BackgroundDue to the colonization of tobacco plants by European settlers and the subsequent intensive marketing of commercial tobacco products to American Indian and Alaska Native (AI/AN) communities in the United States, commercial cigarette smoking accounts for half of all deaths among AI/AN people. Limited awareness, access to treatment, and the absence of culturally relevant, effective smoking cessation interventions contribute to these high death rates. ObjectiveThis study aims to culturally adapt iCanQuit, a smartphone smoking cessation app proven efficacious for the general population, for AI/AN people. MethodsA user-centered and community-based participatory research (CBPR) mixed methods approach was applied to culturally adapt iCanQuit for AI/AN people in collaboration with a community advisory board (CAB) of AI/AN individuals using a 3-step process. Step 1 identified ways to culturally adapt the iCanQuit for AI/AN people through 1-on-1 qualitative interviews with 8 prior iCanQuit AI/AN participants. Step 2 involved developing prototypes of cultural refinements identified in step 1 through regular biweekly meetings of the CAB, research, and app development teams. The prototypes were then evaluated with a separate group of 4 prior iCanQuit AI/AN participants through 1-on-1 qualitative interviews. Step 3 involved beta testing the app through a 6-day diary study followed by 1-on-1 qualitative interviews with a nationally recruited group of 7 AI/AN adults who smoke commercial cigarettes. The development work associated with step 3 was further informed by the CAB and the research and app development teams. ResultsKey findings identified 5 cultural refinements that informed subsequent app development and testing: (1) stories featuring AI/AN adults and elders emphasizing culture, spirituality, family, and community; (2) honoring the Earth as a motivator for cessation; (3) a guide character representative of AI/AN people; (4) clear distinction between ceremonial and commercial tobacco use; and (5) use of earth tones in visual design. In Step 3, all 7 (100%) diary study participants rated the beta version of the app as excellent or good/meets expectations (5/7, 71%, and 2/7, 29%, respectively) and that it felt made for them. They suggested 6 modifications which were incorporated into the final version of the app: (1) include vaping frequently asked questions, (2) feature motivation icons more prominently, (3) increase notification frequency, (4) track today’s cigarettes rather than yesterday’s, (5) allow users to update how much they spend per pack of cigarettes; and (6) rename the medications tool to reflect the inclusion of AI/AN traditional healing modalities. ConclusionsA user-centered and CBPR development process yielded IndigeQuit—one of the first known apps developed specifically to help AI/AN adults quit commercial cigarette smoking. Trial RegistrationClinicalTrials.gov NCT06145763; https://clinicaltrials.gov/ct2/show/NCT06145763

Objectives:Remote biochemical verification of smoking abstinence is limited by low adherence rates and technical problems with test completion. Qualitative data from study participants about their experiences completing these remote tests is lacking. The objectives were to interview participants who provided biochemical verification in a randomized trial of a smoking cessation intervention to (1) learn about participants' actual experiences with cotinine saliva testing; (2) examine willingness to conduct smartphone app-based carbon monoxide (CO) breathalyzer testing; and (3) gather recommendations to minimize barriers and improve adherence. Methods:Participants who completed biochemical verification were invited to participate in semi-structured interviews that included watching an instructional video about the breathalyzer test. Audio recordings were professionally transcribed, and 2 independent coders applied an interactive inductive thematic analysis approach. Results:Ten participants, ages 38.7 (9.5) years (30% male) completed interviews. Barriers to successful saliva cotinine testing included: technical issues submitting results (56%), issues following written instructions (44%), saliva collection sponge discomfort (33%), confusion about invalid results (33%), and concerns with device safety/data usage (22%). While more participants said they would, in concept, prefer the CO test or had no preference, they reported more problems with completing the CO test, including potential inaccessibility for people with respiratory illness. Key recommendations for improving compliance included: increasing monetary incentives, diversifying reminders, amplifying reciprocity messaging, managing expectations, and embedding clear, concise in-app guidance. Conclusion:Results suggest that compliance with remote biochemical verification can be improved through a comprehensive approach that includes increasing incentives, managing expectations, streamlining visual instructions, and diversifying reminders.

