The prevalence of smoking among cervical cancer survivors is high and evidence-based smoking cessation interventions are critically needed. This paper describes the study design, methods, and data ...analysis plans for a randomized clinical trial (RCT) designed to evaluate the efficacy of a novel, personally tailored SMS-delivered text-based digital treatment adjuvant designed to enhance the long-term efficacy of a "Motivation And Problem-Solving" (MAPS) approach for smoking cessation among individuals with a history of cervical intraepithelial neoplasia (CIN) or cervical cancer. MAPS is a phone counseling approach designed to facilitate long-term abstinence that comprises 6 counseling calls over 12 months. The current trial is evaluating the efficacy of MAPS+, which comprises all MAPS components plus a 24-month digital treatment adjuvant. This trial represents a logical extension of our previous RCT, which compared the efficacy of MAPS to a quitline control condition and found that MAPS resulted in greater than a 2-fold increase in smoking abstinence at 12 months (i.e., 26.4% vs. 11.9%). This treatment effect was no longer significant at 18 months, suggesting that efficacy dissipated as time from the end of treatment increased. The primary aim of the current trial is to compare the efficacy of MAPS + and ST in facilitating long-term abstinence.
Individuals who smoke and have a history of cervical cancer or CIN (N = 340) are recruited throughout Florida and randomly assigned to Standard Treatment ST or MAPS+. ST participants are electronically connected with the Florida Quitline. MAPS + consists of 6 proactive MAPS-based counseling calls over 12 months plus the novel, personally tailored, text message-based treatment adjuvant delivered over 24 months. All participants receive 12 weeks of combination nicotine replacement therapy (patch and lozenge) and are followed for 24 months. Participant recruitment commenced in December 2022 and is ongoing.
This study builds on promising results from our recent trial which found that MAPS was associated with substantially higher abstinence from smoking at the end of the 12-month treatment period. Finding that this low-burden, personally tailored digital treatment adjuvant improves the long-term efficacy of MAPS would have important clinical and public health implications.
Clinical Trials Registry NCT05645146; https://clinicaltrials.gov/ct2/show/NCT05645146 ; Registered on December 9, 2022.
To identify potential gaps in attitudes, knowledge, and institutional practices toward lesbian, gay, bisexual, transgender, and queer/questioning (LGBTQ) patients, a national survey of oncologists at ...National Cancer Institute-Designated Comprehensive Cancer Centers was conducted to measure these attributes related to LGBTQ patients and desire for future training and education.
A random sample of 450 oncologists from 45 cancer centers was selected from the American Medical Association's Physician Masterfile to complete a survey measuring attitudes and knowledge about LGBTQ health and institutional practices. Results were quantified using descriptive and stratified analyses and by a novel attitude summary measure.
Of the 149 respondents, there was high agreement (65.8%) regarding the importance of knowing the gender identity of patients, which was contrasted by low agreement (39.6%) regarding the importance of knowing sexual orientation. There was high interest in receiving education regarding the unique health needs of LGBTQ patients (70.4%), and knowledge questions yielded high percentages of "neutral" and "do not know or prefer not to answer" responses. After completing the survey, there was a significant decrease ( P < .001) in confidence in knowledge of health needs for LGB (53.1% agreed they were confident during survey assessment v 38.9% postsurvey) and transgender patients (36.9% v 19.5% postsurvey). Stratified analyses revealed some but limited influence on attitudes and knowledge by having LGBTQ friends and/or family members, political affiliation, oncology specialty, years since graduation, and respondents' region of the country.
This was the first nationwide study, to our knowledge, of oncologists assessing attitudes, knowledge, and institutional practices of LGBTQ patients with cancer. Overall, there was limited knowledge about LGBTQ health and cancer needs but a high interest in receiving education regarding this community.
The Abstinence-Related Motivational Engagement (ARME) scale was developed to assess motivation to remain abstinent after a smoking cessation attempt. The ARME demonstrated reliability and validity ...among a small sample of ex-smokers. This study expands the psychometric evaluation of the ARME and tests the ARME as a predictor of smoking status among a sample of participants quitting smoking. The parent trial tested the efficacy of a self-help smoking cessation intervention (N = 1874), with assessments every 6 months. Internal consistency and factor structure of the ARME was evaluated at each assessment to confirm use of the measure as designed. Discriminant validity was assessed by comparing the ARME to the Situation-specific Abstinence Self-Efficacy (SSE) scale via inter-correlations and prediction of future smoking status. Finally, the trajectories of both the ARME and SSE were compared among continuous abstainers and continuous smokers. A single-factor structure was observed at each assessment. Cronbach's alphas ranged from 0.88-0.91 for the total sample. Correlations between the ARME and the SSE ranged from 0.38-0.47 (ps <0.001) among smokers; and from 0.09-0.15 (most ps > 0.05) among abstainers. Among current smokers, the ARME and SSE were independent positive predictors of subsequent abstinence (AORs 1.28-2.29, ps <0.001). For those currently abstinent, only the SSE predicted subsequent abstinence (AORs 1.69-2.60, ps <0.05). GEE analyses showed different trajectories for the two measures, as well as between abstainers and smokers. In conclusion, the ARME is a reliable, valid measure with unique predictive utility for current smokers and a distinct trajectory among those who have successfully quit.
