterns. Through describing the development of the ETM, we provide researchers with a tool that can be readily adapted to studying a variety of phenomena challenging public health

Smoking abstinence and cessation-related outcomes one month after an immediate versus gradual reduction in nicotine content of cigarettes.

The United States Food and Drug Administration has the authority to reduce the nicotine content in cigarettes to minimal or non-addictive levels and could do so immediately or gradually over time. A large clinical trial compared the two approaches. This secondary analysis assesses abstinence and cessation-related outcomes one month after the trial concluded, when participants no longer had access to very low nicotine content (VLNC) research cigarettes. Smokers not interested in quitting (N = 1250) were recruited for the parent trial from 2014 to 2016 across 10 sites throughout the US and randomized to a 20-week study period during which they immediately switched to VLNC cigarettes, gradually transitioned to VLNC cigarettes with five monthly dose reductions, or smoked normal nicotine research cigarettes (control). At the one-month follow-up, both immediate and gradual reduction resulted in greater mean cigarette-free days (4.7 and 4.6 respectively) than the control group (3.2, both p < .05). Immediate reduction resulted in fewer mean cigarettes per day (CPD = 10.3) and lower Fagerström Test for Cigarette Dependence (FTCD = 3.7) than the gradual (CPD = 11.7, p = .001; FTCD = 3.8, p = .039) and control (CPD = 13.5, p < .001; FTCD = 4.0, p < .001) groups. Compared to controls, gradual reduction resulted in reduced CPD (p = .012) but not FTCD (p = .13). Differences in CO-verified 7-day point-prevalence abstinence were not significant. Findings demonstrate that switching to VLNC cigarettes resulted in reduced smoking and nicotine dependence severity that was sustained for at least a month after the VLNC trial period in smokers who were not interested in cessation. The greatest harm reduction endpoints were observed in those who immediately transitioned to VLNC cigarettes

Reduced nicotine in cigarettes in a marketplace with alternative nicotine systems: randomized clinical trial.

BACKGROUND: Reducing cigarette addictiveness has the potential to avert millions of yearly tobacco-related deaths worldwide. Substantially reducing nicotine in cigarettes decreases cigarette consumption, but no large clinical trial has determined the effects of reduced-nicotine cigarettes when other nicotine-containing products are available. The aim of this study was to examine the effects of reduced-nicotine cigarettes in the context of the availability of alternative nicotine delivery systems. METHODS: In a U.S. six-site, open-label, parallel-arm study, smokers were randomized for twelve weeks to an experimental marketplace containing cigarettes with either 0.4 mg or 15.8 mg nicotine per gram of tobacco; all had access to non-combusted alternative nicotine delivery systems (e.g., e-cigarettes; medicinal nicotine). Group differences in the primary outcomes (cigarettes per day, number of smoke-free days) were examined using linear and negative binomial regression, respectively (Trial Registration: NCT03272685). FINDINGS: Among 438 randomized participants (mean [standard deviation (SD), range] age, 44.5 [11.9, 20-73] years, 225 [51.4%] women, 282 [64.4%] White and 339 [77.4%] trial completers), those in the 0.4 mg vs. 15.8 mg nicotine cigarette condition experienced significantly lower cigarettes per day at the end of intervention (mean [SD], 7.05 [7.88] vs. 12.95 [9.07], adjusted mean difference, -6.21 [95% CI, -7.66 to -4.75], P < 0.0001) and greater smoke-free days during intervention (mean [SD], 18.59 [27.97] vs. 5.06 [13.77], adjusted rate ratio, 4.25 [95% CI, 2.58-6.98], P < 0.0001). INTERPRETATION: A reduced-nicotine cigarette standard in the context of access to other non-combusted nicotine products has the potential to benefit public health. FUNDING: U.S. NIH/FDA U54DA03165

When will the zebra mussel reach Florence? A model for the spread of Dreissena polymorpha in the Arno water system (Italy)

