Testing the Efficacy of a Scalable Telephone-Delivered Guided Imagery Tobacco Cessation Treatment: Protocol for a Randomized Clinical Trial.

BACKGROUND: Tobacco use continues to be a leading preventable cause of death and disease in the United States, accounting for >480,000 deaths each year. Although treatments for tobacco use are effective for many, there is substantial variability in outcomes, and these approaches are not effective for all individuals seeking to quit smoking cigarettes. New, effective therapeutic approaches are needed to meet the preferences of people who want to stop smoking. Guided imagery (GI) is a mind-body technique that involves the guided visualization of specific mental images, which is enhanced with other sensory modalities and emotions. Preliminary evidence provides initial support for the use of GI as a treatment for cigarette smoking. Meta-analyses have shown that standard treatment for cigarette smoking delivered over the telephone via quitlines is effective. A telephone-based intervention that uses GI might provide another effective treatment option and increase the reach and effectiveness of quitlines. OBJECTIVE: This study aims to test the efficacy of Be Smoke Free, a telephone-delivered GI treatment for smoking cessation. METHODS: This multisite randomized clinical trial (RCT) will compare a novel telephone-delivered GI tobacco cessation treatment with a standard evidence-based behavioral treatment. The study will be conducted over 5 years. In phase 1, we refined protocols and procedures for the New York State and West Virginia sites for use in the RCT. During phase 2, we will conduct an RCT with 1200 participants: 600 (50%) recruited via quitlines and 600 (50%) recruited via population-based methods. Participants will be randomly assigned to either the GI condition or the behavioral condition; both treatments will be delivered by trained study coaches located at the University of Arizona. Assessments will be conducted at baseline and 3 and 6 months after enrollment by University of Arizona research staff. The primary outcome will be self-reported 30-day point prevalence abstinence 6 months after enrollment. Secondary outcomes include biochemically verified 7-day point prevalence abstinence 6 months after enrollment. RESULTS: Recruitment in West Virginia and New York began in October 2022. As of March 31, 2023, a total of 242 participants had been enrolled. Follow-up assessments began in November 2022. As of March 31, 2023, of the 118 eligible participants, 97 (82.2%) had completed the 3-month assessment, and 93% (26/28) of eligible participants had completed the 6-month assessment. Biochemical verification and qualitative interviews began in April 2023. Recruitment will continue through 2025 and follow-up assessments through 2026. Primary results are expected to be published in 2027. CONCLUSIONS: The Be Smoke Free study is a first-of-its-kind RCT that incorporates GI into telephone-based tobacco cessation treatment. If successful, Be Smoke Free will have substantial benefits for the long-term health of people who use tobacco across the United States. TRIAL REGISTRATION: ClinicalTrials.gov NCT05277831; https://clinicaltrials.gov/ct2/show/NCT05277831. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/48898.

Tobacco Dependence Treatment in Oncology: Initial Patient Clinical Characteristics and Outcomes from Roswell Park Comprehensive Cancer Center.

Despite the importance of smoking cessation to cancer care treatment, historically, few cancer centers have provided treatment for tobacco dependence. To address this gap, the National Cancer Institute (NCI) launched the Cancer Center Cessation Initiative (C3i). As part of this effort, this study examined implementation outcomes in a cohort of cancer survivors (CSs) who smoked cigarettes in the first year of an ongoing process to develop and implement a robust Tobacco Treatment Service at Roswell Park Comprehensive Cancer Center. We provide a comprehensive description of the new tobacco use assessment and referral process, and of the characteristics of cancer survivors who agreed to treatment including traditional tobacco-related psychosocial and cancer treatment-related characteristics and novel characteristics such as delay discounting rates. We also examine characteristic differences among those who agreed to treatment between those who attended and those who did not attend treatment. As the new tobacco assessment was implemented, the number of referrals increased dramatically. The mean number of treatment sessions attended was 4.45 (SD = 2.98) and the six-month point prevalence intention to treat abstinence rate among those who attended was 22.7%. However, only 6.4% agreed to treatment and 4% attended at least one treatment session. A large proportion of cancer survivors who agreed to treatment were women, of older age, of lower socioeconomic status (SES), and who had high levels of depressive symptomology. The findings demonstrate that the implementation of system changes can significantly improve the identification of cancer survivors who use tobacco and are referred to tobacco use treatment. Among those who attend, treatment is effective. However, the findings also suggest that a systematic assessment of barriers to engagement is needed and that cancer survivors may benefit from additional treatment tailoring. We present plans to address these implementation challenges. Systematic electronic medical record (EMR)-sourced referral to tobacco treatment is a powerful tool for reaching cancer survivors who smoke, but more research is needed to determine how to enhance engagement and tailor treatment processes.

Electronic cigarette use among patients with cancer: characteristics of electronic cigarette users and their smoking cessation outcomes.

