Telehealth Smoking Cessation for Quitting Smoking

(E-STOP Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Medical University of South Carolina

Must not be taking: Cessation medications

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to evaluate an electronic visit (e-visit) for smoking cessation. Participants will be randomly assigned to receive either the smoking cessation e-visit or not. The e-visit will look similar to an online questionnaire asking about smoking history, motivation to quit, and preferences for medications for quitting smoking. Participants may receive a prescription for a smoking cessation medication as an outcome of the e-visit, if randomized to the e-visit group, but there is no requirement to take any medication. This study consists of questionnaires and breath samples provided at 4 separate time points throughout the study. Participation in this study will take about 24 weeks.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used an FDA-approved smoking cessation medication in the last 7 days before joining.

What data supports the effectiveness of the treatment Telehealth Smoking Cessation for Quitting Smoking?

Research shows that eHealth interventions, like online and telehealth programs, can effectively help people quit smoking by providing personalized support and resources. Internet-based programs have been found to be a promising alternative to traditional face-to-face methods, offering convenience and accessibility. ^{1 2 3 4 5}

Is telehealth smoking cessation generally safe for humans?

The studies reviewed did not report any specific safety concerns related to telehealth smoking cessation programs, suggesting they are generally safe for human use. ^{2 6 7 8 9}

How is the Telehealth Smoking Cessation treatment different from other smoking cessation treatments?

The Telehealth Smoking Cessation treatment is unique because it uses online and telehealth platforms to provide support, making it accessible for people who cannot attend in-person programs. This approach is particularly beneficial for individuals in rural or remote areas, offering a convenient and flexible alternative to traditional face-to-face or telephone-based support. ^{2 8 10 11 12}

Research Team

Eligibility Criteria

This trial is for adults who smoke at least 5 cigarettes a day, are fluent in English, have daily email access, and own a smartphone. They must be enrolled or willing to enroll in MyChart with a valid address. It's not for those who've used FDA-approved quitting meds recently.

Inclusion Criteria

I check my email daily with a valid email address.

Have a valid mailing address

English fluency

Exclusion Criteria

I have used a quit-smoking medication approved by the FDA in the past week.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to receive either the smoking cessation e-visit or not, with e-visits including questionnaires and potential prescriptions for smoking cessation medication.

24 weeks

4 visits (virtual)

Follow-up

Participants are monitored for smoking cessation outcomes, including medication adoption, treatment utilization, and smoking reduction.

4 weeks

Treatment Details

Interventions

• Smoking cessation e-visit (Behavioral Intervention)
• Treatment As Usual (Behavioral Intervention)

Trial Overview The study tests an e-visit system designed to help people quit smoking against the usual treatment methods. Participants will either receive this innovative online support tool or continue with standard care without the e-visit intervention.

Participant Groups

Group I: Smoking cessation electronic visit (e-visit) Experimental Treatment 1 Intervention

This group will be sent 1) an invitation to complete an electronic visit (e-visit) focused on cigarette smoking and 2) an invitation to complete a follow-up e-visit one-month after the initial e-visit.

Group II: Treatment as usual (TAU) Active Control 1 Intervention

This group will be provided information about the state quitline and about the importance of quitting smoking and it will be recommended that they contact their PCP to schedule a medical visit to discuss quitting smoking.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Dr. Erik Summers

Medical University of South Carolina

Chief Medical Officer

MD from University of Alabama at Birmingham

Dr. Patrick J. Cawley

Medical University of South Carolina

Chief Executive Officer

MD, MBA

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

The Decide2Quit program, a tailored web-based and e-message smoking cessation intervention, is being tested on 1,488 hospitalized smokers to evaluate its effectiveness in promoting tobacco cessation after discharge.

The primary outcome of the study is self-reported 30-day tobacco abstinence at 6 months, with secondary outcomes including various quit rates and cost-effectiveness assessments, highlighting the program's potential for broad implementation with minimal burden on hospital staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based smoking cessation intervention that transitions from inpatient to outpatient: study protocol for a randomized controlled trial. Harrington, KF., McDougal, JA., Pisu, M., et al.[2021]

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 study evaluated an asynchronous smoking cessation e-visit for adult smokers in primary care, involving 51 participants, and found it to be acceptable and feasible, with high satisfaction rates among users.