BackgroundUS veterans with mental health disorders have high rates of smoking and low rates of smoking cessation. ObjectiveThis study aims to focus on an adaptation of a web-based acceptance and commitment therapy (ACT) tobacco cessation intervention (Vet WebQuit) for veterans with mental health disorders who use tobacco and used a qualitative approach to test its usability (n=16). MethodsParticipants were asked to walk through the site during laboratory-based usability testing and “think aloud” about the features of the intervention. A trained facilitator used semistructured interview questions to assess participants’ experiences with Vet WebQuit and obtain feedback on their impressions of the site. Qualitative analyses identified themes regarding participants’ experiences with the intervention, usability concerns, and recommendations for improving Vet WebQuit. ResultsOverall, veterans found that the Vet WebQuit layout was simple and easy to navigate and use. Veterans reported that several features of the program were useful, including the quit plan, identification of triggers, content that targets mental health concerns (eg, dealing with anger), information on the health effects of smoking, tools for managing triggers (eg, urge surfing), and involving others in their quit plan. Veterans reported that particular features of the ACT approach for tobacco cessation were appealing to them, including the distinction between internal and external smoking triggers, the inclusion of the serenity prayer, and mindfulness exercises, which they could use as a tool reduce the intensity of cravings. Veterans reported wanting more information on the health aspects of smoking (ie, effects on breathing and lung capacity) as a way to motivate them to quit smoking. In addition, they suggested targeting specific mental health concerns that serve as triggers for smoking, including nightmares, boredom, and social isolation. ConclusionsOverall, results from this project identified important elements of ACT digital tobacco cessation interventions for veterans with mental health disorders.

Black/African American (hereafter Black) adults in the United States (US) who smoke cigarettes experience tobacco disparities. Although there are established associations between smoking and anxiety in the general population, past work has not explored these associations among Black adults who smoke. The present investigation examined Black adults who smoke combustible cigarettes who did and did not screen positive for an anxiety disorder (defined as a score of > 8 on the Overall Anxiety Severity and Impairment Norman et al., (J Psychiatric Res 45:262–268, 2011) in terms of perceived barriers for smoking cessation, severity of symptoms when trying to quit, and smoking abstinence expectancies. Exploratory tests were also conducted on secondhand smoke exposure. The current sample included 517 Black individuals who reported daily cigarette smoking (five or more cigarettes per day; mean age of 45 years, 51.5

Background Due to limited access to evidence-based cessation support, American Indian and Alaska Native (AI/AN) adults are half as likely to quit commercial cigarette smoking as other racial and ethnic groups. Geographical barriers, underfunded health systems, and limited integration of cessation services into routine care have reduced access to effective treatment in AI/AN communities. These challenges are compounded by a lack of culturally relevant interventions tailored to AI/AN adults. Thus, there is an urgent need for accessible, scalable, and culturally relevant interventions. Objective Here, we describe the protocol for a randomized clinical trial (RCT) testing the efficacy of a culturally adapted smoking cessation app (IndigeQuit) developed specifically to help AI/AN adults quit smoking commercial cigarettes compared to a standard, nontailored app (QuitGuide). Methods To improve the relevance and acceptability of cessation support to AI/AN adults, IndigeQuit was developed through a cultural adaptation of iCanQuit, an evidence-based smartphone app grounded in acceptance and commitment therapy that teaches skills for accepting cravings to smoke. The cultural adaptation used a user-centered, community-based participatory research mixed methods approach in collaboration with a community advisory board (CAB) comprising AI/AN individuals. Cultural adaptations included the use of Native imagery; stories featuring AI/AN adults and elders emphasizing culture, spirituality, family, and community; and the important distinction between ceremonial and commercial tobacco. A total of 776 AI/AN adults who smoke and want to quit are being recruited nationwide and randomized to receive IndigeQuit or QuitGuide for 12 months. The primary aim of the RCT is to determine the efficacy of IndigeQuit compared with QuitGuide for 30-day abstinence at 12 months. Secondary aims include abstinence at earlier time points, identifying mediators and moderators of treatment effects, and assessing engagement and satisfaction. Qualitative interviews with IndigeQuit participants and CAB members will inform the development of a subsequent guide to support the broad dissemination of IndigeQuit nationwide. Results The National Cancer Institute funded this study in 2024 (grant R01 CA284687), with the grant awarded to the principal investigator, JBB. As of August 2026, a total of 590 AI/AN adults had been enrolled in the trial. Data collection started in July 2025 and is expected to be completed by November 2028. Conclusions The IndigeQuit app was designed to deliver evidence-based smoking cessation treatment that is culturally adapted to AI/AN communities and grounded in acceptance and commitment therapy. If effective, this intervention could offer a more scalable and culturally relevant treatment to AI/AN communities nationwide, helping to reduce smoking-related health inequities. Trial Registration ClinicalTrials.gov NCT06145763; https://clinicaltrials.gov/study/NCT06145763 International Registered Report Identifier (IRRID) DERR1-10.2196/102675

