Protocol for the development of a vaping cessation intervention for young adult veterans.

The use of e-cigarettes ("vaping") by young adults has increased substantially in the past decade. Although health risks of long-term e-cigarette use remain unknown, there is evidence of acute physiological harms. Most young adults who vape report intent to quit, but little is known about effective interventions. This protocol paper reports on the development and design of a pilot trial of a vaping intervention for young military Veterans. Young adult Veterans accessing VA healthcare (n = 20) who vape daily and have been referred for cessation services will be enrolled. To maximize accessibility the intervention will be delivered virtually; participants will be randomized to receive behavioral counseling by telephone or by video telehealth. The intervention was adapted from an existing program targeting young adult cigarette smokers and will include 6 individual counseling sessions delivered over 8 weeks. Assessment visits will occur at baseline, at end-of-treatment, and 4 weeks later. Analyses will evaluate feasibility and acceptability of the intervention overall, and will compare telephone and video telehealth modalities. Longitudinal regression will be used to evaluate changes in vaping behavior and in nicotine dependence over time. This study will provide assessment of a novel intervention adapted for Veterans who vape nicotine. The comparison of two modalities of virtual intervention delivery will increase knowledge and the potential to disseminate across VA and other healthcare systems. Findings from this pilot trial will inform the design of future, larger studies of vaping cessation interventions for younger Veterans.

Role of affective reactivity induced by cigarette packaging including graphic warning labels: the CASA Study.

OBJECTIVE: To identify whether three types of cigarette pack designs, including three versions of graphic warning label (GWL) plain packs, one GWL absent and branding absent pack (blank) and the smoker's own GWL absent and branding present pack (US), elicit different valence, type and levels of affect. DESIGN: US daily smokers (n=324) were asked to handle each of the five pack types and 'think aloud' their reactions. To avoid a muted familiarity response, exposure to their own US pack followed exposure to at least one GWL plain pack. Reactions were scored on a reactivity scale (-3 to +3) and the text was coded for speech polarity (-1 to +1) and emotive word frequency. RESULTS: Reactivity scores had excellent inter-rater reliability (agreement ≥86%; intraclass correlation coefficient ≥0.89) and were correlated with speech polarity (r=0.21-0.37, p<0.001). When considering their US pack, approximately two-thirds of smokers had a low (31.5%) to medium (34.6%) positive response (reactivity=1.29; polarity=0.14) with expressed feelings of joy and trust. Blank packaging prompted a largely (65.4%) neutral response (reactivity=0.03; polarity=0.00). The gangrenous foot GWL provoked mostly medium (46.9%) to high (48.1%) negative responses (reactivity=-2.44; polarity=-0.20), followed by neonatal baby (reactivity=-1.85; polarity=-0.10) and throat cancer (reactivity=-1.76; polarity=-0.08) warnings. GWLs varied in their elicitation of disgust, anger, fear and sadness. CONCLUSION: Initial reactions to GWL packs, a blank pack, and smokers' current US pack reflected negative, neutral, and positive affect, respectively. Different versions of the GWL pack elicited different levels and types of immediate negative affect.

A remotely delivered, peer-led intervention to improve physical activity and quality of life in younger breast cancer survivors.

Younger breast cancer survivors (YBCS) consistently report poorer quality of life (QOL) than older survivors. Increasing physical activity (PA) may improve QOL, but this has been understudied in YBCS. This single arm pilot study evaluated the feasibility and acceptability of a 3-month, peer-delivered, remote intervention to increase PA and improve QOL in YBCS. Data were collected from October 2019 - July 2020. Participants (n = 34, 43.1 ± 5.5 years old, 46 ± 34.4 months post-diagnosis, BMI = 30.2 ± 7.4 kg/m2) completed six video sessions with a trained peer mentor; self-monitored PA with a Fitbit activity tracker; and interacted with a private Fitbit Community for social support. At baseline, 3-and 6-months, participants completed QOL questionnaires and PA was measured through accelerometer (moderate-to-vigorous PA [MVPA]) and self-report (strength and flexibility). A parallel mixed-methods approach (qualitative interviews and quantitative satisfaction survey at 3-months) explored intervention feasibility and acceptability. One-way repeated-measures ANOVAs examined impacts on PA and QOL at 3-and 6-months. The intervention was feasible as evidenced by efficient recruitment, high retention, and adherence to intervention components. Remote delivery, working with a peer mentor, and using Fitbit tools were highly acceptable. From baseline to 3-months, participants increased time spent in objectively measured MVPA, strength, and flexibility exercises, and reported meaningful improvements to body image, fatigue, anxiety, and emotional support. A fully remote, peer-to-peer intervention is an acceptable and promising strategy to increase PA and improve QOL in YBCS. Refinements to the intervention and its delivery should be further assessed in future studies, toward the goal of disseminating an evidence-based, scalable intervention to the growing number of YBCS.Trial registration Prospectively registered as NCT04064892.