The zebra mussel (Dreissena polymorpha) is a freshwater bivalve that has caused dramatic ecological and economic impacts worldwide in the last decades. Its success as ecosystem invader is mainly due to the species ability of spreading along rivers, together with the extremely high population densities that can be reached by local populations. Here we propose a spatially explicit model aimed at describing the population dynamics of mussel colonies in rivers represented as oriented graphs. We specifically apply the model to the Bilancino-Sieve-Arno water system (Tuscany, Italy), where D. polymorpha has been recently sighted. The model accounts for local scale demographic processes and along-stream transport mechanisms. Because of the different temporal scales involved, we couple continuous- and discrete-time dynamics. Our model produces spatiotemporal scenarios of invasion that present several distinctive features of the zebra mussel invasion patterns observed in nature, including the spatial patchiness and the temporal irregularity of local populations, and the so-called domino effect. The application of our model to the Arno case study shows that D. polymorpha could severely threaten the city of Florence within a few years. Control measures aimed at limiting the impact of the species can significantly alter the ecological and environmental parameters. We find that such variations may profoundly impact spatiotemporal invasion patterns, possibly with counter-intuitive effects. For instance, reduced larval input from Lake Bilancino can in some cases produce higher mussel densities in downstream colonies. Therefore, the control of D. polymorpha must be planned with care in order to prevent unwelcome outcomes

Effect of Immediate vs Gradual Reduction in Nicotine Content of Cigarettes on Biomarkers of Smoke Exposure: A Randomized Clinical Trial.

ImportanceThe optimal temporal approach for reducing nicotine to minimally or nonaddictive levels in all cigarettes sold in the United States has not been determined.ObjectivesTo determine the effects of immediate vs gradual reduction in nicotine content to very low levels and as compared with usual nicotine level cigarettes on biomarkers of toxicant exposure.Design, setting, and participantsA double-blind, randomized, parallel-design study with 2 weeks of baseline smoking and 20 weeks of intervention was conducted at 10 US sites. A volunteer sample of daily smokers with no intention to quit within 30 days was recruited between July 2014 and September 2016, with the last follow-up completed in March 2017.Interventions(1) Immediate reduction to 0.4 mg of nicotine per gram of tobacco cigarettes; (2) gradual reduction from 15.5 mg to 0.4 mg of nicotine per gram of tobacco cigarettes with 5 monthly dose changes; or (3) maintenance on 15.5 mg of nicotine per gram of tobacco cigarettes.Main outcomes and measuresBetween-group differences in 3 co-primary biomarkers of smoke toxicant exposure: breath carbon monoxide (CO), urine 3-hydroxypropylmercapturic acid (3-HPMA, metabolite of acrolein), and urine phenanthrene tetraol (PheT, indicator of polycyclic aromatic hydrocarbons) calculated as area under the concentration-time curve over the 20 weeks of intervention.ResultsAmong 1250 randomized participants (mean age, 45 years; 549 women [44%]; 958 [77%] completed the trial), significantly lower levels of exposure were observed in the immediate vs gradual reduction group for CO (mean difference, -4.06 parts per million [ppm] [95% CI, -4.89 to -3.23]; P < .0055), 3-HPMA (ratio of geometric means, 0.83 [95% CI, 0.77 to 0.88]; P < .0055), and PheT (ratio of geometric means, 0.88 [95% CI, 0.83 to 0.93]; P < .0055). Significantly lower levels of exposure were observed in the immediate reduction vs control group for CO (mean difference, -3.38 [95% CI, -4.40 to -2.36]; P < .0055), 3-HPMA (ratio of geometric means, 0.81 [95% CI, 0.75 to 0.88]; P < .0055), and PheT (ratio of geometric means, 0.86 [95% CI, 0.81 to 0.92]; P < .0055). No significant differences were observed between the gradual reduction vs control groups for CO (mean difference, 0.68 [95% CI, -0.31 to 1.67]; P = .18), 3-HPMA (ratio of geometric means, 0.98 [95% CI, 0.91 to 1.06]; P = .64), and PheT (ratio of geometric means, 0.98 [95% CI, 0.92 to 1.04]; P = .52).Conclusions and relevanceAmong smokers, immediate reduction of nicotine in cigarettes led to significantly greater decreases in biomarkers of smoke exposure across time compared with gradual reduction or a control group, with no significant differences between gradual reduction and control.Trial registrationclinicaltrials.gov Identifier: NCT02139930