The e-visit showed promising efficacy in improving smoking cessation outcomes compared to standard treatment, with participants having higher odds of quitting at both 1 month (ORs: 2.10-5.39) and 3 months (ORs: 1.31-4.67) post-enrollment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Proactive Smoking Cessation Electronic Visit to Extend the Reach of Evidence-Based Cessation Treatment via Primary Care. Dahne, J., Player, M., Carpenter, MJ., et al.[2022]

The study evaluated the effects of five different smoking cessation interventions on 1,034 smokers, revealing that both the National Cancer Institute's website and nicotine replacement therapy (NRT) significantly increased smoking abstinence rates.

However, the effectiveness of the NCI website was reduced when combined with motivational email messages, indicating that certain interventions may interact negatively with each other.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five population-based interventions for smoking cessation: a MOST trial. Fraser, D., Kobinsky, K., Smith, SS., et al.[2022]

A quit-line for smoking cessation in Iran successfully helped 122 out of 148 participants (82.4%) quit smoking, demonstrating the efficacy of telephone counseling for smokers who cannot attend in-person programs.

The program showed a sustained abstinence rate of 59% after 1 month, which decreased over time, indicating that while initial success is high, ongoing support is crucial for long-term cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of telephone quit-line for smokers in iran: 12 months follow up results. Heydari, G., Jianfar, G., Alvanpour, A., et al.[2021]

Approximately 1.6% to 2.5% of adult smokers expressed interest and enrolled in Project Quit, an online smoking cessation program, indicating a notable interest in digital support for quitting smoking.

Proactive recruitment methods, such as invitation letters sent to likely smokers, were significantly more effective than other strategies, leading to 69% of website visitors and 68% of enrollees, highlighting the importance of targeted outreach in engaging smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interest in an online smoking cessation program and effective recruitment strategies: results from Project Quit. McClure, JB., Greene, SM., Wiese, C., et al.[2022]

In a study of 837 daily smokers, those receiving telephone care had a significantly higher 6-month smoking cessation rate (13.0%) compared to those receiving standard care (4.1%), indicating that telephone counseling is a more effective intervention.

Participants in the telephone care group were much more likely to engage in counseling programs (97.1% vs 24.0%) and use smoking cessation medications (89.6% vs 52.3%), suggesting that telephone care enhances both behavioral and pharmacological support for quitting smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of telephone care over primary care for smoking cessation: a randomized trial. An, LC., Zhu, SH., Nelson, DB., et al.[2022]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Which eHealth interventions are most effective for smoking cessation? A systematic review. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a Fully Automated Internet-Based Smoking Cessation Program: A Randomized Controlled Trial (STAMP). [2020]

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

Comparative Effectiveness of an Internet-Based Smoking Cessation Intervention Versus Clinic-Based Specialty Care for Veterans. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Web-based smoking cessation intervention that transitions from inpatient to outpatient: study protocol for a randomized controlled trial. [2021]

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

Telephone-Based Coaching. [2022]

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

Evaluation of a Proactive Smoking Cessation Electronic Visit to Extend the Reach of Evidence-Based Cessation Treatment via Primary Care. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Five population-based interventions for smoking cessation: a MOST trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

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

9. Canada pubmed.ncbi.nlm.nih.gov

Impact of Baseline Assessment Modality on Enrollment and Retention in a Facebook Smoking Cessation Study. [2018]

10. Iran pubmed.ncbi.nlm.nih.gov

Efficacy of telephone quit-line for smokers in iran: 12 months follow up results. [2021]

11. Canada pubmed.ncbi.nlm.nih.gov

Interest in an online smoking cessation program and effective recruitment strategies: results from Project Quit. [2022]

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

Benefits of telephone care over primary care for smoking cessation: a randomized trial. [2022]