Videoconferencing Smoking Cessation Program for Smoking
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen ByStephanie L Marhefka, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of South Florida
Disqualifiers: Pregnant, Breastfeeding, Others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests a program to help people living with HIV stop smoking by using group video calls, nicotine patches, and quitting advice. The Positively Smoke Free (PSF) program is a biobehavioral cessation intervention specifically designed for people with HIV, with a growing evidence base.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that you should not be receiving other tobacco treatment.
What data supports the effectiveness of the treatment Positively Living, Positively Me, Positively Quit, Positively Me for smoking cessation?
The effectiveness of the treatment may be supported by research showing that digital and telephone-based smoking cessation programs, which provide frequent contact and support, can help people quit smoking. Additionally, positive reinforcement and individualized support are key components in successful smoking cessation strategies.
12345Is the Videoconferencing Smoking Cessation Program safe for humans?
There is no specific safety data available for the Videoconferencing Smoking Cessation Program, but general information on complementary and alternative medicine (CAM) suggests that while most CAM products and practices are considered low risk, there can be potential risks of interactions with conventional medicines and some adverse events have been reported, especially in children.
678910How is the Positively Living, Positively Me treatment for smoking cessation unique?
The Positively Living, Positively Me treatment is unique because it uses videoconferencing technology to deliver a smoking cessation program, making it accessible for people in rural or remote areas who can't attend in-person sessions. This approach allows for real-time support and interaction, similar to in-person counseling, but with the convenience of being at home.
13111213Eligibility Criteria
The Positively Quit Trial is for adults over 18 living in the US with certain chronic conditions who smoke cigarettes and are motivated to quit. Participants must have internet access, be able to use Zoom, speak English, and not be pregnant or breastfeeding. They cannot be using other tobacco treatments.Inclusion Criteria
You currently smoke cigarettes and have reported it yourself.
demonstrate the ability to connect to the HIPAA-compliant videoconferencing system, Zoom, over the internet
speak English
+8 more
Exclusion Criteria
I am not pregnant, breastfeeding, and have no issues with nicotine replacement therapy.
I can communicate clearly in English during video calls.
receiving other tobacco treatment
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2 weeks
1 visit (virtual)
Baseline Assessment
Participants complete a baseline assessment consisting of a secure online survey
1 week
1 visit (virtual)
Treatment
Participants receive brief cessation counseling, an offer of nicotine replacement therapy patches, and participate in 8 group sessions over 6 weeks
6 weeks
8 visits (virtual)
Booster Sessions
Participants attend booster sessions to reinforce smoking cessation strategies
12 weeks
4 visits (virtual)
Follow-up
Participants are monitored for smoking behavior and abstinence through assessments and cotinine swab tests
12 months
5 visits (virtual)
Participant Groups
This study tests a smoking cessation program delivered via videoconferencing against an Attention Matched Control condition that doesn't focus on quitting but has equal contact hours. Both groups get nicotine patches and advice to quit across 12 sessions.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Positively MeExperimental Treatment1 Intervention
Positively Me is a 12-session (8 \[1.5\] hour main sessions plus four booster sessions) intervention guided by Social Cognitive Theory to promote smoking cessation in people with certain health conditions.
Group II: Positively LivingPlacebo Group1 Intervention
Positively Living is a modified updated version of a healthy living intervention based on Social Cognitive Theory that is designed for people with certain health conditions and attention-matched to the experimental condition (8 \[1.5\] hour main sessions plus four booster sessions).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of South Florida, College of Public HealthTampa, FL
University of South Florida, College of NursingTampa, FL
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Who Is Running the Clinical Trial?
University of South FloridaLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Telephone-Based Coaching. [2022]Many Americans continue to smoke, increasing their risk of disease and premature death. Both telephone-based counseling and in-person tobacco cessation classes may improve access for smokers seeking convenient support to quit. Little research has assessed whether such programs are effective in real-world clinical populations.
