A Novel Smartphone Application for Helping Teens Stop Vaping, QuitQuest Vaping R01

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-17
SponsorFred Hutchinson Cancer Center

About this trial

This clinical trial compares a novel smartphone application (app) called QuitQuest to the National Cancer Institute's (NCI's) SmokefreeTeenQuitVaping (SFTQV) app in helping teens stop vaping. Despite recent declines, data shows that 8.5% of middle school (grades 6-8) and 18.1% of high school (grades 9-12) students in the United States (US) used electronic nicotine delivery systems (ENDS; variously known as vaping, electronic \[e\]-cigarettes, e-cigs, mods, and tank systems that contain nicotine). Use of any tobacco product during adolescence increases risk for lifelong nicotine addiction. ENDS use, in particular, leads to severe asthma attacks, e-cigarette or vaping product use-associated lung injury (EVALI), exposure to multiple lung irritants, including volatile organic compounds, and lasting harm to adolescent brain development. Despite evidence of potential long-term harms from ENDS, to date there have been limited evidence-based therapeutic options for ENDS cessation for adolescents and young adults. Traditional methods for delivering adolescent ENDS cessation interventions (e.g., quitlines and clinics) have limited reach. QuitQuest utilizes Acceptance and Commitment Therapy (ACT), a psychological intervention that uses acceptance and mindfulness strategies, together with commitment and behavior change strategies, to increase psychological flexibility, reduce distress, and promote behavior change through mechanisms that include cultivating acceptance of internal experience and aligning behavior with personal values. The SFTQV program is based on the US Clinical Practice Guidelines, offering practical advice and support via an app delivery format. The QuitQuest app may work better than the SFTQV app in increasing vape quit rates among teens.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 13 to 17

Used ENDS at least weekly in the past 30 days

Wants to quit ENDS within the next 30 days

If concurrently using any other nicotine or tobacco products, wants to quit using them within the next 30 days

Disqualifiers

Exclusion criteria are the reverse of the inclusion criteria

Trial design

Design model

Parallel

Treatments tested in this trial

  • Smartphone Application-based Intervention

    Behavioral

    Use QuitQuest app

  • Smartphone Application-based Intervention

    Behavioral

    Use SFTQV app

  • Survey Administration

    Other intervention

    Ancillary studies

  • Interview

    Other intervention

    Ancillary studies

Treatment groups

1,072 Participants
are divided into 2 treatment groups
Group A: Arm I (QuitQuest app)Experimental treatment 3 interventions
Group B: Arm II (SFTQV app)Active comparator 3 interventions

Trial outcomes

Primary outcomes

1

Self-reported 30-day point prevalence abstinence (PPA) from electronic nicotine delivery systems (ENDS) use

Biochemical verification will be used to validate self-reported abstinence among participants who opt in at baseline and complete testing. In the primary intent-to-treat analysis, participants with missing 6-month self-reported outcome data will be classified as vaping. The primary missing=vaping outcome is based on self-reported 30-day ENDS use status, not on completion of biochemical verification. Participants who self-report abstinence but do not complete biochemical testing will not be automatically classified as vaping solely because biochemical verification is missing. The primary logistic regression model will adjust for the stratification factors used in randomization to appropriately account for study design, thereby improving the estimation of standard errors and increasing the validity of significance tests for the main treatment effect.

Time frame
At 6 months post-randomization

Secondary outcomes

1

Self-reported 30-day PPA from ENDS use

Will investigate repeated 30-day PPA across 3, 6, and 12 months using mixed effects modeling.

Time frame
At 3 and 12 months post-randomization
2

Self-reported 24-hour PPA from ENDS use

Will investigate repeated 30-day PPA across 3, 6, and 12 months using mixed effects modeling.

Time frame
At 3, 6, and 12 months post-randomization
3

Self-reported 7-day PPA from ENDS use

Will investigate repeated 30-day PPA across 3, 6, and 12 months using mixed effects modeling.

Time frame
At 3, 6, and 12 months post-randomization
4

Self-reported 30-day PPA from ENDS use

Will investigate repeated 30-day PPA across 3, 6, and 12 months using mixed effects modeling.

Time frame
At 3, 6, and 12 months post-randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fred Hutchinson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Endeavor Health

Collaborator

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