mHealth Interventions for Smoking Cessation

(Project mFLi Trial)

Recruiting at 2 trial locations

Overseen By Sarah Jones

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: Pregnancy, Breastfeeding, others

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

Compensation: Varies

Number of Visits: 1

Duration: Up to 6 months

90 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the mHealth treatment for smoking cessation?

Research shows that smartphone apps for smoking cessation can be effective tools, especially when combined with other support methods. They are accessible and can reach many people, making them a promising option for helping individuals quit smoking. ^{1 2 3 4 5}

Is mHealth for smoking cessation safe for humans?

The research does not provide specific safety data for mHealth interventions for smoking cessation, but these apps are generally considered safe as they primarily offer support and motivation to quit smoking. ^{2 3 4 6 7}

How is the mHealth treatment for smoking cessation different from other treatments?

The mHealth treatment for smoking cessation is unique because it uses smartphone apps to provide counseling and motivation, making it easily accessible and convenient for users, especially young adults who frequently use smartphones. This approach leverages technology to offer personalized support and guidance, which is different from traditional methods like in-person counseling or medication. ^{7 8 9 10 11}

What is the purpose of this trial?

Despite the deleterious impact of smoking upon cancer treatment outcomes, smoking prevalence remains alarmingly high among cancer patients. Thus, reducing smoking by cancer patients is a public health priority, but treatments to date have demonstrated limited efficacy. Mobile health (mHealth) interventions have the potential to improve treatment efficacy while also greatly extending reach. The goal of this infrastructure proposal is to build a resource to facilitate the creation of mHealth tools that address the tobacco treatment needs of cancer patients. This resource, which will be available to researchers throughout Florida, would fill a critical gap in mHealth capacity.

Research Team

Damon Vidrine, DrPH

Principal Investigator

Moffitt Cancer Center

Vani Simmons, PhD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

This trial is for English-speaking cancer patients who have smoked at least 100 cigarettes in their lifetime, currently smoke, own a working smartphone, and are 18 or older. Pregnant or breastfeeding individuals, or those who don't confirm participation electronically within two weeks of being chosen, cannot join.

Inclusion Criteria

≥100 lifetime cigarettes

English-speaking

Report smoking ≥ 1 cigarette in past 30 days

Exclusion Criteria

Failure to electronically confirm participation within 14 days of randomization via electronic link sent to participant's smartphone

Currently pregnant or breastfeeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

At Baseline

1 visit (in-person)

Treatment

Participants receive either Quitline or Mobile-Delivered Smoking Cessation Intervention

Up to 6 months

Follow-up

Participants are monitored for usability, acceptability, and satisfaction of the mHealth intervention

Up to 6 months

Treatment Details

Interventions

• App-based Treatment (mHealth)
• Quitline Treatment (QT)

Trial Overview The study is testing two smoking cessation methods: an app-based treatment (mHealth) and Quitline Treatment (QT). It aims to build resources to help create mHealth tools tailored for the tobacco treatment needs of cancer patients in Florida.

Participant Groups

Group I: Demonstration Project 2 Experimental Treatment 2 Interventions

Pilot RCT of Quitline vs. Mobile-Delivered Smoking Cessation Intervention for Cancer Patients. The goal of this pilot feasibility study is two-fold: to evaluate the performance of the platform itself and to provide preliminary data for a future efficacy trial.

Group II: Demonstration Project 1 Active Control 1 Intervention

Screening and recruitment of cancer patients for connection to evidence-based smoking cessation treatment. The goal of the first demonstration project is to develop a feasible and effective method for screening cancer patients for smoking, determining treatment eligibility, and offering treatment.

Group III: Demonstration Project 3 Active Control 1 Intervention

Utilizing machine learning to process data obtained from demonstration projects 1 and 2. In Demonstration Project 3, we will utilize all data collected in Demonstration Projects 1 and 2 to conduct machine and deep learning methods.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Florida Biomedical Research Program - James & Esther King

Collaborator

Findings from Research

The Stop-Tabac app, designed for smoking cessation, is being tested in a large randomized trial with 5200 participants to assess its effectiveness over 6 months, providing personalized support and feedback to users.

