Videoconferencing Smoking Cessation Program for Smoking

Recruiting at 1 trial location

Overseen By Shanna Hunt

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of South Florida

Disqualifiers: Pregnant, Breastfeeding, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 19

Duration: 6 weeks

482 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if a smoking cessation program delivered via videoconferencing, called Positively Living, is more effective than a standard program in helping individuals with certain chronic health conditions quit smoking. Participants will receive nicotine patches and attend 12 online group sessions. The researchers will track how many people quit smoking over a year in the treatment group compared to the control group. This trial suits those who smoke cigarettes, have a chronic health condition, and are motivated to quit smoking. Participants need access to a private space with internet and a smartphone, tablet, or computer. As an unphased trial, this study offers an opportunity to contribute to innovative research that could enhance smoking cessation programs for people with chronic health conditions.

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 prior data suggests that this videoconferencing smoking cessation program is safe?

Research has shown that programs like the Positively Me trial, which help people quit smoking, are generally safe. These programs use techniques to support smoking cessation. The Positively Me program emphasizes group sessions and guidance, which participants usually handle well.

Participants may also choose to use nicotine replacement therapy (NRT) patches. The FDA has approved NRT, and it is commonly used to aid smoking cessation. Some individuals might experience mild side effects, such as skin irritation or trouble sleeping.

Overall, combining group support with NRT provides a safe method to help people quit smoking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Videoconferencing Smoking Cessation Program because it offers a novel approach to helping people quit smoking through virtual support rather than traditional in-person methods. This program includes two distinct interventions: Positively Living and Positively Me. Positively Me is particularly unique as it focuses on promoting smoking cessation by leveraging Social Cognitive Theory through a structured series of virtual sessions. Unlike standard nicotine replacement therapies or medications, these programs provide tailored behavioral support that can be accessed from anywhere, making it more flexible and accessible for participants. This innovative approach could potentially reach a broader audience and provide support to those who might not have access to conventional in-person programs.

What evidence suggests that this trial's treatments could be effective for smoking cessation?

Research shows that the "Positively Me" program, one of the treatment arms in this trial, can help people quit smoking. In past studies, participants in similar programs achieved better success rates than those in regular programs. For instance, one study found that 29.5% of participants in a similar program quit smoking, compared to only 14.9% in a standard program. The program is based on Social Cognitive Theory, which helps people change habits by focusing on thoughts and actions. These results suggest that "Positively Me" could effectively help people with certain health conditions stop smoking. Meanwhile, the "Positively Living" program, another arm in this trial, serves as a comparator and also uses Social Cognitive Theory to support healthy living. ^{1 6 7 8 9}

Who Is on the Research Team?

Stephanie L Marhefka, PhD

Principal Investigator

University of South Florida

Are You a Good Fit for This Trial?

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

living with certain health conditions

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Positively Living
• Positively Me

Trial Overview 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.

How Is the Trial Designed?

Group I: Positively Me Experimental Treatment 1 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 Living Placebo Group 1 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).

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A study involving 554 smokers showed that a Telehealth videoconferencing smoking cessation program for rural participants achieved continuous abstinence rates of 25.5%, comparable to 27.5% for urban participants, indicating its effectiveness.

The program maintained similar quit rates over a 12-month follow-up, demonstrating that remote access to behavioral smoking cessation interventions can be as effective as in-person programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth-delivered group smoking cessation for rural and urban participants: feasibility and cessation rates. Carlson, LE., Lounsberry, JJ., Maciejewski, O., et al.[2022]

A systematic review of two randomized trials involving 615 participants found no significant difference in smoking cessation rates between real-time video counselling and telephone counselling, indicating that video counselling may not be more effective for quitting smoking.