Smoking cessation strategies and evaluation. [2019]The success of smoking cessation interventions appears to be most closely related to the amount of positive reinforcement that the smoker receives for not smoking (unpublished data). The goal of the clinic is to reinforce not smoking over the longest period of time. The program outlined focuses on helping the smoker who wants to stop smoking, it demands a minimal amount of time from the physician and it is self-supporting. If these guidelines are followed, the physician should find that helping the smokers who want help to stop smoking is a productive and rewarding experience.
A digital smoking cessation program delivered through internet and cell phone without nicotine replacement (happy ending): randomized controlled trial. [2022]Happy Ending (HE) is an intense 1-year smoking cessation program delivered via the Internet and cell phone. HE consists of more than 400 contacts by email, Web pages, interactive voice response, and short message service technology. HE includes a craving helpline and a relapse prevention system, providing just-in-time therapy. All the components of the program are fully automated.
Smoking cessation. [2017]Cigarette smoking is the primary cause of chronic obstructive pulmonary disease, and smoking cessation is the most effective means of stopping the progression of chronic obstructive pulmonary disease. Worldwide, approximately a billion people smoke cigarettes and 80% reside in low-income and middle-income countries. Though in the United States there has been a substantial decline in cigarette smoking since 1964, when the Surgeon General's report first reviewed smoking, smoking remains widespread in the United States today (about 23% of the population in 2001). Nicotine is addictive, but there are now effective drugs and behavioral interventions to assist people to overcome the addiction. Available evidence shows that smoking cessation can be helped with counseling, nicotine replacement, and bupropion. Less-studied interventions, including hypnosis, acupuncture, aversive therapy, exercise, lobeline, anxiolytics, mecamylamine, opioid agonists, and silver acetate, have assisted some people in smoking cessation, but none of those interventions has strong research evidence of efficacy. To promote smoking cessation, physicians should discuss with their smoking patients "relevance, risk, rewards, roadblocks, and repetition," and with patients who are willing to attempt to quit, physicians should use the 5-step system of "ask, advise, assess, assist, and arrange." An ideal smoking cessation program is individualized, accounting for the reasons the person smokes, the environment in which smoking occurs, available resources to quit, and individual preferences about how to quit. The clinician should bear in mind that quitting smoking can be very difficult, so it is important to be patient and persistent in developing, implementing, and adjusting each patient's smoking-cessation program. One of the most effective behavioral interventions is advice from a health care professional; it seems not to matter whether the advice is from a doctor, respiratory therapist, nurse, or other clinician, so smoking cessation should be encouraged by multiple clinicians. However, since respiratory therapists interact with smokers frequently, we believe it is particularly important for respiratory therapists to show leadership in implementing smoking cessation.
Mediated smoking cessation programs in the Stanford Five-City Project. [2019]Two mediated smoking cessation programs were subjected to a field evaluation. The Quit Kit is a printed self-help package, and "Calling It Quits" consists of five segments which were aired on the local television news. A sample of 239 persons requested the Quit Kit and were followed. At the 2-month and 12-month follow-ups, respectively, 13.6% and 17.9% of those surveyed reported abstinence. Results indicate the potential of mediated interventions.
Patterns and perceptions of complementary/alternative medicine among paediatricians and patients' mothers: a review of the literature. [2022]For many families and their children, the use of complementary/alternative medicine (CAM) is an accepted adjunct or alternative to conventional therapy, even if data available in the literature regarding risks and adverse drug reactions (ADRs) pertaining to childhood populations are scarce. Moreover, despite widespread and increasing use of CAM, there are limited data on how paediatricians communicate with mothers and/or patients about CAM. Therefore, we report the studies available in the literature in the paediatric field and summarise what is known about ADRs and risks of CAM, taking into account in particular problems related to interactions between phytotherapy and conventional medicines and to counselling.