The aim of the study was to validate the 30-item version of the Multidimensional Experiential Avoidance Questionnaire (MEAQ-30) in a sample of individuals who smoke combustible cigarettes and to examine the relationship between nicotine dependence, cigarette smoking, and experiential avoidance. Confirmatory factor analysis (CFA) was used to verify the structure of the MEAQ-30 and to test measurement invariance in a general population sample (n = 1040) and a sample of individuals who smoke combustible cigarettes (n = 550). Correlation and regression analyses were performed in a sample of individuals who smoke combustible cigarettes (n = 242) to evaluate the stability, dependability, convergent validity, discriminant validity, predictive validity and incremental predictive validity of the measure. The MEAQ-30 demonstrated adequate model fit and met criteria for measurement invariance. It exhibited good internal consistency, good stability, good discriminant validity, weak incremental predictive validity, and lower than expected levels of dependability. Based on our findings, the MEAQ-30 appears to be a valid measure of experiential avoidance in individuals who smoke combustible cigarettes.

Despite substantial health benefits, smoking cessation attempts have high relapse rates. Neuroimaging measures can sometimes predict individual differences in substance use phenotypes – including relapse – better than behavioral metrics alone. No study to date has compared the relative prediction ability of changes in psychological processes across prolonged abstinence with corresponding changes in brain activity. Here, in a longitudinal design, measurements were made one day prior to smoking cessation, and at 1 and 4 weeks post-cessation (total n=120). Next, we tested the relative role of changes in psychosocial variables vs. task-based functional brain measures predicting time to nicotine relapse up to 12 months. Abstinence was bioverified 4-5 times during the first month. Data were analyzed with a novel machine learning approach to predict relapse. Results showed that increased electrophysiological brain activity during inhibitory control predicted longer time-to-relapse (c-index=0.56). However, reward-related brain activity was not predictive (c-index=0.45). Psychological variables, notably an increase during abstinence in psychological flexibility when experiencing negative smoking-related sensations, predicted longer time-to-relapse (c-index=0.63). A model combining psychosocial and brain data was predictive (c-index=0.68). Using a best-practice approach, we demonstrated generalizability of the combined model on a previously unseen holdout validation dataset (c-index=0.59 vs. 0.42 for a null model). These results show that changes during abstinence – increased smoking-specific psychological flexibility and increased inhibitory control brain function – are important in predicting time to relapse from smoking cessation. In the future, monitoring and augmenting changes in these variables could help improve the chances of successful nicotine smoking abstinence.

OBJECTIVE:Delivering a single-session treatment digitally can offer increased accessibility. We developed and tested a single-session digital intervention for binge-eating disorder (BED) combining cognitive behavioural therapy (CBT) and mindfulness training. METHOD:English-speaking adults who met criteria for BED were recruited nationally. Participants completed a 60-min digital single-session intervention for BED. Our primary outcome was to evaluate initial acceptability (usability, overall satisfaction, engagement, visual appeal of content, understandability of programme material, desire to continue the programme, and overall helpfulness) and feasibility (intervention completion). We also evaluated changes in binge eating episodes, assessed via the Eating Disorder Examination Questionnaire (EDE-Q) objective binge eating episodes question, and eating disorder symptoms, assessed via the EDE-Q and Binge Eating Scale (BES). Acceptability measures were administered immediately after the completion of the digital module, while the BES and EDE-Q were administered at pre-treatment and at 1-month follow-up. RESULTS:All participants (N = 21) completed the intervention. Ratings for acceptability were excellent, with averages above a four on a five-point Likert scale on ratings for all dimensions. Participants reported large and significant decreases in binge eating episodes (d = 0.86) and BES scores (d = 0.91) as well as medium and significant decreases in global eating disorder symptoms at 1-month follow-up (d = 0.55). DISCUSSION:Results from this pilot suggest promising acceptability and feasibility for a single session of Mindful Courage for BED. This single session also appears to be preliminarily efficacious in reducing binge eating.