The overall evidence quality was rated very low due to methodological issues and inconsistencies, suggesting that more rigorous studies are needed to better understand the effectiveness of video counselling for smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time video counselling for smoking cessation. Tzelepis, F., Paul, CL., Williams, CM., et al.[2023]

A significant majority (85%) of people with Multiple Sclerosis (PwMS) use natural medicine and dietary supplements (NADS), with vitamin D being the most commonly used, followed by fatty acids and multivitamins.

About 75.8% of PwMS reported using NADS alongside their conventional MS treatments, highlighting a potential risk for drug interactions, especially among younger, newly diagnosed patients with higher education levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of natural medicine and dietary supplements concomitant with conventional medicine among people with Multiple Sclerosis. Bergien, SO., Petersen, CM., Lynning, M., et al.[2021]

A three-year study among Dutch pediatricians identified 32 cases of adverse events related to complementary and alternative medicine (CAM) use in children, highlighting the need for awareness of potential risks.

Most adverse events (22 cases) were indirectly related to CAM, such as delaying conventional treatments, while 9 cases involved direct harm from substances like herbal medicine or high-dose vitamins, emphasizing the importance of informing parents about the safety of CAM options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[No harm, no foul? Adverse events in pediatric complementary and alternative medicine use]. Rake, JP., Vos, BO., Vlieger, AM.[2022]

In a study involving 239 participants, the Quit Kit self-help package showed that 13.6% of users were able to quit smoking after 2 months, and this increased to 17.9% after 12 months, indicating its effectiveness as a smoking cessation tool.

The results suggest that mediated interventions, like the Quit Kit and the 'Calling It Quits' television segments, have potential in helping individuals quit smoking, highlighting the importance of accessible support resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediated smoking cessation programs in the Stanford Five-City Project. Sallis, JF., Flora, JA., Fortmann, SP., et al.[2019]

The use of complementary and alternative medicine (CAM) among children is increasing, particularly among parents seeking treatments for chronic illnesses, but there is limited data on the risks and adverse drug reactions (ADRs) associated with these therapies.

Many parents believe CAM therapies are 'natural' and therefore 'safe', highlighting the need for pediatricians to be better informed about CAM to effectively communicate with families and address misconceptions, ultimately minimizing risks associated with these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns and perceptions of complementary/alternative medicine among paediatricians and patients' mothers: a review of the literature. Cuzzolin, L., Zaffani, S., Murgia, V., et al.[2022]

The effectiveness of smoking cessation programs is strongly linked to the positive reinforcement smokers receive for abstaining from smoking, suggesting that encouragement plays a crucial role in their success.

The outlined program is designed to be efficient for physicians, requiring minimal time commitment while providing a self-sustaining support system for smokers who wish to quit, making it a rewarding experience for both parties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation strategies and evaluation. Kottke, TE., Solberg, LI., Brekke, ML., et al.[2019]

Many consumers mistakenly believe that complementary and alternative medicine (CAM) products are inherently safe, which raises concerns about potential interactions with pharmaceutical drugs, especially as their simultaneous use increases among Australians.

While adverse reactions to CAM products are generally low, there is a need for more systematic research to accurately define the risks associated with CAM, as current evidence suggests that most products do not pose a high risk but require further investigation to understand their impact on public health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The other side of the coin: safety of complementary and alternative medicine. Myers, SP., Cheras, PA.[2004]

In the PACE trial involving 641 participants with chronic fatigue syndrome, serious adverse events were rare, while non-serious adverse events were common, with no significant differences in their occurrence across different treatment groups.

Physical deterioration was most frequently reported after adaptive pacing therapy (APT), affecting 25% of participants, indicating that while treatments did not significantly differ in adverse events, APT may be associated with a higher risk of worsening physical function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events and deterioration reported by participants in the PACE trial of therapies for chronic fatigue syndrome. Dougall, D., Johnson, A., Goldsmith, K., et al.[2022]

Smoking cessation is the most effective way to stop the progression of chronic obstructive pulmonary disease (COPD), and effective methods include counseling, nicotine replacement therapies, and bupropion, which have strong evidence supporting their efficacy.

