Tobacco-Related Carcinoma
Conditions
Brief summary
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.
Detailed description
OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants download and install the QuitQuest app for 12 months on study. ARM II: Participants utilize the National Cancer Institute's (NCI's) SFTQV app for 12 months on study.
Interventions
Use QuitQuest app
OTHERSurvey Administration
Ancillary studies
OTHERInterview
Ancillary studies
Sponsors
Fred Hutchinson Cancer Center
National Cancer Institute (NCI)
Endeavor Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 * Interest in learning skills to quit ENDS * Willing to be randomly assigned to either condition * Resides in the United States (US) for the next 12 months * Has daily access to their own smartphone * Ability to download a smartphone app * Able to read in English * Not using other ENDS cessation interventions * Have not participated in our prior studies * No household or family member participating * Willingness to complete survey and biochemical assessments at 3, 6, and 12 months * Providing phone number(s), email, and mailing address
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported 30-day point prevalence abstinence (PPA) from electronic nicotine delivery systems (ENDS) use | At 6 months post-randomization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported 24-hour PPA from ENDS use | At 3, 6, and 12 months post-randomization | Will investigate repeated 30-day PPA across 3, 6, and 12 months using mixed effects modeling. |
| Self-reported 7-day PPA from ENDS use | At 3, 6, and 12 months post-randomization | Will investigate repeated 30-day PPA across 3, 6, and 12 months using mixed effects modeling. |
| Biochemical verification of self-reported abstinence among participants who opt in at baseline and complete testing | Up to 12 months post-randomization | — |
| Self-reported 30-day PPA from ENDS use | At 3 and 12 months post-randomization | Will investigate repeated 30-day PPA across 3, 6, and 12 months using mixed effects modeling. |
Countries
United States
Contacts
CONTACTJonathan Bricker, PhD
PRINCIPAL_INVESTIGATORJonathan Bricker, PhD
Fred Hutch/University of Washington Cancer Consortium
PRINCIPAL_INVESTIGATORSean David, MD
Endeavor Health Clinical Operations
Outcome results
None listed