Qualitative assessment of uptake retention and evaluation of prevention materials for skin cancer among Hispanics.

OBJECTIVE: Examine retention and evaluation of incorporating melanocortin-1 receptor genetic risk information materials in a skin cancer prevention intervention conducted in Hispanics living near Tampa, Florida and Ponce, Puerto Rico. METHODS: Two researchers applied thematic content analysis to identify major themes of open-ended responses (n = 1689) from 489 participants. RESULTS: Five major thematic categories emerged: 1) intervention comments; 2) tips and tricks; 3) cancer prevention; 4) general information; and 5) risk factors and genetics. Responses captured under intervention comments (e.g., information was clear, easy to understand) and tips and tricks for sun protection (e.g., using sunscreen, wearing protective clothing) were most frequent. Participants noted the importance of conducting skin exams professionally or at home. English-preferring Tampa residents stated their individual risk factors, especially race and/or ethnicity, more frequently than Ponce residents and Spanish-preferring Tampa residents. Ponce residents were more likely to comment on wanting to share intervention materials with family and friends. CONCLUSION: Findings suggest Hispanic participants implemented sun safety activities.

Assessment of skin cancer precision prevention materials among Hispanics in Florida and Puerto Rico.

OBJECTIVE: To assess Hispanic participants' ratings of intervention materials and examine differences by language preference. METHODS: Participants on a skin cancer prevention trial were randomized to receive generic (n = 457) or precision prevention materials conveying average (n = 195) or higher genetic risk (n = 268) based on MC1R genotype. Three months after receiving either English or Spanish language prevention materials, participants reported amount read, believability and clarity of materials, and intention to change preventive behavior. RESULTS: Participants reported high levels on all four outcomes, but the precision prevention groups noted lower clarity than the generic group (p = 3.2 ×10-6). Participants preferring Spanish provided consistently higher scores than those preferring English. Among English-preferring participants, those in the precision prevention groups scored lower on all measures than those in the generic group. CONCLUSIONS: Skin cancer prevention materials were well-received by Hispanic participants. Higher scores among participants preferring Spanish may indicate acquiescence bias, or that translated prevention materials met their linguistic needs. Participants in the precision prevention groups with English language preference may have challenges in the uptake of genetic risk results. PRACTICE IMPLICATIONS: Availability of Spanish materials may have facilitated higher scores. Additional strategies should be explored to optimize participants' believability and clarity of precision prevention materials.

Comparison of an automated smartphone-based smoking cessation intervention versus standard quitline-delivered treatment among underserved smokers: protocol for a randomized controlled trial.

BACKGROUND: Smoking is the leading cause of preventable morbidity and mortality in the United States. Individuals with low socioeconomic status have disproportionately high smoking rates and greater difficulty quitting smoking. Efficiently connecting underserved smokers to effective tobacco cessation programs is crucial for disease prevention and the elimination of health disparities. Smartphone-based interventions have the potential to enhance the reach and efficacy of smoking cessation treatments targeting underserved smokers, but there is little efficacy data for these interventions. In this study, we will partner with a large, local hunger-relief organization to evaluate the efficacy and economic impact of a theoretically-based, fully-automated, and interactive smartphone-based smoking cessation intervention. METHODS: This study will consist of a 2-group randomized controlled trial. Participants (N = 500) will be recruited from a network of food distribution centers in West Central Florida and randomized to receive either Standard Treatment (ST, n = 250) or Automated Treatment (AT, n = 250). ST participants will be connected to the Florida Quitline for telephone-based treatment and will receive a 10-week supply of nicotine replacement therapy (NRT; transdermal patches and lozenges). AT participants will receive 10 weeks of NRT and a fully-automated smartphone-based intervention consisting of interactive messaging, images, and audiovisual clips. The AT intervention period will span 26 weeks, with 12 weeks of proactive content and 26 weeks of on-demand access. ST and AT participants will complete weekly 4-item assessments for 26 weeks and 3-, 6-, and 12-month follow-up assessments. Our primary aim is to evaluate the efficacy of AT in facilitating smoking abstinence. As secondary aims, we will explore potential mediators and conduct economic evaluations to assess the cost and/or cost-effectiveness of ST vs. AT. DISCUSSION: The overall goal of this project is to determine if AT is better at facilitating long-term smoking abstinence than ST, the more resource-intensive approach. If efficacy is established, the AT approach will be relatively easy to disseminate and for community-based organizations to scale and implement, thus helping to reduce tobacco-related health disparities. TRIAL REGISTRATION: Clinical Trials Registry NCT05004662 . Registered August 13, 2021.