An individualized approach to smoking cessation is crucial, taking into account personal reasons for smoking and available resources, while healthcare professionals, especially respiratory therapists, play a key role in encouraging patients to quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation. Marlow, SP., Stoller, JK.[2017]

Telephonic tobacco cessation coaching significantly improved quit rates among participants (31%) compared to matched controls (23%), demonstrating its effectiveness in real-world clinical settings.

Participants in the coaching program also filled prescriptions for tobacco cessation medications at a much higher rate (47%) than those who received no treatment (6%), indicating that the coaching not only helped with quitting but also encouraged the use of cessation aids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone-Based Coaching. Boccio, M., Sanna, RS., Adams, SR., et al.[2022]

Proactive referral by healthcare staff significantly increases enrollment rates in behavioral smoking cessation programs, particularly benefiting low-income smokers, as shown in a systematic review of 34 studies.

E-referral systems are more effective and acceptable for implementing proactive referrals compared to traditional fax systems, suggesting that they could enhance access to smoking cessation resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proactive Referral to Behavioral Smoking Cessation Programs by Healthcare Staff: A Systematic Review. van Westen-Lagerweij, NA., Hipple Walters, BJ., Potyka, F., et al.[2023]

The Happy Ending (HE) smoking cessation program, a fully automated digital intervention, significantly increased long-term abstinence rates among participants, achieving 20% abstinence compared to 7% in the control group over 12 months.

Participants in the HE program showed improved coping planning and self-efficacy before quitting, which partially mediated the treatment effect for short-term abstinence, highlighting the program's effectiveness in enhancing smokers' readiness to quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A digital smoking cessation program delivered through internet and cell phone without nicotine replacement (happy ending): randomized controlled trial. Brendryen, H., Drozd, F., Kraft, P.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04449458

The Positively Quit Trial for Smoking Cessation The main goal of the present study is to determine if a smoking cessation program designed for people living with certain chronic conditions and delivered ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714421002111

A tailored telehealth group tobacco cessation treatment ... Biochemically confirmed 7-day point prevalence smoking abstinence at day 360 is the primary outcome. Cost per quit, sustained abstinence at various timepoints, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9203899/

A randomized trial of a web-based tobacco treatment and ... For the endpoint of 30-day point-prevalence abstinence at 6-months (Table 1), in ITT analyses 11.4% of the PSFW+ participants were abstinent compared to 6.4 % ...

4. evidence.nejm.org evidence.nejm.org/doi/full/10.1056/EVIDoa2400090

Efficacy of Smoking Cessation Interventions among People ... Among participants randomized to receive PSF therapy, 29.5% were abstinent from smoking, compared with 14.9% in the standard of care group (odds ...

5. nature.com nature.com/articles/s41562-025-02295-2

Efficacy of digital interventions for smoking cessation by ... SMS interventions demonstrated the highest efficacy (RR 1.63, 95% CI 1.38–1.92), indicating a 63% increased smoking cessation success compared ...

6. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-05551

The Positively Quit Trial for Smoking Cessation - NCI The main goal of the present study is to determine if a smoking cessation program designed for people living with certain chronic conditions and delivered ...

7. grantome.com grantome.com/grant/NIH/R01-CA243800-01

The Positively Quit Trial: Addressing disproportionate ... PLH who smoke reduce their life expectancy by 12.3 years on average. The lack of access to proven, effective, and HIV-tailored tobacco cessation services ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9732762/

Outcomes of a Comprehensive Mobile Smoking Cessation ... This study aimed to compare engagement, retention, attitudes toward quitting smoking, smoking behavior, and participant feedback between Pivot and QuitGuide.

9. truthinitiative.org truthinitiative.org/research-resources/quitting-smoking-vaping/quitting-tobacco-facts-and-stats

Quitting Tobacco: Facts and Stats In 2020, 8.5% of adult current smokers successfully quit smoking in the past year, up from 7.5% in 2018.