90 Participants Needed

mHealth Interventions for Smoking Cessation

(Project mFLi Trial)

Recruiting at 2 trial locations
SJ
Overseen BySarah Jones
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.23467

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.7891011

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

DV

Damon Vidrine, DrPH

Principal Investigator

Moffitt Cancer Center

VS

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
See 1 more

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
3Treatment groups
Experimental Treatment
Active Control
Group I: Demonstration Project 2Experimental Treatment2 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 1Active Control1 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 3Active Control1 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.

Find a Clinic Near You

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.
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.
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.
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]

References

The Stop-Tabac smartphone application for smoking cessation: study protocol for a randomized controlled trial in the general population. [2021]
What Do People Want in a Smoking Cessation App? An Analysis of User Reviews and App Quality. [2022]
Smartphone health apps for tobacco Cessation: A systematic review. [2022]
Smoking Cessation Apps: A Systematic Review of Format, Outcomes, and Features. [2021]
Supportive Accountability and Mobile App Use in a Tobacco Control Intervention Targeting Low-Income Minority Mothers Who Smoke: Observational Study. [2023]
Prioritizing the mHealth Design Space: A Mixed-Methods Analysis of Smokers' Perspectives. [2018]
Smoking Cessation: Services and Applications for Mobile Devices. [2018]
Crush the Crave: Development and Formative Evaluation of a Smartphone App for Smoking Cessation. [2019]
A content analysis of popular smartphone apps for smoking cessation. [2022]
Effectiveness of eHealth Smoking Cessation Interventions: Systematic Review and Meta-Analysis. [2023]
Quit4hlth: a preliminary investigation of tobacco treatment with gain-framed and loss-framed text messages for quitline callers. [2022]
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