Self-help smoking cessation intervention for Spanish-speaking Hispanics/Latinxs in the United States: A randomized controlled trial.

BACKGROUND: Hispanic/Latinx smokers living in the United States face unique challenges in quitting smoking. This study evaluated the efficacy of a culturally relevant, Spanish-language, extended self-help smoking cessation intervention among Hispanic smokers. METHODS: A 2-arm parallel randomized controlled trial was conducted with Hispanic/Latinx smokers living in the United States who preferred health information in Spanish and smoked 5 or more cigarettes per week. Participants were randomly allocated to receive Libre del Cigarrillo (LDC), which consisted of 11 booklets and 9 pamphlets mailed monthly over 18 months, or the usual care (UC), which was a single Spanish-language self-help booklet from the National Cancer Institute. The primary outcome was self-reported 7-day point prevalence smoking abstinence assessed 6, 12, 18, and 24 months after the baseline. Eight prespecified moderators of the intervention were evaluated. Cost-effectiveness was also evaluated. All statistical tests were 2-sided. RESULTS: Data from all participants randomized to LDC (n = 714) or UC (n = 703) were used for analyses after multiple imputation to manage missing data. Generalized estimating equation analyses indicated that LDC abstinence rates were higher (P < .001) across all assessments. Logistic regression analyses revealed that at 24 months, the abstinence rate was greater for LDC (33.1%) than UC (24.3%; odds ratio, 1.54; 95% confidence interval, 1.18-2.02; P = .002). Men exhibited a strong intervention effect at all assessments (P values < .001), whereas the intervention effect for women was observed only at 6 and 12 months (P values < .018). In comparison with UC, the incremental cost per quitter in the LDC arm was $648.43 at 18 months and $683.93 at 24 months. CONCLUSIONS: A culturally relevant, Spanish-language intervention was efficacious and cost-effective for smoking cessation. LAY SUMMARY: Research is needed to develop interventions for ethnic minority smokers. The aim of the current study was to test a Spanish-language adaptation of a validated and easily implemented self-help smoking cessation intervention in a nationwide randomized controlled trial. The findings demonstrated that the intervention produced greater smoking abstinence in comparison with a standard self-help booklet. Participants also were more satisfied with the intervention, and it was cost-effective. Efforts aimed at promoting tobacco abstinence in this underserved population could have significant public health implications, including potential reductions in cancer health disparities associated with tobacco smoking.

Evaluating the Efficacy of Automated Smoking Treatment for People With HIV: Protocol for a Randomized Controlled Trial.