Use of natural medicine and dietary supplements concomitant with conventional medicine among people with Multiple Sclerosis. [2021]The use of complementary and alternative medicine (CAM) are widespread among people with Multiple Sclerosis (PwMS) and are often used concomitant with conventional treatment. Natural medicine and dietary supplements (NADS) are the most frequently used CAM modality and among other patient groups use of NADS concomitant with conventional medicine has been reported as a potential risk to patients' safety due to risk of drug interactions. The use of NADS concomitant with conventional medicine has, however, not been investigated among PwMS. This study's aim was to investigate the prevalence of NADS and conventional MS-related medicine use among PwMS, specific types of NADS and conventional MS-related medicine used, the prevalence of NADS used concomitant with conventional MS-related medicine, and to characterize PwMS who use NADS and PwMS who use NADS concomitant with conventional MS-related medicine in a Danish context.
The other side of the coin: safety of complementary and alternative medicine. [2004]Most consumers consider complementary and alternative medicine (CAM) products inherently safe. The growing simultaneous use of CAM products and pharmaceutical drugs by Australian consumers increases the risk of CAM-drug interactions. The Therapeutic Goods Administration (TGA) has a two-tier, risk-based regulatory system for therapeutic goods - CAM products are regulated as low risk products and are assessed for quality and safety; and sponsors of products must hold the evidence for any claim of efficacy made about them. Adverse reactions to CAM products can be classified as intrinsic (innate to the product), or extrinsic (where the risk is not related to the product itself, but results from the failure of good manufacturing practice). Adverse reactions to CAM practices can be classified as risks of commission (which includes removal of medical therapy) and risks of omission (which includes failure to refer when appropriate). While few systematic studies of adverse events with CAM exist, and under-reporting is likely, most CAM products and practices do not appear to present a high risk; their safety needs to be put into the perspective of wider safety issues. A priority for research is to rigorously define the risks associated with both CAM products and practices so that their potential impact on public health can be assessed.
Adverse events and deterioration reported by participants in the PACE trial of therapies for chronic fatigue syndrome. [2022]Adverse events (AEs) are health related events, reported by participants in clinical trials. We describe AEs in the PACE trial of treatments for chronic fatigue syndrome (CFS) and baseline characteristics associated with them.
[No harm, no foul? Adverse events in pediatric complementary and alternative medicine use]. [2022]In the Netherlands, children are frequently using complementary and alternative medicine (CAM), but data on adverse events are scarce. A three-year registration amongst Dutch pediatricians found 32 cases of adverse events associated with pediatric CAM use. Twenty-two children experienced adverse events that were indirectly related to the CAM treatment, such as delaying or stopping a regular treatment or diagnosis or using an unnecessary (deficient) diet. These indirect effects involved many different therapies. Nine children experienced direct adverse events such as toxicity of an ingested substance or harm due to body manipulation. Direct effects occurred after using herbal medicine, high dose vitamins or supplements, and manual-based manipulation. The authors advise physicians to be aware of potential side-effects of CAM treatment in children and inform parents regarding its use. A list of ten recommendations for parents considering the use of CAM for their children is presented.
Telehealth-delivered group smoking cessation for rural and urban participants: feasibility and cessation rates. [2022]Large-group behavioral smoking cessation interventions are effective for helping people quit smoking, but have not been evaluated using videoconferencing technology for rural and remote participants who have no access to in-person cessation programs. The objectives of this study were to provide and evaluate an evidence-based group smoking cessation program for rural/remote smokers wishing to quit through a Telehealth videoconferencing link at their local Health Centre.
Proactive Referral to Behavioral Smoking Cessation Programs by Healthcare Staff: A Systematic Review. [2023]Behavioral smoking cessation programs are an effective tool for quitting smoking, yet remain underused by smokers. Proactive referral may be a promising strategy for healthcare staff to connect smokers to such programs.
Real-time video counselling for smoking cessation. [2023]Real-time video communication software such as Skype and FaceTime transmits live video and audio over the Internet, allowing counsellors to provide support to help people quit smoking. There are more than four billion Internet users worldwide, and Internet users can download free video communication software, rendering a video counselling approach both feasible and scalable for helping people to quit smoking.