BackgroundHispanic adults receive less advice to quit smoking and use fewer evidence-based smoking cessation treatments compared to their non-Hispanic counterparts. Digital smoking cessation interventions, such as those delivered via smartphone apps, provide a feasible and within-reach treatment option for Hispanic adults who smoke and want to quit smoking. While the combination of pharmacotherapy and behavioral interventions are considered best practices for smoking cessation, its efficacy among Hispanic adults, especially alongside smartphone app–based interventions, is uncertain. ObjectiveThis secondary analysis used data from a randomized controlled trial that compared the efficacy of 2 smoking cessation apps, iCanQuit (based on acceptance and commitment therapy) and QuitGuide (following US clinical practice guidelines), to explore the association between pharmacotherapy use and smoking cessation outcomes among the subsample of 173 Hispanic participants who reported on pharmacotherapy use. Given the randomized design, we first tested the potential interaction of pharmacotherapy use and intervention arm on 12-month cigarette smoking abstinence. We then examined whether the use of any pharmacotherapy (ie, nicotine replacement therapy [NRT], varenicline, or bupropion) and NRT alone augmented each app-based intervention efficacy. MethodsParticipants reported using pharmacotherapy on their own during the 3-month follow-up and cigarette smoking abstinence at the 12-month follow-up via web-based surveys. These data were used (1) to test the interaction effect of using pharmacotherapy to aid smoking cessation and intervention arm (iCanQuit vs QuitGuide) on smoking cessation at 12 months and (2) to test whether the use of pharmacotherapy to aid smoking cessation augmented the efficacy of each intervention arm to help participants successfully quit smoking. ResultsThe subsample of Hispanic participants was recruited from 30 US states. They were on average 34.5 (SD 9.3) years of age, 50.9% (88/173) were female, and 56.1% (97/173) reported smoking at least 10 cigarettes daily. Approximately 22% (38/173) of participants reported using pharmacotherapy to aid smoking cessation at the 3-month follow-up, including NRT, varenicline, or bupropion, with no difference between intervention arms. There was an interaction between pharmacotherapy use and intervention arm that marginally influenced 12-month quit rates at 12 months (P for interaction=.053). In the iCanQuit arm, 12-month missing-as-smoking quit rates were 43.8% (7/16) for pharmacotherapy users versus 28.8% (19/16) for nonusers (odds ratio 2.21, 95% CI 0.66-7.48; P=.20). In the QuitGuide arm, quit rates were 9.1% (2/22) for pharmacotherapy users versus 21.7% (15/69) for nonusers (odds ratio 0.36, 95% CI 0.07-1.72; P=.20). Results were similar for the use of NRT only. ConclusionsCombining pharmacotherapy to aid smoking cessation with a smartphone app–based behavioral intervention that teaches acceptance of cravings to smoke (iCanQuit) shows promise in improving quit rates among Hispanic adults. However, this combined approach was not effective with the US clinical guideline–based app (QuitGuide). Trial RegistrationClinicalTrials.gov NCT02724462; https://clinicaltrials.gov/study/NCT02724462 International Registered Report Identifier (IRRID)RR2-10.1001/jamainternmed.2020.4055

BACKGROUND AND AIMS:Currently, smoking cessation intervention research on marginalized populations focuses on a single attribute (e.g. race). However, these attributes intersect and research on this intersectionality has been rare. This study applied latent class analysis (LCA) to examine how multiple theory-driven baseline factors interact and predict 12-month 30-day point prevalence abstinence from cigarette smoking in 2415 adult participants in a digital smoking cessation intervention. DESIGN:Theory-based analysis of a randomized trial with 12-month smoking cessation follow-up. SETTING:United States (US). PARTICIPANTS:A total of 2415 adults who smoke that were recruited from all 50 US states and enrolled in the trial between May 2017 and September 2018. INTERVENTION AND COMPARATOR:In the parent RCT, participants were randomized to receive iCanQuit, an Acceptance and Commitment Therapy-based smartphone smoking cessation app (n = 1214) or QuitGuide, a US Clinical Practice Guidelines-based smoking cessation app (n = 1201) for 12 months. MEASUREMENTS:Guided by Sheffer et al.,six theory-based factors were examined, including social identities: gender, race and ethnicity, marital status, sexual and gender minority (SGM) identity and socio-economic status (SES; education, income, employment); and lived experiences: positive screen for experiencing depression symptoms. Social identity and lived experiences data were collected via baseline questionnaires. The primary smoking cessation outcome was self-reported complete-case 30-day point prevalence abstinence at 12 months. SAS PROC LCA was used to identify classes based on the six selected factors and to predict 12-month smoking cessation. FINDINGS:A 4-class model showed the best goodness-of-fit statistics and interpretability. Participants in class 1 (n = 352, 14.6%) were more likely to be women, individuals of Black race and those with single marital status. Participants in class 2 (n = 322, 13.3%) were more likely to be men, SGM individuals and socioeconomically advantaged, as indicated by higher education, higher income or employment. Participants in class 3 (n = 368, 15.2%) were socioeconomically disadvantaged and screened positive for experiencing depression symptoms at baseline (CES-D ≥ 16). Finally, participants in class 4 (n = 1373, 56.9%) were more likely to be women, individuals of White race and married. Class 2 had the highest smoking cessation rate (32.8%) at 12 months, followed by class 1 (27.3%), class 4 (24.2%) and class 3 (15.4%). Compared with class 2, class 3 had 63% lower odds of quitting smoking (odds ratio = 0.37; 95% confidence interval = 0.20-0.71, P = 0.016). CONCLUSIONS:People with both socioeconomic disadvantage and symptoms of depression appear to have a harder time quitting smoking than other people who try to quit.

