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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new mobile health (mHealth) tools to help cancer patients quit smoking. By testing an app-based treatment against a traditional quitline treatment, researchers aim to determine which method more effectively aids smoking cessation. The study will also use data to enhance future tools through advanced technology like machine learning, which learns from data. Candidates may be suitable if they are cancer patients who have smoked at least 100 cigarettes in their lifetime, currently smoke, have access to a smartphone, and seek support to quit smoking. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve future smoking cessation tools for cancer patients.

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 prior data suggests that these mHealth interventions are safe for cancer patients?

Research has shown that treatments using apps to help people quit smoking are generally easy to use and well-liked. One study found that a mobile app for quitting smoking was popular and user-friendly, meaning people found it simple to use and were satisfied with it. Studies have reported no major safety issues.

For the Quitline treatment, research also indicates it is well-received. Many people participate in the program and receive additional support, such as medications to stop smoking. Quitlines have consistently supported those who want to quit smoking, with no significant safety problems reported.

Both app-based and Quitline treatments are safe ways to help people quit smoking, with users generally responding positively to these methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to help cancer patients quit smoking. Unlike traditional methods, such as nicotine replacement therapy or prescription medications, this trial is testing an app-based treatment that delivers smoking cessation support directly to a person's smartphone. The app aims to make help more accessible and convenient, potentially reaching patients who might not seek traditional face-to-face options. Additionally, the study uses machine learning to analyze data, which could lead to more personalized and effective treatment strategies in the future. This approach could revolutionize how smoking cessation support is delivered, making it more adaptable to individual needs.

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

Research has shown that mobile health (mHealth) apps can significantly aid people in quitting smoking. Studies have found that smartphone apps can increase the chances of quitting. In some cases, these technology-based methods have raised the number of people who remain smoke-free by up to 88% after six months. In this trial, some participants will receive the App-based Treatment (mHealth). Similarly, Quitline services, which provide phone support, have also proven effective. One study found that 23.3% of people who used Quitline remained smoke-free after 12 months. Other participants in this trial will receive the Quitline Treatment (QT). Both mHealth apps and Quitline services are promising tools for helping cancer patients quit smoking. ^{6 7 8 9 10}

Who Is on the Research Team?

Damon Vidrine, DrPH

Principal Investigator

Moffitt Cancer Center

Vani Simmons, PhD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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 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]

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]

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