Men receiving androgen-deprivation therapy (ADT) for prostate cancer may be at risk for cognitive impairment; however, evidence is mixed in the existing literature. Our study examined the impact of ...ADT on impaired cognitive performance and explored potential demographic and genetic predictors of impaired performance.
Patients with prostate cancer were assessed before or within 21 days of starting ADT (n = 58) and 6 and 12 months later. Age- and education-matched patients with prostate cancer treated with prostatectomy only (n = 84) and men without prostate cancer (n = 88) were assessed at similar intervals. Participants provided baseline blood samples for genotyping. Mean-level cognitive performance was compared using mixed models; cognitive impairment was compared using generalized estimating equations.
ADT recipients demonstrated higher rates of impaired cognitive performance over time relative to all controls (P = .01). Groups did not differ at baseline (P > .05); however, ADT recipients were more likely to demonstrate impaired performance within 6 and 12 months (P for both comparisons < .05). Baseline age, cognitive reserve, depressive symptoms, fatigue, and hot flash interference did not moderate the impact of ADT on impaired cognitive performance (P for all comparisons ≥ .09). In exploratory genetic analyses, GNB3 single-nucleotide polymorphism rs1047776 was associated with increased rates of impaired performance over time in the ADT group (P < .001).
Men treated with ADT were more likely to demonstrate impaired cognitive performance within 6 months after starting ADT relative to matched controls and to continue to do so within 12 months after starting ADT. If confirmed, findings may have implications for patient education regarding the risks and benefits of ADT.
Incidence of skin cancer has been increasing among U.S. Hispanics, who often are diagnosed with larger lesions and at later stage disease. Behaviors to decrease exposure to ultraviolet radiation can ...reduce risk of skin cancer. We describe skin cancer prevention behaviors and psychosocial variables among Hispanic participants recruited into a skin cancer prevention trial.
Self-reported Hispanic participants from eight primary care clinics in Tampa, Florida and Ponce, Puerto Rico were recruited into a randomized controlled prevention trial. Information on demographics, sun-related behaviors, and psychosocial variables were collected before intervention materials were provided. Multivariable regression models were used to compare baseline sun-related behaviors and psychosocial variables across groups defined by geographic location and language preference.
Participants reported low levels of intentional outdoor tanning, weekday and weekend sun exposure, and very low levels of indoor tanning. However, only a minority of participants practiced sun-protective behaviors often or always, and about 30% experienced a sunburn in the past year. Participants had low levels of recent worry and concern about skin cancer, modest levels of perceived risk and severity, and high levels of response efficacy and self-efficacy. When comparing across groups defined by geographic location and language preference, English-preferring Tampa residents (hereafter referred to as Tampeños) had the highest proportion who were sunburned (35.9%) and tended toward more risky behavior but also had higher protective behavior than did Spanish-preferring Tampeños or Puerto Ricans. Spanish-preferring Puerto Ricans had higher recent concern about skin cancer, comparative chance of getting skin cancer, and response efficacy compared to either English- or Spanish-preferring Tampeños. Spanish-preferring Tampeños had the highest levels of familism and recent distress about skin cancer.
Our results mirror previous observations of low levels of sun-protective behavior among U.S. Hispanics compelling the need for culturally appropriate and translated awareness campaigns targeted to this population. Because Hispanics in Tampa and Puerto Rico reported modest levels of perceived risk and severity, and high levels of response efficacy and self-efficacy, interventions aiming to improve skin cancer prevention activities that are anchored in Protection Motivation Theory may be particularly effective in this population subgroup.
Augmented reality (AR) is a rapidly developing technology that has substantial potential as a novel approach for addiction treatment, including tobacco use. AR can facilitate the delivery of cue ...exposure therapy (CET) such that individuals can experience the treatment in their natural environments as viewed via a smartphone screen, addressing the limited generalizbility of extinction learning. Previously, our team developed a basic AR app for smoking cessation and demonstrated the necessary mechanisms for CET. Specifically, we showed that the AR smoking cues, compared to neutral cues, elicited substantial cue reactivity (i.e. increased urge) and that repeated exposure to the AR smoking cues reduced urge (i.e. extinction) in a laboratory setting. Here we report the next step in the systematic development of the AR app, in which we assessed the usability and acceptability of the app among daily smokers in their natural environments.