Background: Cigarette smoking is prevalent in many countries worldwide, especially in low-and middle-income countries (LMICs), presenting an urgent public health challenge. Disseminating freely available smoking cessation treatments that effectively decrease cigarette smoking globally is urgently needed. Objective: Identify the highest impact and most cost-effective values-based social media advertisements to disseminate our smoking cessation smartphone app, "iCanQuit", among adults living in 7 major cities of India. Values represented in the advertisements included family, relationships, self-care, health, and self-control. Using a quasi-experimental design, we aimed to determine (1) which values-based advertisements had the highest smoking cessation app dissemination reach, as measured by click-through rate (CTR), app installs, and app usage metrics; and (2) which values-based message advertisements were more cost-effective as measured by cost-per-impression, cost-per-click, and cost-per-install. The study population included a selected media market of individuals living in 7 metro cities of India-Delhi, Mumbai, Kolkata, Chennai, Bengaluru, Hyderabad, and Pune-who were exposed to one of 6 social media advertisements from January 16 to May 5, 2024. Methods: The advertisement campaign design for each of the identified values, based on previous smoking cessation trial data, followed a collaborative iterative process. Advertisements ran sequentially for 16 weeks. Advertisement exposure and app usage data were objectively collected via Google's Display & Video 360 advertisements campaign management and Firebase app development platforms. Advertisement exposure impact on app engagement was measured via several metrics, including click-through rate (CTR, ie, the likelihood of user clicks on an advertisement after seeing it), the number of app installs (ie, a user opening the app for the first time after downloading it), and the number of app sessions (ie, app usage). Cost efficiency was measured via cost per click and cost per install for each ad. Results: Overall, the CTR was 5%. The app was installed 5111 times. The average cost per click and cost per app install across all advertisements were US $ 0.006 and US $ 6.43, respectively. The advertisements with the lowest cost per install (range: US $4.83-US $5.16) and highest CTR (between 6% and 9%) focused on the values of family, health, and self-control. Advertisements focused on the values of relationships and self-care had modestly higher levels of engagement. Conclusions: Advertisements focusing on the values of family, health, and self-control had the highest potential reach at the lowest cost. Overall, these findings provide insights into the reach and cost-effectiveness of values-based messages in social media advertisements, guiding future outreach efforts for population-level dissemination of smoking cessation apps.

Introduction:Whether living near a tobacco retailer impacts the efficacy of smoking cessation treatments remains largely unknown. We used data from a randomized trial comparing two smoking cessation apps among 2415 adults: iCanQuit, based on Acceptance and Commitment Therapy, and QuitGuide, based on standard U.S. Clinical Practice Guidelines. We examined whether tobacco retailer density impacted the efficacy of the treatments on 12-month cessation outcomes. Methods:Data on tobacco retailer density per 1,000 people (i.e., "one unit") was linked to each participant's residential ZIP Code. Cessation outcomes included 30-day point prevalence abstinence (PPA) from cigarette smoking, prolonged abstinence, 30-day PPA from nicotine/tobacco products, and relapse. We examined the interaction between density and treatment arm on 12-month 30-day PPA and compared cessation outcomes separately by arm. Results:The interaction between density and treatment arm on cessation did not reach statistical significance (P = 0.09). For each one-unit increase in density, there was no change in quit rates in the iCanQuit arm (P = 0.62). In the QuitGuide arm, higher density was associated with lower quit rates (OR = 0.54; 95 % CI, 0.27-1.06; P = 0.07), although not-statistically significant. There was a significant interaction between density and treatment arm on prolonged cigarette abstinence (P = 0.03). We found no change in prolonged abstinence in the iCanQuit arm (P = 0.44). In the QuitGuide arm, higher density was associated with lower prolonged abstinence (OR = 0.27; 95 % CI, 0.07-1.02; P = 0.054), although not-statistically significant. Conclusions: Living near tobacco retailers may undermine the effectiveness of standard behavioral treatment but appears to have no impact on the effectiveness of acceptance-based smoking cessation treatments.

