About this trial
Tobacco use is the leading cause of preventable cancer deaths. Among young adults, approximately 1 in 5 use commercial nicotine and tobacco products, putting them at risk of developing nicotine addiction and long-term health effects from exposure to toxicants. Innovative approaches are needed to engage young adults in treatment, as they are less engaged in traditional treatment.
This clinical trial compares two versions of a mobile health intervention called Living Free from Tobacco (LiFT), designed to support nicotine and tobacco cessation among young adults. Both versions of the app are designed to motivate and support young adults to stop using nicotine and tobacco, regardless of current readiness to quit. Version A of the LiFT app (LiFT A) focuses on increasing psychological flexibility to support cessation, while Version B (LiFT B) provides educational content and resources related to tobacco use and cessation. Both versions of the program are delivered through a smartphone application and include accompanying text messages.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Participants must self-identify being between 18 and 30 years of age
USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Participants must be a United States (US) resident, with a US mailing address
USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Participants must self-report use of any (non-therapeutic) nicotine or tobacco product at least once per week in the 30 days prior to screening
USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Participants must own a smartphone
Disqualifiers
USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Individuals must not be < 18 or > 30 years of age
USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Individuals must not have a Google voice number as their sole phone number
USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Individuals who are non-English speaking cannot participate, as this would prevent their participation in the interviews, which will be conducted in English
PILOT TRIAL: Participants must not be < 18 or > 30 years of age
Trial design
Parallel
Treatments tested in this trial
Smartphone app-based Intervention
Other interventionUse LiFT A app
Smartphone app-based Intervention
Other interventionUse LiFT B app
Communication intervention
Other interventionReceive LiFT A text messages
Communication intervention
Other interventionReceive LiFT B text messages
Survey Administration
Other interventionComplete surveys
Interview
Other interventionAttend interview
Assessment
Other interventionComplete usability assessment
Survey Administration
Other interventionComplete survey
Treatment groups
Trial outcomes
Primary outcomes
Overall satisfaction (Pilot trial phase)
Overall satisfaction with the assigned program will be assessed by self-report on a 5-point Likert-type scale from "not at all" (1) to "very much" (5) and summarized by arm using means and standard deviations.
Number of logins to assigned application (Pilot trial phase)
Treatment utilization will include number of logins to the assigned application, determined objectively using tracking software.
Usefulness of the program (Pilot trial phase)
The perceived usefulness of the assigned program will be assessed by self-report on a 5-point Likert-type scale from "not at all" (1) to "very much" (5) and summarized by arm using means and standard deviations.
Usefulness of text messages (Pilot trial phase)
The perceived usefulness of the assigned program's text messages will be assessed by self-report on a 5-point Likert-type scale from "not at all" (1) to "very much" (5) and summarized by arm using means and standard deviations.
Secondary outcomes
Biochemically-confirmed 7-day point prevalence abstinence (PPA) from all nicotine and tobacco use (Pilot trial phase)
Percentage of participants reporting abstinence from all nicotine and tobacco use (excluding Food and Drug Administration-approved pharmacotherapies) over the previous 7 days, biochemically confirmed via saliva cotinine.
Self-reported 7-day PPA from all nicotine and tobacco use (Pilot trial phase)
Percentage of participants reporting abstinence from all nicotine and tobacco use (excluding Food and Drug Administration-approved pharmacotherapies) over the previous 7 days.
Self-reported 30-day PPA (Pilot trial phase)
Percentage of participants reporting abstinence from all nicotine and tobacco use (excluding Food and Drug Administration-approved pharmacotherapies) over the previous 30 days.
Cotinine-confirmed 30-day PPA (Pilot trial phase)
Percentage of participants reporting abstinence from all nicotine and tobacco use (excluding Food and Drug Administration-approved pharmacotherapies) over the previous 30 days, biochemically confirmed via saliva cotinine.
Sponsors and contacts
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Fred Hutchinson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator