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OpenTrials
Completed

NCT Number: NCT04623736

Smartphone Application Smoking Cessation Study

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.

Completed

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Key information

Conditions

Tobacco Use Behavior Health Behavior Smoking Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22904, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

quitSTART

Behavioral

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.

Primary outcomes

  1. Self-reported 7-day smoking abstinence - 2 weeks

    Time frame: 2 weeks

    "Have you smoked a cigarette (even a puff) in the past 7 days?" self-reported by the participant

  2. Self-reported 7-day smoking abstinence - 4 weeks

    Time frame: 4 weeks

    "Have you smoked a cigarette (even a puff) in the past 7 days?" self-reported by the participant

Secondary outcomes

  1. Self-reported continuous smoking abstinence - 2 weeks

    Time frame: 2 weeks

    "In the last two weeks, have you smoked at all?" self-reported by the participant

  2. Self-reported continuous smoking abstinence - 4 weeks

    Time frame: 4 weeks

    "In the last four weeks, have you smoked at all?" self-reported by the participant

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • ICF International
  • National Cancer Institute (NCI)

Registry information

Official study title

Assessment of Smoking Cessation in a Publicly Available Cessation Smartphone Application

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 10, 2020
Registry last updated
Nov 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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