This study aims to address the lack of evidence on the impact of health apps for smoking cessation, potentially improving access to support and compliance with nicotine therapy for smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Stop-Tabac smartphone application for smoking cessation: study protocol for a randomized controlled trial in the general population. Etter, JF., Khazaal, Y.[2021]

Mobile health (mHealth) apps for smoking cessation, both as standalone general apps (GSC-Apps) and in combination with face-to-face interventions (FFSC-Apps), show promise in improving smoking cessation outcomes, with some studies indicating significant benefits from their use.

Despite the potential of these apps to reach a wide audience due to their accessibility, further high-quality research is necessary to fully understand their effectiveness and optimize their features for better results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking Cessation Apps: A Systematic Review of Format, Outcomes, and Features. Barroso-Hurtado, M., Suárez-Castro, D., Martínez-Vispo, C., et al.[2021]

A study involving 181 participants found that most users rated the smoking cessation app QuitPal-m as very helpful, but daily usage declined over time, indicating a need for ongoing support to maintain engagement.

The effectiveness of the app was enhanced by supportive accountability from cessation counselors, particularly for smokers with low motivation to quit, highlighting the importance of addressing both personal barriers and technical issues to improve app usage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive Accountability and Mobile App Use in a Tobacco Control Intervention Targeting Low-Income Minority Mothers Who Smoke: Observational Study. Lepore, SJ., Collins, BN., Killam, HW., et al.[2023]

Mobile health applications are effective tools for helping individuals change their smoking habits, as they provide counseling and motivation for smoking cessation.

The review analyzed 12 studies that highlighted four different technological approaches, demonstrating the versatility and potential of mobile devices in supporting smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking Cessation: Services and Applications for Mobile Devices. Kefaliakos, A., Pliakos, I., Chardalias, K., et al.[2018]

A study of 252 smoking cessation apps for iPhone and 148 for Android revealed that popular apps generally have low adherence to U.S. Public Health Service guidelines, scoring an average of only 12.9 out of 42 on the Adherence Index.

None of the apps recommended calling a quitline, and only 4.1% suggested using approved medications, indicating a significant gap in evidence-based support for users trying to quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A content analysis of popular smartphone apps for smoking cessation. Abroms, LC., Lee Westmaas, J., Bontemps-Jones, J., et al.[2022]

In a pilot study involving 600 smokers, those receiving gain-framed text messages (focused on the benefits of quitting) made more quit attempts (98%) compared to those receiving loss-framed messages (93%).

While the overall smoking cessation rates at 30 weeks were similar between the gain-framed (17%) and loss-framed (15%) groups, the gain-framed messages appeared to encourage more proactive quitting behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quit4hlth: a preliminary investigation of tobacco treatment with gain-framed and loss-framed text messages for quitline callers. Rojewski, AM., Duncan, LR., Carroll, AJ., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

The Stop-Tabac smartphone application for smoking cessation: study protocol for a randomized controlled trial in the general population. [2021]

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

What Do People Want in a Smoking Cessation App? An Analysis of User Reviews and App Quality. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Smartphone health apps for tobacco Cessation: A systematic review. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Smoking Cessation Apps: A Systematic Review of Format, Outcomes, and Features. [2021]

5. Canada pubmed.ncbi.nlm.nih.gov

Supportive Accountability and Mobile App Use in a Tobacco Control Intervention Targeting Low-Income Minority Mothers Who Smoke: Observational Study. [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

Prioritizing the mHealth Design Space: A Mixed-Methods Analysis of Smokers' Perspectives. [2018]

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

Smoking Cessation: Services and Applications for Mobile Devices. [2018]

8. Canada pubmed.ncbi.nlm.nih.gov

Crush the Crave: Development and Formative Evaluation of a Smartphone App for Smoking Cessation. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

A content analysis of popular smartphone apps for smoking cessation. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

Effectiveness of eHealth Smoking Cessation Interventions: Systematic Review and Meta-Analysis. [2023]

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

Quit4hlth: a preliminary investigation of tobacco treatment with gain-framed and loss-framed text messages for quitline callers. [2022]