Effect of Graphic Warning Labels on Cigarette Packs on US Smokers' Cognitions and Smoking Behavior After 3 Months: A Randomized Clinical Trial.

Importance: The US Food and Drug Administration's implementation of graphic warning labels (GWLs) on cigarette packs is under challenge in US courts. Objective: To determine whether GWLs can affect US smokers' perceptions about their cigarettes or health consequences and changes in smoking behavior. Design, Setting, and Participants: This study was a randomized clinical trial of the effect of a 3-month, real-world experience of cigarettes with GWL packaging. Community recruitment was done from September 2016 through December 2019 of daily smokers from San Diego, California, aged 21 to 65 years, who were not ready to quit. Participants were randomized to purchase and receive cigarettes in 1 of 3 pack designs: GWL, blank, or standard US pack. Data analysis was performed from July 2020 to February 2021. Interventions: The study manufactured GWL cigarette packs (3 versions with Australian-licensed images) and packs devoid of marketing. For 3 months, participants purchased GWL, blank, or standard US pack cigarettes that were delivered to their home. Main Outcomes and Measures: Smoking-related cognitions and behavior were queried by daily and weekly interactive text messages. Smoking behavior was self-reported before and after the intervention by 96% of randomized participants and was biochemically validated on a subsample. Results: The study sample included 357 participants (195 women [54.6%]; mean [SD] age, 39.5 [11.9] years); 116 were randomized to the standard US pack group, 118 were randomized to the GWL pack group, and 125 were randomized to the blank pack group. Over the 3 months, participants who received the GWL packs had reduced positive perceptions of recent cigarettes smoked compared with participants who received the branded US pack (mean difference, -0.46 SD; 95% CI, -0.73 SD to -0.20 SD; P < .001). Health concerns increased in all groups, with a significant increase in the GWL group vs the US pack group (mean difference, 0.35 SD; 95% CI, 0.09 SD to 0.62 SD; P = .002). Quitting cognitions increased in all study groups, with a peak mean change of 0.60 SD for GWL participants vs 0.34 SD for US pack participants (mean difference, 0.55 SD; 95% CI, 0.28 SD to 0.81 SD; P < .001). GWL participants had slightly more cigarette abstinence periods per week than the US pack group, but the difference was not significant (adjusted odds ratio, 1.06; 95% CI, 0.99 to 1.13). At 3 months, there was no between-group difference in any smoking behavior. The blank pack group was similar to the US pack group on all measures. Conclusions and Relevance: These findings suggest that the introduction of GWL packs appears to decrease positive perceptions of cigarettes and increase quitting cognitions in the short term. However, additional complementary tobacco control strategies may be necessary for GWL packs to be associated with reduced smoking behavior. Trial Registration: ClinicalTrials.gov Identifier: NCT02676193.

Real-world exposure to graphic warning labels on cigarette packages in US smokers: The CASA randomized trial protocol.

