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Tobacco-Related CarcinomaNCT07571018

A Novel Mobile Health Intervention for Improving Tobacco Cessation Among Young Adults

A study testing Smartphone app-based Intervention, Communication intervention and Survey Administration in people with Tobacco-Related Carcinoma, run by Fred Hutchinson Cancer Center at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Tobacco-Related Carcinoma
What is being tested?
Smartphone app-based Intervention, Communication intervention and Survey Administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
2 sitesUnited States
Study dates
7 Jun 2026to 11 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
  • USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Participants must self-report having internet access for the interviews
  • USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Participants must self-report that they are interested in participating in the study for themselves (versus [vs] someone else)
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  • USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Participants must self-report that they have not participated in one of our prior tobacco cessation studies
  • USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Participants must self-report that they understand and agree to the conditions of compensation
  • USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Participants must self-report that they are not currently incarcerated
  • USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: Participants must be willing and able to complete study procedures in English
  • PILOT TRIAL: Participants must self-identify being between 18 and 30 years of age
  • PILOT TRIAL: Participants must currently reside in the US and anticipate continued residence for the duration of the study (3 months)
  • PILOT TRIAL: 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
  • PILOT TRIAL: Participants must own an Android (running version 12 or higher) or iPhone (running iOS version 17 or higher, iPhone 11 or more recent)
  • PILOT TRIAL: Participants must self-report having at least weekly internet access for the next three months
  • PILOT TRIAL: Participants must be willing and able to download an app to their phone and receive text messages
  • PILOT TRIAL: Participants must self-report current use of a personal email account
  • PILOT TRIAL: Participants must self-report current use of text messaging
  • PILOT TRIAL: Participants must self-report that they are interested in participating in the study for themselves (vs someone else)
  • PILOT TRIAL: Participants must self-report that they have not participated in one of our prior tobacco cessation studies
  • PILOT TRIAL: Participants must self-report that they understand and agree to the conditions of compensation
  • PILOT TRIAL: Participants must self-report that they are not currently incarcerated
  • PILOT TRIAL: Participants must be willing to use the assigned intervention program, complete the study assessments, and complete an online consent form in English
  • POST PILOT TRIAL DIARY STUDY: Participants must self-identify being between 18 and 30 years of age
  • POST PILOT TRIAL DIARY STUDY: Participants must currently reside in the US
  • POST PILOT TRIAL DIARY STUDY: 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
  • POST PILOT TRIAL DIARY STUDY: Participants must own an Android (running version 12 or higher) or iPhone (running iOS version 17 or higher, iPhone 11 or more recent)
  • POST PILOT TRIAL DIARY STUDY: Participants must self-report having at least internet access for the duration of the diary study
  • POST PILOT TRIAL DIARY STUDY: Participants must be willing and able to download an app to their phone and receive text messages
  • POST PILOT TRIAL DIARY STUDY: Participants must self-report current use of a personal email account
  • POST PILOT TRIAL DIARY STUDY: Participants must self-report current use of text messaging
  • POST PILOT TRIAL DIARY STUDY: Participants must self-report that they are interested in participating in the study for themselves (vs someone else)
  • POST PILOT TRIAL DIARY STUDY: Participants must self-report that they have not participated in one of our prior tobacco cessation studies
  • POST PILOT TRIAL DIARY STUDY: Participants must self-report that they understand and agree to the conditions of compensation
  • POST PILOT TRIAL DIARY STUDY: Participants must self-report that they are not currently incarcerated
  • POST PILOT TRIAL DIARY STUDY: Participants must be willing to use the intervention program, complete the study assessments, and complete an online consent form in English

Who cannot join

  • 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
  • PILOT TRIAL: Participants must not be currently using other tobacco cessation treatments at the time of screening, including pharmacotherapy or behavioral support (but initiating these treatments during the study is allowed)
  • PILOT TRIAL: Participants must not be a member of the same household as another research participant
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  • PILOT TRIAL: Participants must not have a Google voice number as their sole phone number
  • PILOT TRIAL: Participants must not be identified as fraudulent per our fraud prevention protocol
  • PILOT TRIAL: Participants must not be pregnant or plan on becoming pregnant over the next 3 months
  • POST PILOT TRIAL DIARY STUDY: Individuals must not be < 18 or > 30 years of age
  • POST PILOT TRIAL DIARY STUDY: Participants must not have a Google voice number as their sole phone number
  • POST PILOT TRIAL DIARY STUDY: Individuals who are non-English speaking cannot participate, as this would prevent their participation in the interviews, which will be conducted in English

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • New Mexico State University

    Las Cruces, New Mexico, 88003

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: Development and Pilot Evaluation of a Novel Mobile Health Intervention for Young Adult Tobacco Cessation

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.

Read the detailed description

OUTLINE: Participants are assigned to 1 of 3 phases.

USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT PHASE (Objective 1): Participants attend user testing interviews where they interact with LiFT application (app) prototypes and provide feedback through think-aloud methods to support refinement of the intervention content and features.

PILOT TRIAL PHASE (Objective 2): Participants are randomized to 1 of 2 arms.

  • ARM I: Participants use the LiFT A app, which includes interactive games and exercises, educational content, and tools tailored to young adults using an acceptance and commitment therapy (ACT) treatment approach, for 3 months. Participants also receive associated text messages 2-3 times per week.
  • ARM II: Participants use the LiFT B app, which includes educational resources on preparing to quit, nicotine withdrawal, coping with withdrawal, and mental health, along with health information videos, for 3 months. Participants also receive associated text messages 2-3 times per week.

