Smartphone App for Smoking Cessation

Overseen By Jennifer Minnix

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Medical condition, Psychiatric disorder, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two smartphone apps to evaluate their effectiveness in helping people quit smoking. KickAsh focuses on teaching relaxation skills, while Breathe2Relax aims to improve mood and increase enjoyable activities. The trial seeks current smokers who have smoked for at least a year, have elevated depressive symptoms now or in the past, and are ready to quit within the next month. Participants must have an Apple device and regularly use apps. As an unphased trial, this study offers a unique opportunity to explore innovative tools to support the journey to quit smoking.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if any medication could compromise your safety or treatment, the Principal Investigator may decide it's necessary.

What prior data suggests that these smartphone mobile applications are safe for smoking cessation?

Research shows that the KickAsh smartphone app is popular with users and may help smokers quit. Previous studies found that users felt better and were more likely to stop smoking. No serious side effects emerged, indicating the app is safe to use.

For the Breathe2Relax app, studies indicate it's a useful tool for managing stress. It provides exercises to help users relax and has been used without any major problems. Overall, both apps appear safe and well-liked by users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these smartphone apps for smoking cessation because they offer unique, personalized approaches to help individuals quit smoking. Unlike traditional methods like nicotine replacement therapy or prescription medications, these apps focus on behavioral changes. The KickAsh app aims to teach relaxation skills over an eight-week period, helping users manage cravings and stress without relying on nicotine. On the other hand, the Breathe2Relax app is designed to boost mood and encourage enjoyable activities, providing a positive reinforcement strategy to aid in quitting smoking. These digital tools provide an innovative, accessible, and potentially empowering way for people to combat smoking addiction.

What evidence suggests that these smartphone mobile applications are effective for smoking cessation?

Research has shown that smartphone apps can help people quit smoking. In this trial, participants will use one of two apps. Some participants will use the KickAsh app, designed to help users relax and potentially lower the urge to smoke. Studies have found that people using such apps are more likely to quit smoking over time. Meanwhile, other participants will use the Breathe2Relax app, which helps improve mood and encourages enjoyable activities, potentially reducing smoking. Although more research is needed, these apps appear promising as tools to support smoking cessation. ^{1 3 4 6 7}

Who Is on the Research Team?

Jennifer A. Minnix

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for English-speaking MD Anderson patients aged 18-65 who smoke daily, own an iOS device with regular app usage, and are willing to set a quit date within 30 days. They must have smoked for at least a year and either currently have or previously had depressive symptoms. People can't join if they're in another smoking cessation program or have health issues that make the study unsafe for them.

Inclusion Criteria

Not engaged in smoking cessation treatment other than the MDACC Tobacco Treatment Program

I am a patient at MD Anderson, aged between 18 and 65.

I am willing to commit to quitting smoking within the next 30 days.

Exclusion Criteria

I don't have any health or mental conditions that could make the treatment unsafe for me.

Subject considered by the investigator an unsuitable candidate for receipt of a smoking cessation treatment or unstable to be followed up throughout the entire duration of the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the KickAsh or Breathe2Relax smartphone mobile application designed to help with smoking cessation over 8 weeks

8 weeks

Regular phone calls and interviews

Follow-up

Participants are monitored for changes in activity level, mood, and smoking abstinence

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Smartphone Mobile Application

Trial Overview

The study is testing how effective smartphone apps are in helping smokers quit. Participants will use these apps as part of their smoking cessation treatment to see if it enhances their ability to stop smoking.

How Is the Trial Designed?

Group I: Group II (Breathe2Relax smartphone mobile application) Experimental Treatment 2 Interventions

Participants receive Breathe2Relax smartphone mobile application designed to help improve mood and increase level of enjoyable activities over 8 weeks.

Group II: Group I (KickAsh smartphone mobile application) Experimental Treatment 2 Interventions

Participants receive KickAsh smartphone mobile application designed to help the learning of relaxation skills over 8 weeks.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Smartphone applications for smoking cessation have been shown to increase quit rates among smokers, particularly when users engage with features like audiovisual content, quit plans, and progress tracking.

While these apps can help reduce relapse rates, the effectiveness varies based on how well users adhere to the app's features, indicating that user engagement is crucial for success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Mobile Apps for Smoking Cessation: A Review. Regmi, K., Kassim, N., Ahmad, N., et al.[2020]

A smartphone app designed for smoking cessation effectively assessed real-time risk for smoking lapses and provided tailored messages, leading to greater reductions in smoking urges, stress, and cigarette availability among participants (N=59) over a 3-week period.

Messages specifically tailored to individual triggers, such as smoking urges and stress, were more effective in reducing those triggers compared to generic messages, suggesting that personalized interventions can enhance smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An ecological momentary intervention for smoking cessation: The associations of just-in-time, tailored messages with lapse risk factors. Hébert, ET., Stevens, EM., Frank, SG., et al.[2022]

Out of 651 smartphone apps analyzed for smoking cessation, only 15 were focused specifically on this goal, with a majority categorized as calendars or information tools.

The evaluated apps showed a low adherence to established smoking cessation guidelines, with a mean score of only 12.8, indicating a need for improvement and the development of future apps based on evidence-based practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of smartphone apps for smoking cessation available in Portuguese. Formagini, TD., Ervilha, RR., Machado, NM., et al.[2018]

The STaR smartphone application for smoking cessation received an average quality score of 3.31 and a compliance score of 2.50 on a 5-point scale, indicating it meets some but not all quality standards for smoking cessation support.

The app effectively incorporates key components of smoking cessation guidelines, including the 5A and 5R approaches, suggesting that enhancing its content could further improve its effectiveness in helping users quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of content, quality and compliance of the STaR mobile application for smoking cessation. Regmi, K., Kassim, N., Ahmad, NH., et al.[2020]

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]

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 955 Dutch smokers and ex-smokers found that the intention to use a smoking cessation app is strongly influenced by the number of previous quit attempts and the level of nicotine dependence, rather than demographic factors like age or education.

Personal innovativeness also plays a significant role in users' attitudes toward cessation apps, indicating that app design should focus on addressing the specific needs and experiences of potential users to enhance engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of Users for a Smoking Cessation Mobile App: Quantitative Study. Chevalking, SKL., Ben Allouch, S., Brusse-Keizer, M., et al.[2019]

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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03519451

Use of a Smartphone Mobile Application (App) to Enhance ...

Study Overview. Brief Summary. This trial studies how well smartphone mobile applications work in enhancing smoking cessation treatment in current smokers.

2.

withpower.com

withpower.com/trial/phase-3-2019-0b915

Mobile Apps for Smoking Cessation · Info for Participants

Trial Overview The study tests two smartphone apps' effectiveness in aiding smoking cessation among participants already enrolled in a Tobacco Treatment Program ...

3.

trial.medpath.com

trial.medpath.com/clinical-trial/08df3471ee514c79/acceptability-mobile-apps-smoking-cessation

Acceptability of Mobile Applications (Apps) to Enhance ...

Participants will receive either the Free4Good mobile app for positive psychology skills training or a breathing relaxation mobile app control (Breathe2Relax).

4.

clinicaltrial.be

clinicaltrial.be/en/details/7341?active_not_recruiting=1&completed=0&enrolling_by_invitation=1&only_active=0&only_eligible=0&only_recruiting=0&per_page=20

Use of a Smartphone Mobile Application (App) to Enhance ...

a relaxation app, Breathe2Relax in a small randomized controlled trial of smokers with elevated depressive symptoms. OUTLINE: Participants are ...

5.

play.google.com

play.google.com/store/apps/details?id=mil.dha.breathe2relax&hl=en_US

Breathe2Relax - Apps on Google Play

Breathe2Relax is a portable stress management tool which provides detailed information on the effects of stress on the body and instructions and practice ...

6.

mobile.health.mil

mobile.health.mil/Apps/PWA-Apps/Breathe-2-Relax

Breathe2Relax - mobile apps - Health.mil

Breathe2Relax is a portable stress management tool which provides detailed information on the effects of stress on the body and instructions and practice ...

7.

participaid.co

participaid.co/studies/9avO8b

App to Enhance Smoking Cessation Treatment - ParticipAid

Official Study Title. Use of a Smartphone Mobile Application (App) to Enhance Smoking Cessation Treatment - A Pilot Study ; Clinical Trial ID. NCT03519451 ...