Hispanic individuals experience significant health disparities related to smoking. Research focused on the methods employed to quit smoking among the Hispanic population is needed to better understand how to increase engagement with evidence-based smoking cessation guidelines and mitigate smoking-related health disparities. The present investigation sought to: (1) document smoking cessation methods used in previous quit attempts, including Nicotine Replacement Therapy (NRT), and (2) test group differences (NRT use vs not) in smoking-related vulnerability processes (i.e., cigarette dependence, perceived barriers for smoking cessation, severity of problems when trying to quit, and number of prior failed quit attempts). Participants were recruited nationally throughout the United States via Qualtrics Panels and were 302 Hispanic adults (38.1

Ao longo de sua história, a estratégia e as táticas da pesquisa em ciência compor­tamental contextual (CBS) têm apresentado características distintas em comparação com as abordagens tradicionais da ciência do comportamento. O progresso contínuo da pesquisa em CBS pode ser favorecido por uma maior clareza sobre como sua estratégia e táticas podem ser aplicadas aos desafios atuais. O presente relatório branco (white paper) é o resultado de um longo processo de 2 1/2 anos, concebido para fomentar o consenso entre representantes produtores e consumidores da pesquisa em CBS sobre o melhor caminho estratégico a seguir. O Grupo de Trabalho concordou que a pesquisa em CBS deve ser multinível, baseada em processos, multidimensional, pró-social e pragmática, e apresentou 33 recomendações para a comunidade de CBS organizadas segundo essas características. Em essência, este relatório fornece uma agenda de pesquisa detalhada projetada para maximizar o impacto da CBS como campo científico. Cientistas e profissionais são incentivados a assumir essa ambiciosa agenda.

Due to the colonization of tobacco plants by European settlers and the subsequent intensive marketing of commercial tobacco products to American Indian and Alaska Native (AI/AN) communities in the U.S., commercial cigarette smoking accounts for half of all deaths among AI/AN people. Lack of awareness, access to treatment, and the absence of culturally relevant, effective smoking cessation interventions contribute to these high death rates. To culturally adapt iCanQuit, a smartphone smoking cessation application (“app”) proven efficacious for the general population, for AI/AN people. A user-centered and community-based participatory research (CBPR) mixed-methods approach was applied to culturally adapt iCanQuit for AI/AN people in collaboration with a community advisory board (CAB) of AI/AN individuals using a three-step process between June/2024 and August/2025. Step 1 identified ways to culturally adapt the iCanQuit for AI/AN people through one-on-one qualitative interviews with eight prior iCanQuit AI/AN participants. Step 2 involved developing prototypes of cultural refinements identified in Step 1 through regular bi-weekly meetings of the CAB, research and app development teams. The prototypes were then evaluated with a separate group of four prior iCanQuit AI/AN participants through one-on-one qualitative interviews. Step 3 involved beta testing the app through a six-day diary study followed by one-on-one qualitative interviews with a nationally recruited group of seven AI/AN adults who smoke commercial cigarettes. The development work associated with Step 3 was further informed by the CAB and the research and app development teams. Step 1 yielded five suggested cultural refinements to iCanQuit that were subsequently developed and tested in Steps 2 and 3: (1) modify the app’s stories to feature AI/AN adults and elders who quit smoking, emphasizing the values of culture, spirituality, family, and community as motivators; (2) add the value of honoring the Earth as a motivator to quit smoking; (3) make the appearance of the app’s “guide” character more representative of AI/AN people; (4) add information distinguishing ceremonial vs. commercial tobacco use; and (5) use earth tones in the app’s colors. In Step 3, 100% of diary study participants rated the beta version of the app as excellent or good/meets expectations (69% and 31%, respectively) and that it felt made for them. They suggested six modifications which were incorporated into the final version of the app: (1) include a vaping FAQ, (2) feature motivation icons more prominently, (3) increase notification frequency, (4) track today’s cigarettes rather than yesterday’s, (5) allow users to update how much they spend per pack of cigarettes; and (6) rename the medications tool to reflect the inclusion of AI/AN traditional healing modalities. A user-centered and CBPR development process yielded IndigeQuit—one of the first known apps developed specifically to help AI/AN adults quit commercial cigarette smoking. ClinicalTrials.gov Identifier, NCT06145763

