Videoconferencing Smoking Cessation Program for Smoking

Recruiting at1 trial location

Overseen by Stephanie 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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{1 3 11 12 13}

Research Team

Stephanie L Marhefka, PhD

Principal Investigator

University of South Florida

Eligibility 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

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)

Treatment Details

Interventions

• Positively Living (Behavioural Intervention)
• Positively Me (Behavioural Intervention)

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.

Participant Groups

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+

Dr. Barbara White

University of South Florida

Chief Medical Officer since 2021

MD, University of Pennsylvania School of Medicine

Dr. Sylvia W. Thomas

University of South Florida

Chief Executive Officer since 2023

Ph.D. in Electrical Engineering, University of South Florida

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Telephone-Based Coaching. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Smoking cessation strategies and evaluation. [2019]

3. Canada pubmed.ncbi.nlm.nih.gov

A digital smoking cessation program delivered through internet and cell phone without nicotine replacement (happy ending): randomized controlled trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Smoking cessation. [2017]

5. England pubmed.ncbi.nlm.nih.gov

Mediated smoking cessation programs in the Stanford Five-City Project. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

Patterns and perceptions of complementary/alternative medicine among paediatricians and patients' mothers: a review of the literature. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Use of natural medicine and dietary supplements concomitant with conventional medicine among people with Multiple Sclerosis. [2021]

8. Australia pubmed.ncbi.nlm.nih.gov

The other side of the coin: safety of complementary and alternative medicine. [2004]

9. England pubmed.ncbi.nlm.nih.gov

Adverse events and deterioration reported by participants in the PACE trial of therapies for chronic fatigue syndrome. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

[No harm, no foul? Adverse events in pediatric complementary and alternative medicine use]. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Telehealth-delivered group smoking cessation for rural and urban participants: feasibility and cessation rates. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Proactive Referral to Behavioral Smoking Cessation Programs by Healthcare Staff: A Systematic Review. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Real-time video counselling for smoking cessation. [2023]