BACKGROUND: Smoking prevalence rates among people with HIV are nearly 3 times higher than those in the general population. Nevertheless, few smoking cessation trials targeting smokers with HIV have been reported in the literature. Efforts to develop and evaluate sustainable, low-cost, and evidence-based cessation interventions for people with HIV are needed. Given the widespread proliferation of mobile phones, the potential of using mobile health apps to improve the reach and efficacy of cessation interventions is promising, but evidence of efficacy is lacking, particularly among people with HIV. OBJECTIVE: This study will consist of a 2-group randomized controlled trial to evaluate a fully automated smartphone intervention for people with HIV seeking cessation treatment. METHODS: Participants (N=500) will be randomized to receive either standard treatment (ST; 250/500, 50%) or automated treatment (AT; 250/500, 50%). ST participants will be connected to the Florida Quitline and will receive nicotine replacement therapy in the form of transdermal patches and lozenges. This approach, referred to as Ask Advise Connect, was developed by our team and has been implemented in numerous health systems. ST will be compared with AT, a fully automated behavioral treatment approach. AT participants will receive nicotine replacement therapy and an interactive smartphone-based intervention that comprises individually tailored audiovisual and text content. The major goal is to determine whether AT performs better in terms of facilitating long-term smoking abstinence than the more resource-intensive ST approach. Our primary aim is to evaluate the efficacy of AT in facilitating smoking cessation among people with HIV. As a secondary aim, we will explore potential mediators and moderators and conduct economic evaluations to assess the cost and cost-effectiveness of AT compared with ST. RESULTS: The intervention content has been developed and finalized. Recruitment and enrollment will begin in the fall of 2021. CONCLUSIONS: There is a critical need for efficacious, cost-effective, and sustainable cessation treatments for people with HIV who smoke. The AT intervention was designed to help fill this need. If efficacy is established, the AT approach will be readily adoptable by HIV clinics and community-based organizations, and it will offer an efficient way to allocate limited public health resources to tobacco control interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT05014282; https://clinicaltrials.gov/ct2/show/NCT05014282. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/33183.

Targeted smoking cessation for dual users of combustible and electronic cigarettes: a randomised controlled trial.

BACKGROUND: Although many smokers use electronic cigarettes (e-cigarettes) to quit smoking, most continue to smoke while vaping. This dual use might delay cessation and increase toxicant exposure. We aimed to test the efficacy of a self-help intervention designed to help dual users to quit smoking. METHODS: In this three-arm randomised controlled trial we recruited individuals in the USA using Facebook and multimedia advertisements. Included participants were 18 years or older, smoked at least weekly in the preceding year, and vaped at least weekly in the preceding month. We used computer generated randomisation with balanced-permuted blocks (block size 10, with 2-4-4 ratio) to allocate participants to assessment only (ASSESS group), generic smoking cessation self-help booklets (GENERIC group), or booklets targeting dual users (eTARGET group). Individuals in the generic or targeted intervention groups received monthly cessation materials for 18 months, with assessments every 3 months for 24 months. The main outcome was self-reported 7-day point-prevalence smoking abstinence at each assessment point. All randomly allocated participants were included in primary analyses using generalised estimating equations for each of 20 datasets created by multiple imputation. Analysis of the χ2s produced an F test. The trial is registered with ClinicalTrials.gov, NCT02416011, and is now closed. FINDINGS: Between July 12, 2016, and June 30, 2017, we randomly assigned 2896 dual users (575 to assessment, 1154 to generic intervention, and 1167 to targeted self-help). 7-day point-prevalence smoking abstinence increased from 14% at 3 months to 42% at 24 months (F7,541·7=67·1, p<0·0001) in the overall sample. Targeted self-help resulted in higher smoking abstinence than did assessment alone throughout the treatment period (F1,973·8=10·20, p=0·0014 [α=0·017]). The generic intervention group had abstinence rates between those of the assessment and targeted groups, but did not significantly differ from either when adjusted for multiple comparisons (GENERIC vs eTARGET F1,1102·5=1·79, p=0·18 [α=0·05]; GENERIC vs ASSESS F1,676·7=4·29, p=0·039 [α=0·025]). Differences between study groups attenuated after the interventions ended. INTERPRETATION: A targeted self-help intervention with high potential for dissemination could be efficacious in promoting smoking cessation among dual users of combustible cigarettes and e-cigarettes. FUNDING: National Institute on Drug Abuse, National Cancer Institute.

Demographic and psychosocial factors associated with limited health literacy in a community-based sample of older Black Americans.