BACKGROUND: The US lags behind >120 countries in implementing graphic warning labels (GWLs) on cigarette packs. US courts prevented implementation of FDA's 2012 rule requiring GWLs citing the need for more evidence on effectiveness. After more research, in 2020, the FDA proposed a revised rule mandating GWLs. This trial will test how the introduction of GWLs influence cognitions and behavior in US smokers. METHOD: To investigate the "real-world" impact of GWLs in US smokers, we are conducting a randomized trial involving a 3-month intervention and 8-month follow-up. The study recruited California smokers between September 2016 through December 2019 and randomly assigned them into 3 groups (1) Blank Pack devoid of any cigarette branding; (2) GWL Pack featuring 1 of 3 rotating images added to blank pack; or (3) their usual Standard US Pack. Throughout the 3-month intervention, participants purchased study-packaged cigarettes and reported daily cognitions and behavior through ecological momentary assessments. We will validate self-reported tobacco use with saliva cotinine concentrations following the 3-month intervention and 8-month follow-up. RESULTS: The trial enrolled 359 participants (average age 39 years; average cigarette consumption half a pack/day). The 3 study groups were balanced on age, gender, race-ethnicity, education and income (17% low income) as well as on smoking related variables. CONCLUSIONS: This 3-month real-world randomized trial will test the effect of repackaging cigarettes from standard US packs to GWL plain packs on smokers' perceptions of the risks of smoking, their perception of the appeal of their cigarettes, and on their smoking behavior.

A Remotely Delivered, Peer-Led Physical Activity Intervention for Younger Breast Cancer Survivors (Pink Body Spirit): Protocol for a Feasibility Study and Mixed Methods Process Evaluation.

BACKGROUND: Younger breast cancer survivors consistently report a greater impact of their cancer experience on quality of life compared with older survivors, including higher rates of body image disturbances, sexual dysfunction, and fatigue. One potential strategy to improve quality of life is through physical activity, but this has been understudied in younger breast cancer survivors, who often decrease their activity during and after cancer treatment. OBJECTIVE: The aim of this study is to explore the feasibility and acceptability of a technology-based, remotely delivered, peer-led physical activity intervention for younger breast cancer survivors. We will also assess the preliminary impact of the intervention on changes in physical activity and multiple aspects of quality of life. METHODS: This study is a community-academic partnership between University of California, San Diego and Haus of Volta, a nonprofit organization that promotes positive self-image in younger breast cancer survivors. This ongoing pilot study aims to recruit 30 younger breast cancer survivors across the United States (<55 years old, >6 months post primary cancer treatment, self-report <60 min of moderate-to-vigorous-intensity physical activity [MVPA]) into a 3-month peer-delivered, fully remote exercise program. Participants will complete 6 biweekly video chat sessions with a trained peer mentor, a fellow younger breast cancer survivor. Participants will receive a Fitbit Charge 3; weekly feedback on Fitbit data from their peer mentor; and access to a private, in-app Fitbit Community to provide and receive support from other participants and all peer mentors. At baseline, 3 months, and 6 months, participants will complete quality of life questionnaires, and MVPA will be measured using the ActiGraph accelerometer. Feasibility and acceptability will be explored through a mixed methods approach (ie, quantitative questionnaires and qualitative interviews). Intervention delivery and adaptations by peer mentors will be tracked through peer mentor self-evaluations and reflections, review of video-recorded mentoring sessions, and monthly templated reflections by the research team. RESULTS: Recruitment began in September 2019. As of February 2020, the physical activity intervention is ongoing. Final measures are expected to occur in summer 2020. CONCLUSIONS: This study explores the potential for physical activity to improve sexual function, body image, and fatigue, key quality of life issues in younger breast cancer survivors. Using peer mentors extends our reach into the young survivor community. The detailed process evaluation of intervention delivery and adaptations by mentors could inform a future hybrid-effectiveness implementation trial. Finally, remote delivery with commercially available technology could promote broader dissemination. TRIAL REGISTRATION: ClinicalTrials.gov NCT04064892; https://clinicaltrials.gov/ct2/show/NCT04064892. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18420.

Exploring Physician Attitudes Regarding Electronic Documentation of E-cigarette Use: A Qualitative Study.