BACKGROUND: Given that continued smoking after a cancer diagnosis increases the risk of adverse health outcomes, patients with cancer are strongly advised to quit. Despite a current lack of evidence regarding their safety and effectiveness as a cessation tool, electronic cigarettes (E-cigarettes) are becoming increasingly popular. To guide oncologists' communication with their patients about E-cigarette use, this article provides what to the authors' knowledge is the first published clinical data regarding E-cigarette use and cessation outcomes among patients with cancer. METHODS: A total of 1074 participants included smokers (patients with cancer) who recently enrolled in a tobacco treatment program at a comprehensive cancer center. Standard demographic, tobacco use history, and follow-up cessation outcomes were assessed. RESULTS: A 3-fold increase in E-cigarette use was observed from 2012 to 2013 (10.6% vs 38.5%). E-cigarette users were more nicotine dependent than nonusers, had more prior quit attempts, and were more likely to be diagnosed with thoracic and head or neck cancers. Using a complete case analysis, E-cigarette users were as likely to be smoking at the time of follow-up as nonusers (odds ratio, 1.0; 95% confidence interval, 0.5-1.7). Using an intention-to-treat analysis, E-cigarette users were twice as likely to be smoking at the time of follow-up as nonusers (odds ratio, 2.0; 95% confidence interval, 1.2-3.3). CONCLUSIONS: The high rate of E-cigarette use observed is consistent with recent articles highlighting increased E-cigarette use in the general population. The current longitudinal findings raise doubts concerning the usefulness of E-cigarettes for facilitating smoking cessation among patients with cancer. Further research is needed to evaluate the safety and efficacy of E-cigarettes as a cessation treatment for patients with cancer.

Focal electrical stimulation as an effective sham control for active rTMS and biofeedback treatments.

A valid sham control is important for determining the efficacy and effectiveness of repetitive transcranial magnetic stimulation (rTMS) as an experimental and clinical tool. Given the manner in which rTMS is applied, separately or in combination with self-regulatory approaches, and its intended impact on brain states, a valid sham control of this type may well serve as a meaningful control for biofeedback studies, where efforts to develop a credible control have often been less than ideal. This study examined the effectiveness of focal electrical stimulation of the frontalis muscle as a sham technique for blinding participants to high-frequency rTMS over the dorso-lateral prefrontal cortex (DLPFC) at durations, intensities, and schedules of stimulation similar to many clinical applications. In this within-subjects single blind design, 19 participants made guesses immediately after receiving 54 counterbalanced rTMS sessions (sham, 10 Hz, 20 Hz); 7 (13 %) of the guesses were made for sham, 31 (57 %) were made for 10 Hz, and 16 (30 %) were made for 20 Hz. Participants correctly guessed the sham condition 6 % (CI 1, 32 %) of the time, which is less than the odds of chance (i.e., of guessing at random, 33 %); correctly guessed the 10 Hz condition 66 % (CI 43, 84 %) of the time, which was greater than chance; and correctly guessed the 20 Hz condition 41 % (CI 21, 65 %) of the time, which was no different than chance. Focal electrical stimulation therefore can be an effective sham control for high-frequency rTMS of the DLPFC, as well as for active biofeedback interventions. Participants were unaware that electrical stimulation was, in fact, sham rTMS.

A survey of tobacco-related knowledge, attitudes and behaviours of primary care providers in Mississippi.

RATIONALE: Relative to other regions in the USA, Mississippi has a high prevalence of tobacco use and tobacco-related disease. This study assessed the tobacco-related knowledge, attitudes and intervention behaviours of family doctors, dentists and nurse practitioners in the state of Mississippi. METHODS: The Provider Attitude Survey, an 85-item measure of tobacco-related knowledge, attitudes and intervention behaviours was mailed to all members of Mississippi's Family Medicine, Dentistry and Nurse Practitioner professional organizations (N=2043). RESULTS: Over one-third (n=802, 39.2%) of eligible providers responded. Just 24.3% had received training in tobacco cessation and 33.7% were aware of the Public Health Service clinical practice guideline. Over 90% indicated that it was their role to prevent tobacco use; felt rewarded when they helped patients quit; and were bothered and upset by the health effects of tobacco. Doctors assisted more patients than nurses or dentists. Doctors and nurses reported more self-efficacy, motivation and preparedness for treating tobacco use than dentists. Providers with training performed more interventions and reported more self-efficacy, preparedness and fewer barriers than those without training. Training was associated with greater increases in self-efficacy, preparedness and intervention behaviours for dentists than for the other groups. CONCLUSIONS: Despite a high prevalence of tobacco use and tobacco-related disease in Mississippi, primary care providers in Mississippi provide tobacco cessation interventions at an unacceptably low frequency relative to other regions. Training is likely to increase the frequency of intervention behaviours.