Behavioral clinical trials among cancer patients often fail to meet recruitment goals - especially for underrepresented groups. Comparing recruitment strategies on participant accrual and cost can inform the use of cost-effective recruitment strategies for enrollment of diverse populations of cancer patients. In this study, we compared social media, internet sites, and clinic-based recruitment on accrual, cost, and characteristics of cancer patients (i.e., sociodemographic, cancer type/stage, and smoking habits) enrolled in a randomized trial of app-based smoking cessation interventions. Fisher's exact tests for categorical variables and analysis of variance for continuous variables were used to compared data between recruitment strategies. In 35 months, 427 cancer patients from 45 US states enrolled in the trial out of 3,936 screened (rate of participation, 10.8%). Social media recruited over eight times the number of enrolled participants (n=340, 79.6%) compared with Internet sites (n=43, 10.1%) and clinics (n=42, 9.8%). Most (80.1%) participants were women, with mean age 52.3 years. About 20.4% of participants were from underrepresented racial/ethnic backgrounds, 23.0% were rural residents, and 23.7% were uninsured. Over 32 cancer types and all cancer stages were represented. Breast cancer was the most common diagnosis (n=129/427, 30.2%), followed by lung cancer (n=96/427, 23.8%). Internet recruitment generated a higher proportion of men (30.2% vs. 26.2% clinics vs. 17.4% social media, P=.005). Clinics generated a higher proportion of Hispanic participants (9.5% vs. 7.0% Internet vs. 2.6% social media, P=.04) and cancer patients aged 65 and older (28.6% vs. 11.5% social media vs. 4.7% Internet, P=.01). Social media recruited a higher proportion of participants with low income (<$20,000: 39.1% vs. 23.3% Internet vs. 19.0% clinics, P<.001), who tended to have later stage cancers (stage IV: 17.4% vs. 14.0% Internet vs. 7.1% clinics, P=.05). Cost per randomized participant ranged from $270 via social media to $454 via Internet sites to $2,240 via clinic-based recruitment. In conclusion, social media was the most efficient and cost-effective method for recruiting a quality sample of racially/ethnically, geographically, socioeconomically, and clinically diverse sample of cancer patients into a smoking cessation clinical trial. Social media has solid potential for recruiting cancer patients into behavioral clinical trials.

Fatigue's interference with activities, mood, and cognition is one of the most prevalent and distressing problems of patients with advanced gastrointestinal cancer. As fatigue interferes with patient functioning, family caregivers often report feeling burdened by increasing demands. Evidence-based interventions for patient fatigue interference and caregiver burden are lacking in advanced gastrointestinal cancer. In a pilot trial, telephone-based Acceptance and Commitment Therapy (ACT) showed potential for reducing patient fatigue interference and caregiver burden in this population. The current Phase II trial seeks to determine the efficacy of this intervention for patients with advanced gastrointestinal cancer and moderate-to-severe fatigue interference and their family caregivers with significant caregiving burden. In this trial, 244 dyads are randomly assigned to either the ACT intervention or an education/support control. Participants in both conditions attend six weekly 50-min telephone sessions, four of which involve both dyad members, and a 30-min booster session. The primary aim is to test the effects of telephone-delivered ACT on patient fatigue interference and caregiver burden. Secondary outcomes include patient sleep interference and patient and caregiver engagement in daily activities and quality of life. Outcomes are assessed at baseline, 2 weeks post-intervention, and 3 months post-intervention. This trial also examines whether increased psychological flexibility, defined as mindful acceptance of present experiences, including challenges, while pursuing actions aligned with personal values, mediates ACT's effects on primary outcomes. Our ability to demonstrate ACT's efficacy will support its adoption in cancer care. Findings will also inform future ACT trials for dyads coping with other serious illnesses. Trial Registration ID: NCT06532877.