OBJECTIVES: Individuals with limited health literacy often experience suboptimal health outcomes. This study examined the frequency of limited health literacy and demographic and psychosocial factors associated with limited health literacy in a sample of older Black Americans. METHODS: Participants (n = 330) enrolled in a community-based intervention to promote colorectal cancer (CRC) screening completed baseline surveys assessing health literacy with the Rapid Estimate of Adult Literacy in Medicine, Revised (REALM-R) test, CRC awareness, cancer fatalism, Preventive Health Model (PHM) constructs, and demographics. RESULTS: Approximately 52% of participants had limited health literacy, the REALM-R score was 5.4 (SD = 2.7). Univariable correlates of limited health literacy were gender, employment, income, prior screening, cancer fatalism, CRC awareness, and PHM constructs (religious beliefs, salience/coherence, perceived susceptibility). Multivariable correlates of limited health literacy were male gender (OR = 2.3, CI = 1.4-3.8), unable to work (OR = 2.8, CI = 1.3-6.1), lower household income (OR = 3.0, CI = 1.6, 5.5), and higher PHM religious beliefs (OR = 1.1, CI = 1.0-1.2). CONCLUSION: Limited health literacy was associated with multiple complex factors. Interventions should incorporate patient health literacy and low-literacy materials that can be delivered through multiple channels. PRACTICE IMPLICATIONS: Future studies are needed to understand the role of health literacy in an individual's health behavior and the provision of effective healthcare.

Health Literacy among Medically Underserved: The Role of Demographic Factors, Social Influence, and Religious Beliefs.

The current study examined the sociodemographic and psychosocial variables that predicted being at risk for low health literacy among a population of racially and ethnically diverse patients accessing primary care services at community-based clinics. Participants (N = 416) were aged 50-75 years, currently not up-to-date with colorectal cancer (CRC) screening, at average CRC risk, and enrolled in a randomized controlled trial (RCT) aimed at promoting CRC screening. Participants completed a baseline interview that assessed health literacy as measured by Rapid Estimate of Adult Literacy in Medicine-Revised, sociodemographic factors, and psychosocial variables (e.g., health beliefs) prior to randomization and receipt of an intervention. Thirty-six percent of the participants were found to be at risk for low health literacy. Sociodemographic and psychosocial variables were assessed as predictors of being at risk for low health literacy using logistic regression. In the final model, predictors were male gender, being from a racial/ethnic minority group, being unable to work, having higher social influence scores, and having higher religious belief scores. These findings suggest several patient characteristics that may be associated with low health literacy, and highlight the importance of supporting all patients through simplified and clear communications and information to improve understanding of CRC screening information.

Sexual and Gender Minority Issues Across NCCN Guidelines: Results From a National Survey.

Background: The lesbian, gay, bisexual, transgender, queer/questioning (LGBTQ) population is at higher risk for multiple types of cancers compared with the heterosexual population. Expert NCCN panels lead the nation in establishing clinical practice guidelines addressing cancer prevention, early detection, and treatment of cancer sites and populations. Given the emergence of new data identifying cancer disparities in the LGBTQ population, this study examined the inclusion of medical and/or psychosocial criteria unique to LGBTQ within NCCN Guidelines. Methods: Data were collected for 32 of the 50 NCCN Guidelines. Results: NCCN panel members reported that neither sexual orientation (84%) nor gender identity (94%) were relevant to the focus of their guidelines; 77% responded that their panels currently do not address LGBTQ issues, with no plans to address them in the future. Conclusions: Greater consideration should be given to the needs of LGBTQ patients across the cancer care continuum. Given that research concerning LGBTQ and cancer is in its infancy, additional empirical and evidence-based data are needed to bolster further integration of LGBTQ-specific criteria into clinical care guidelines.

A randomized controlled trial of a smoking cessation self-help intervention for dual users of tobacco cigarettes and E-cigarettes: Intervention development and research design.

