Smartphone Application Smoking Cessation Study

Assessment of Smoking Cessation in a Publicly Available Cessation Smartphone Application

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use
• Intervention / Treatment: Behavioral: quitSTART

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22904
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: quitSTART

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported continuous smoking abstinence - 2 weeks	"In the last two weeks, have you smoked at all?" self-reported by the participant	2 weeks
Self-reported continuous smoking abstinence - 4 weeks	"In the last four weeks, have you smoked at all?" self-reported by the participant	4 weeks

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: National Cancer Institute (NCI); ICF International
• Investigators: Principal Investigator: Kara P Wiseman, University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2020
• Primary Completion (Actual): May 12, 2021
• Study Completion (Actual): June 10, 2021

Study Registration Dates

• First Submitted: October 30, 2020
• First Submitted That Met QC Criteria: November 9, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Actual): November 10, 2021
• Last Update Submitted That Met QC Criteria: November 9, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Smoking cessation; mHealth; Tobacco use; Smartphone applications
• Other Study ID Numbers: 3643

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: If requested, a de-identified dataset will be available to other researchers after the study is completed.
• IPD Sharing Time Frame: After study completion
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No