Cancer poses significant challenges for patients and caregiving partners. Avoidant communication has been linked to poorer psychosocial adjustment to cancer. Two conceptual models have been proposed to account for this linkage: the social-cognitive processing and relationship intimacy models. Objective: To examine the utility of these models in explaining patient and partner psychological and relationship adjustment on a day-to-day basis using ecological momentary assessment. Method: Patients with breast, colorectal, or lung cancer and their partners (286 dyads) were prompted twice daily for 14 days via smartphone to answer questions about communication with their partner, adjustment (psychological distress and relationship satisfaction), and hypothesized mediators (avoidant thoughts and intimacy). Data were collected from 2017 to 2020. Results: Participants responded to 92% of prompts and completed 91%. Results supported the relationship intimacy but not the social-cognitive processing model. On afternoons when participants (both patients and caregivers) held back or perceived avoidance or criticism from their partner, they reported less intimacy, as did their partners; this lowered intimacy, in turn, led to participants' (both patients' and caregivers') own lowered relationship satisfaction that evening and to patients' lowered relationship satisfaction through caregivers' lowered intimacy (one-tailed Bayesian ps < .025). When distress was the criterion, patients' holding back or perceived avoidance/criticism led to their own increased distress through their own decreased intimacy, and caregivers' holding back or perceived avoidance/criticism led to patients' increased distress through patients' lowered intimacy (one-tailed Bayesian ps < .005). Conclusions: Findings offer implications for interventions designed to improve communication and enhance closeness.

BackgroundWhile smartphone apps for smoking cessation have shown promise for combustible cigarette smoking cessation, their efficacy in helping dual users of combustible and electronic cigarettes (e-cigarettes) to quit cigarettes remains unknown. This study utilized data from a randomized trial to determine if an Acceptance and Commitment Therapy (ACT)-based app (iCanQuit) was more efficacious than a US Clinical Practice Guidelines-based app (QuitGuide) for combustible cigarette smoking cessation among 575 dual users.MethodsThe primary cessation outcome was self-reported, complete-case 30-day abstinence from combustible cigarettes at 12 months. Logistic regression assessed the interaction between dual use and treatment arm on the primary outcome in the full trial sample (N = 2,415). We then compared the primary outcome between arms among dual users (iCanQuit: n = 297; QuitGuide: n = 178). Mediation analyses were conducted to explore mechanisms of action of the intervention: acceptance of cues to smoke and app engagement. Results: There was an interaction between dual use of combustible and e-cigarettes and treatment arm on the primary outcome (p = 0.001). Among dual users, 12-month abstinence from cigarettes did not differ between arms (23% for iCanQuit vs. 27% for QuitGuide, p = 0.40). Mediation analysis revealed a significant positive indirect effect of the iCanQuit app on 12-month abstinence from cigarettes through acceptance of emotions that cue smoking (p = 0.004).ConclusionsFindings from this study of dual users of combustible and e-cigarettes showed no evidence of a difference in quit rates between arms. Acceptance of emotions that cue smoking is a potential mechanism contributing to cigarette smoking abstinence among dual users.

PURPOSE:Fatigue is a highly prevalent and disabling symptom for patients with metastatic breast cancer (MBC). Evidence-based interventions for managing fatigue in advanced cancer populations are lacking. This phase II randomized controlled trial tested the effect of acceptance and commitment therapy (ACT) on fatigue interference with functioning in patients with MBC. METHODS:Eligible patients were women with stage IV breast cancer who had moderate to severe fatigue interference. Patients completed a baseline assessment that included self-report measures of fatigue interference with activities, mood, and cognition (primary outcome) and sleep interference with functioning, engagement in daily activities, and quality of life (QOL; secondary outcomes). Then patients were randomly assigned to six weekly telephone-delivered sessions of either ACT (n = 116) or education/support (n = 120). Follow-up assessments occurred at 2 weeks, 3 months, and 6 months postintervention (means, 9.69, 20.51, and 33.59 weeks postbaseline, respectively). RESULTS:Linear mixed model analyses showed that compared with patients in the education/support condition, patients in the ACT condition reported significantly less fatigue interference (P = .018). These results were significant at 2 weeks and 6 months postintervention. ACT's effect on sleep interference was not statistically significant after the Sidak adjustment for multiple comparisons (P = .037). ACT patients showed a steady decline in sleep interference, a trend that was not found for education/support patients. Engagement in daily activities and QOL did not significantly differ between study groups, except for functional QOL (P = .006). Compared with education/support patients, ACT patients showed significantly better functional QOL at 2 weeks and 6 months postintervention. CONCLUSION:Results suggest that a brief, telephone-delivered ACT intervention can reduce fatigue interference with functioning in patients with MBC.