BACKGROUND: In this article, we present qualitative work designed to explore physicians' attitudes toward and knowledge of electronic cigarettes (or Electronic Nicotine Delivery Systems-ENDS), particularly focusing on personal attitudes held by physicians regarding ENDS use, physician beliefs regarding the relative safety of ENDS, attitudes regarding the efficacy of ENDS as a smoking cessation tool, and how physicians' document ENDS use in the electronic health record (EHR). METHODS: We completed a total of 17 semistructured qualitative interviews with physicians in 4 different outpatient clinic locations. Clinics were selected with the goal of reaching patient panels across a diversity of socioeconomic and local geographic locations. RESULTS: The findings from our qualitative analysis suggest that physicians feel uninformed about the long-term health risks of ENDS and believe that they lack the critical medical knowledge required for discussing ENDS with their patients who smoke. Although physician responses did not endorse the view that ENDS use is a safer alternative to combustible tobacco use, approximately one-third of our physician sample did not hold strong objections to ENDS usage. Physicians placed varying degrees of importance on the issue of ENDS documentation practices. DISCUSSION: Three overarching themes were revealed from our analysis. These themes included (1) physicians' attitudes regarding the use of ENDS for smoking cessation, (2) physicians' guidance and advisement to patients in the use of ENDS for smoking cessation, and (3) current practices of clinical documentation of ENDS use in an EHR. Our qualitative results indicate that physicians in our study rarely screen patients for ENDS use, even for those patients who are both documented smokers and recipients of physician-led tobacco cessation counseling. However, most physicians agreed that the prospect of creating a structured data field specifically for the documentation of ENDS use within the EHR would result in the likelihood of increased screening and documentation of ENDS use patterns.

Participants' Perceptions on the Use of Wearable Devices to Reduce Sitting Time: Qualitative Analysis.

BACKGROUND: Recent epidemiological evidence indicates that, on average, people are sedentary for approximately 7.7 hours per day. There are deleterious effects of prolonged sedentary behavior that are separate from participation in physical activity and include increased risk of weight gain, cancer, metabolic syndrome, diabetes, and heart disease. Previous trials have used wearable devices to increase physical activity in studies; however, additional research is needed to fully understand how this technology can be used to reduce sitting time. OBJECTIVE: The purpose of this study was to explore the potential of wearable devices as an intervention tool in a larger sedentary behavior study through a general inductive and deductive analysis of focus group discussions. METHODS: We conducted four focus groups with 15 participants to discuss 7 different wearable devices with sedentary behavior capabilities. Participants recruited for the focus groups had previously participated in a pilot intervention targeting sedentary behavior over a 3-week period and were knowledgeable about the challenges of reducing sitting time. During the focus groups, participants commented on the wearability, functionality, and feedback mechanism of each device and then identified their two favorite and two least favorite devices. Finally, participants designed and described their ideal or dream wearable device. Two researchers, who have expertise analyzing qualitative data, coded and analyzed the data from the focus groups. A thematic analysis approach using Dedoose software (SocioCultural Research Consultants, LLC version 7.5.9) guided the organization of themes that reflected participants' perspectives. RESULTS: Analysis resulted in 14 codes that we grouped into themes. Three themes emerged from our data: (1) features of the device, (2) data the device collected, and (3) how data are displayed. CONCLUSIONS: Current wearable devices for increasing physical activity are insufficient to intervene on sitting time. This was especially evident when participants voted, as several participants reported using a "process of elimination" as opposed to choosing favorites because none of the devices were ideal for reducing sitting time. To overcome the limitations in current devices, future wearable devices designed to reduce sitting time should include the following features: waterproof, long battery life, accuracy in measuring sitting time, real time feedback on progress toward sitting reduction goals, and flexible options for prompts to take breaks from sitting.

Long-Term Acupuncture Therapy for Low-Income Older Adults with Multimorbidity: A Qualitative Study of Patient Perceptions.

OBJECTIVES: Multimorbidity is common, but often poorly managed, among the rapidly growing population of older adults. The existing guidelines followed by physicians frequently lead to polypharmacy and a complex treatment burden. The objective of this study was to explore what benefits are perceived by older adults with multimorbidity as a result of long-term, regular acupuncture treatment. DESIGN: A qualitative design with inductive thematic analysis of semistructured interviews. SETTINGS/LOCATION: Participants were recruited from a no-cost, college-affiliated acupuncture clinic for low-income older adults in an urban, racially/ethnically diverse neighborhood in southern California. PARTICIPANTS: Fifteen patients aged 60 years and older suffering from at least two chronic conditions. RESULTS: Five themes were identified: (1) mind-body effects, (2) the enhanced therapeutic alliance, (3) what they liked best, (4) the conventional healthcare system, and (5) importance of regular schedule. A notable mind-body effect, reported by a substantial number of participants, was medication reduction. Participants also cited changes in mood, energy, and well-being as important benefits. In addition, they voiced widespread dissatisfaction with conventional healthcare. Keeping up regular treatments as a way to deal with new complaints and encourage a healthier lifestyle was seen an important aspect of care at the clinic. CONCLUSIONS: This cohort of older adults with multimorbidity valued acupuncture as a way to reduce medication as well as a means to maintain physical and mental health. In addition, they developed a strong trust in the clinic's ability to support the totality of their health as individuals, which they contrasted to the specialized and impersonal approach of the conventional medical clinic.