Daily smokers (N = 23, 78.3% female, Mean Age = 43.4, Mean Cigarettes/Day = 14.9), not actively quitting, were instructed to use the AR app in locations and situations where they smoke (e.g. home, bar) at least 5 times per day over one week. The study is registered in clinicaltrials.gov (NCT04101422).
Results indicated high usability and acceptability. Most of the participants (73.9%) used the AR app on at least 5 days. Participants found the AR cues realistic and well-integrated in their natural environments. The AR app was perceived as easy to use (Mean = 4.1/5) and learn (mean of 2 days to learn). Overall satisfaction with the app was also high. Secondary analyses found that 56.5% reported reduced smoking, with an average 26% reduction in cigarettes per day at follow-up.
These findings set the stage for a randomized controlled trial testing the AR app as an adjuvant therapy for treating tobacco dependence, with potential applicability to other substances.
KEY MESSAGE
This study found that the augmented reality (AR) smartphone application that utlized cue exposure treatment for smoking cessation was perceived as easy to use and learn in the natural, day-to-day environment of daily smokers. Findings set the stage for a larger clinical trial testing the AR app as an adjuvant therapy for treating tobacco dependence, with potential applicability to other addictive behaviors.
Background
This study examined repeat colorectal cancer screening rates at 12 and 24 months as part of a randomized intervention trial among Black persons living in the United States and factors ...associated with screening adherence.
Methods
Participants completed a survey assessing demographics and Preventive Health Model (PHM) factors (e.g., self efficacy, susceptibility) and received either a culturally targeted photonovella plus free fecal immunochemical test (FIT) kits (intervention group) or a standard educational brochure plus free FIT kits (comparison group). FIT return was assessed at 6, 12, and 24 months. Descriptive statistics summarized patterns of repeat screening. Logistic regression models assessed FIT uptake overtime, and demographic and PHM factors associated with screening adherence.
Results
Participants (N = 330) were U.S.‐born (93%), non‐Hispanic (97%), and male (52%). Initial FIT uptake within 6 months of enrollment was 86.6%, and subsequently dropped to 54.5% at 12 months and 36.6% at 24 months. Higher FIT return rates were observed for the brochure group at 24 months (51.5% vs 33.3% photonovella, p = .023). Multiple patterns of FIT kit return were observed: 37% completed FIT at all three time points (full adherence), 22% completed two of three (partial adherence), 29% completed one of three (partial adherence), and 12% did not return any FIT kits (complete nonadherence). Predictors of full adherence were higher levels of education and self‐efficacy.
Conclusions
Full adherence to repeat screening was suboptimal. Most participants had partial adherence (one or two of three) to annual FIT screening. Future studies should focus on strategies to support repeat FIT screening.
Findings indicate that adherence to repeat colorectal cancer screening was suboptimal, with only approximately 37% of study participants completing all three annual fecal immunochemical test screenings, and 22% completing two of three. Full adherence to screening was associated with higher levels of self‐efficacy and higher educational attainment.
•A multi-component JITAI was delivered to individuals attempting to quit smoking.•Delivery of brief mindfulness/motivational strategies was generally feasible.•Mindfulness strategies for smoking ...cessation were perceived as highly acceptable.
Smoking cessation treatments that are easily accessible and deliver intervention content at vulnerable moments (e.g., high negative affect) have great potential to impact tobacco abstinence. The current study examined the feasibility and acceptability of a multi-component Just-In-Time Adaptive Intervention (JITAI) for smoking cessation. Daily smokers interested in quitting were consented to participate in a 6-week cessation study. Visit 1 occurred 4 days pre-quit, Visit 2 was on the quit day, Visit 3 occurred 3 days post-quit, Visit 4 was 10 days post-quit, and Visit 5 was 28 days post-quit. During the first 2 weeks (Visits 1–4), the JITAI delivered brief mindfulness/motivational strategies via smartphone in real-time based on negative affect or smoking behavior detected by wearable sensors. Participants also attended 5 in-person visits, where brief cessation counseling (Visits 1–4) and nicotine replacement therapy (Visits 2–5) were provided. Outcomes were feasibility and acceptability; biochemically-confirmed abstinence was also measured. Participants (N = 43) were 58.1 % female (AgeMean = 49.1, mean cigarettes per day = 15.4). Retention through follow-up was high (83.7 %). For participants with available data (n = 38), 24 (63 %) met the benchmark for sensor wearing, among whom 16 (67 %) completed at least 60 % of strategies. Perceived ease of wearing sensors (Mean = 5.1 out of 6) and treatment satisfaction (Mean = 3.6 out of 4) were high. Biochemically-confirmed abstinence was 34 % at Visit 4 and 21 % at Visit 5. Overall, the feasibility of this novel multi-component intervention for smoking cessation was mixed but acceptability was high. Future studies with improved technology will decrease participant burden and better detect key intervention moments.
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