Electronic Nicotine Delivery Systems, also called electronic cigarettes or e-cigarettes, have been available for over a decade and use has been increasing dramatically. The primary reported reasons for use are to aid smoking cessation or reduction, yet a significant proportion appear to be long-term users of both products ("dual users"). Dual users may be motivated to quit smoking and might benefit from a behavioral intervention for smoking cessation. This paper describes the intervention development, as well as the design, methods, and data analysis plans for an ongoing randomized controlled trial (RCT). Formative research and learner verification were conducted to create a usable, understandable, and acceptable self-help intervention targeting dual users. The efficacy is being tested in an RCT with current dual users (N=2900) recruited nationally and randomized to one of three conditions. The Assessment Only (ASSESS) group only completes assessments. The Generic Self-Help (GENERIC) group receives non-targeted smoking cessation booklets and supplemental materials sent monthly over 18months. The e-cigarette Targeted Self-Help (eTARGET) group receives the newly developed intervention (targeted booklets and supplemental materials) sent over the same period. All participants complete self-report surveys every 3months over 2years. The primary study outcome is self-reported 7-day point prevalence abstinence. Cost-effectiveness metrics for the GENERIC and eTARGET interventions will also be calculated.

A randomized clinical trial of self-help intervention for smoking cessation: research design, interventions, and baseline data.

Tobacco smoking is the leading preventable cause of mortality and morbidity. Although behavioral counseling combined with pharmacotherapy is the most effective approach to aiding smoking cessation, intensive treatments are rarely chosen by smokers, citing inconvenience. In contrast, minimal self-help interventions have the potential for greater reach, with demonstrated efficacy for relapse prevention, but not for smoking cessation. This paper summarizes the design and methods used for a randomized controlled trial to assess the efficacy of a minimal self-help smoking cessation intervention that consists of a set of booklets delivered across time. Baseline participant recruitment data are also presented. Daily smokers were recruited nationally via multimedia advertisements and randomized to one of three conditions. The Usual Care (UC) group received a standard smoking-cessation booklet. The Standard Repeated Mailings (SRM) group received 8 booklets mailed over a 12-month period. The Intensive Repeated Mailings (IRM) group received 10 booklets and additional supplemental materials mailed monthly over 18months. A total of 2641 smokers were screened, 2349 were randomized, and 1874 provided data for analyses. Primary outcomes will be self-reported abstinence at 6-month intervals up to 30months. If the self-help booklets are efficacious, this minimal, low cost intervention can be widely disseminated and, hence, has the potential for significant public health impact with respect to reduction in smoking-related illness and mortality.

An automated process for building reliable and optimal in vitro/in vivo correlation models based on Monte Carlo simulations.

Many mathematical models have been proposed for establishing an in vitro/in vivo correlation (IVIVC). The traditional IVIVC model building process consists of 5 steps: deconvolution, model fitting, convolution, prediction error evaluation, and cross-validation. This is a time-consuming process and typically a few models at most are tested for any given data set. The objectives of this work were to (1) propose a statistical tool to screen models for further development of an IVIVC, (2) evaluate the performance of each model under different circumstances, and (3) investigate the effectiveness of common statistical model selection criteria for choosing IVIVC models. A computer program was developed to explore which model(s) would be most likely to work well with a random variation from the original formulation. The process used Monte Carlo simulation techniques to build IVIVC models. Data-based model selection criteria (Akaike Information Criteria [AIC], R2) and the probability of passing the Food and Drug Administration "prediction error" requirement was calculated. To illustrate this approach, several real data sets representing a broad range of release profiles are used to illustrate the process and to demonstrate the advantages of this automated process over the traditional approach. The Hixson-Crowell and Weibull models were often preferred over the linear. When evaluating whether a Level A IVIVC model was possible, the model selection criteria AIC generally selected the best model. We believe that the approach we proposed may be a rapid tool to determine which IVIVC model (if any) is the most applicable.