A Qualitative Examination of Smoke-Free Policies and Electronic Cigarettes Among Sheltered Homeless Adults.

PURPOSE: To examine attitudes toward smoke-free policies and perceptions of e-cigarette use among homeless adults. APPROACH: A cross-sectional qualitative study was conducted. SETTING: Study setting comprised seven transitional homeless shelters with indoor smoke-free policies in San Diego County; facilities differed in outdoor restrictions on smoking. PARTICIPANTS: Sixty-six current or former smokers were the study participants. METHOD: Participants completed a questionnaire on smoking behaviors, perceived antitobacco norms, and attitudes toward smoke-free policies, and attended a focus group interview that explored these topics. We used a directed content analysis approach to analyze the focus group transcripts. RESULTS: Clients in facilities with outdoor restrictions on smoking had stronger perceived antitobacco norms than those in facilities without such restrictions. We identified the following major themes: attitudes toward smoke-free policies, the use of e-cigarettes, the addictive potential of cigarettes, vulnerability to tobacco industry marketing, and interest in smoking cessation. The consensus was that smoke-free policies were important because they limited secondhand smoke exposure to nonsmokers and children. All were curious about e-cigarettes, particularly if they could be smoked in areas where smoking was prohibited and/or used as a cessation aid. CONCLUSION: In this study of homeless adults, there was strong support for indoor and outdoor smoke-free policies. However, misperceptions that e-cigarettes could be used indoors could threaten antitobacco norms, highlighting opportunities to educate about the potential risks of e-cigarette use among homeless individuals.

Implementing Tobacco Control Programs in Homeless Shelters: A Mixed-Methods Study.

Background Tobacco-related chronic diseases contribute significantly to the increased morbidity and mortality observed in the homeless population. Few homeless service settings address tobacco use among their clients. Method Directors and staff from emergency and transitional shelters in San Diego County completed a questionnaire on no-smoking policies and smoking cessation services and participated in in-depth, semistructured interviews to examine the barriers to and facilitators of implementing smoke-free policies and cessation services in their facilities. Results Facilities differed in outdoor restrictions around smoking: 61.5% reported having an outdoor designated smoking zone, and 25% reported having a campus-wide ban on smoking. About one-third of the facilities offered on-site resources for smoking cessation. Although directors and staff supported smoke-free policies, they reported that the increased resources needed to "police" the policy created barriers to implementation. Almost all directors and staff expressed interest in developing an on-site tobacco control program, but they reported that lack of expertise among staff posed challenges to implementing such a program. Conclusion Our findings suggest that for a tobacco control program to be effective in homeless shelters, it should include training and incentives for staff to implement smoke-free policies and cessation services.

Modification of palm oil for anti-inflammatory nutraceutical properties.

Palm oil is one of the most important edible oils in the world. Its composition (rich in palmitate and oleate) make it suitable for general food uses but its utility could be increased if its fatty acid quality could be varied. In this study, we have modified a palm olein fraction by transesterification with the n-3 polyunsaturated fatty acids, alpha-linolenate or eicosapentaenoic acid (EPA). Evaluation of the potential nutritional efficacy of the oils was made using chondrocyte culture systems which can be used to mimic many of the degenerative and inflammatory pathways involved in arthritis. On stimulation of such cultures with interleukin-1alpha, they showed increased expression of cyclooxygenase-2, the inflammatory cytokines tumour necrosis factor-alpha (TNF-alpha), IL-1alpha and IL-1beta and the proteinase ADAMTS-4. This increased expression was not affected by challenge of the cultures with palm olein alone but showed concentration-dependent reduction by the modified oil in a manner similar to EPA. These results show clearly that it is possible to modify palm oil conveniently to produce a nutraceutical with effective anti-inflammatory properties.