Smartphone Application Smoking Cessation Study

Tobacco Use Clinical Trial

Official title:

Assessment of Smoking Cessation in a Publicly Available Cessation Smartphone Application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04623736
• Other study ID #: 3643
• Status: Completed
• Phase: N/A
• Start date: October 19, 2020
• Est. completion date: June 10, 2021

Study information

• Verified date: November 2021
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine if using the smartphone application quitSTART can help people quit smoking and to understand how use of specific smartphone application features when trying to quit smoking is associated with success.

Description:

Cigarette smoking is the leading cause of preventable death in the U.S. and causes multiple cancers. Approximately 34 million U.S. adults currently smoke cigarettes, but over half of all smokers attempt to quit smoking each year. However, only about 6% quit successfully, in part, because many smokers make unassisted quit attempts, due to the lack of accessibility of cessation programs. Mobile health (mHealth) smoking cessation programs delivered through smartphone applications ('apps') can potentially reach a large number of smokers in the U.S., as 81% of U.S. adult smokers own a smartphone. The National Cancer Institute hosts Smokefree.gov, a suite of free, publicly available smoking cessation resources. In addition to web based and text-messaging resources, Smokefree.gov launched the quitSTART smartphone app in 2013, which is a publicly available smoking cessation app.

Participants in this study will be asked to complete a pre-cessation assessment, then download, install, and try to quit smoking using the smoking cessation smartphone application, quitSTART. Participants will be asked to use quitSTART for 4 weeks. Participants will also be asked to complete online surveys 2 and 4 weeks after the start of the study. To understand how people are using quitSTART, the investigators will collect quitSTART usage data from all participants (for example, how often someone opens quitSTART during the study period and what specific features someone uses).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: June 10, 2021
• Est. primary completion date: May 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cigarette smoker

• Smoked at least 100 cigarettes

• Able to read and speak English

• Owns a smartphone

• 18 years of age or older

• USA resident

Exclusion Criteria:

• Not a cigarette smoker

• has not smoked at least 100 cigarettes

• Not able to read and speak English

• Does not own a smartphone

• Under 18 years of age

• Not a US resident

• Currently pregnant

Related Conditions & MeSH terms

• Tobacco Use

Intervention

Behavioral:
• quitSTART
All participants will have access to the Smokefree.gov Initiative smoking cessation smartphone application, quitSTART. This app is available, at no cost, to anyone who owns a smartphone and is interested in quitting smoking. All smokers who download quitSTART are asked to provide basic information about themselves (e.g., age, sex, reason to quit smoking, triggers to smoke, when users typically smoke, how users plan to celebrate success, smoking frequency, age when started smoking regularly, ethnicity, race, cigarettes smoked per day), and set a quit date. Information about cessation and challenges to help support quitting are available, as well as games and tracking features. While using the app, users can proactively report cigarette cravings, if they slipped, if they are feeling "down" or feeling "great". If a user reports a craving, they have the option to mark the timing or location of the craving and request a reminder to resist future cravings at the same time or location.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
University of Virginia	ICF International, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported 7-day smoking abstinence - 2 weeks	"Have you smoked a cigarette (even a puff) in the past 7 days?" self-reported by the participant	2 weeks
Primary	Self-reported 7-day smoking abstinence - 4 weeks	"Have you smoked a cigarette (even a puff) in the past 7 days?" self-reported by the participant	4 weeks
Secondary	Self-reported continuous smoking abstinence - 2 weeks	"In the last two weeks, have you smoked at all?" self-reported by the participant	2 weeks
Secondary	Self-reported continuous smoking abstinence - 4 weeks	"In the last four weeks, have you smoked at all?" self-reported by the participant	4 weeks