POST PILOT TRIAL DIARY STUDY PHASE (Objective 3): Participants use the LiFT app and complete daily usability and satisfaction assessments for approximately 1 week. Participants also complete a survey and attend an interview.

Being tested
Smartphone app-based Intervention, Communication intervention, Survey Administration, Interview, Assessment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Smartphone app-based InterventionOther

    Use LiFT A app

  • Smartphone app-based InterventionOther

    Use LiFT B app

  • Communication interventionOther

    Receive LiFT A text messages

  • Communication interventionOther

    Receive LiFT B text messages

  • Survey AdministrationOther

    Complete surveys

  • InterviewOther

    Attend interview

  • AssessmentOther

    Complete usability assessment

  • Survey AdministrationOther

    Complete survey

Study groups in NCT07571018
Study groupRoleWhat they receive
User-centered design and program development phase (interview) [Objective 1]No interventionParticipants attend user testing interviews where they interact with LiFT app prototypes and provide feedback through think-aloud methods to support refinement of the intervention content and features.
Pilot phase, Arm I (LiFT A app, LiFT A text messages) [Objective 2]ExperimentalParticipants use the LiFT A app, which includes interactive games and exercises, educational content, and tools tailored to young adults using an ACT treatment approach, for 3 months. Participants also receive LiFT A text messages 2-3 times per week.
Receives: Other: Smartphone app-based Intervention; Other: Communication intervention; Other: Survey Administration
Pilot phase, Arm II (LiFT B app, LiFT B text messages) [Objective 2]ExperimentalParticipants use the LiFT B app, which includes educational resources on preparing to quit, nicotine withdrawal, coping with withdrawal, mental health, along with health information videos, for 3 months. Participants also receive LiFT B text messages 2-3 times per week.
Receives: Other: Smartphone app-based Intervention; Other: Communication intervention; Other: Survey Administration
Post pilot trial diary study phase (LiFT, survey, interview) [Objective 3]OtherParticipants use the LiFT app and complete daily usability and satisfaction assessments for approximately 1 week. Participants also complete a survey and attend an interview.
Receives: Other: Smartphone app-based Intervention; Other: Interview; Other: Assessment; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At 3 months

  2. 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.

    Measured: At 3 months

  3. 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.

    Measured: At 3 months

  4. 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.

    Measured: At 3 months

  5. Satisfaction with perceived tailoring (Pilot trial phase)

    The perception that the assigned program was made for someone like the participant 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.

    Measured: At 3 months

  6. Satisfaction with guidance on how to quit (Pilot trial phase)

    The perception that the program clarified how to quit nicotine/tobacco when ready 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.

    Measured: At 3 months

  7. Perception that program offered a novel approach to quitting (Pilot trial phase)

    The perception that the program offered a new way of looking at quitting 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.

    Measured: At 3 months

  8. Perceived helpfulness for quit preparation (Pilot trial phase)

    The perception that the program will help with quitting if/when ready 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.

    Measured: At 3 months

  9. Willingness to recommend program to a friend (Pilot trial phase)

    Whether the respondent would recommend the program to a friend will be assessed via responses of "yes," "no," or "not sure." Responses will be categorized into a binary variable representing "yes" versus other responses (i.e.,"no" or "not sure").

    Measured: At 3 months

  10. Usability (Post pilot trial diary study phase)

    Qualitative data from interviews, diary entries and exit interviews will be coded and analyzed using rapid inductive content analysis to extract themes. Usability data will be reported using descriptive statistics and compared against the benchmark score of 68, which represents average usability.

    Measured: At completion of post pilot trial diary study phase (At Day 9)

Secondary outcomes (8)
  1. 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.

    Measured: At 3 months

  2. 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.

    Measured: At 3 months

  3. 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.

    Measured: At 3 months

  4. 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.

    Measured: At 3 months

  5. Average change in Contemplation Ladder scores (Pilot trial phase)

    The outcome will be calculated as the 3-month follow-up minus baseline score on the 11-point Contemplation Ladder. Positive change scores indicate increases in readiness to quit, on average, whereas negative change scores indicate decreases in readiness to quit.

    Measured: From baseline to 3 months

  6. Change in acceptance of tobacco use triggers (Pilot trial phase)

    This outcome will be calculated as the 3-month follow-up minus baseline score on the cravings subscale of the Avoidance and Inflexibility Scale. Because avoidance and inflexibility represent the inverse of acceptance, positive change scores indicate a decrease in acceptance, on average, whereas negative change scores indicate increased acceptance of tobacco use triggers.

    Measured: From baseline to 3 months

  7. Change in values progress (Pilot trial phase)

    This outcome will be calculated as the 3-month follow-up minus baseline score the progress subscale of the Valuing Questionnaire. Positive change scores indicate increases in values progress, on average, whereas negative change scores indicate decreases in values progress.

    Measured: From baseline to 3 months

  8. Change in values obstruction (Pilot trial phase)

    This outcome will be calculated as the 3-month follow-up minus baseline score the values obstruction subscale of the Valuing Questionnaire. Positive change scores indicate increases in values obstruction, on average, whereas negative change scores indicate decreases in values obstruction.

    Measured: From baseline to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2026
  2. Study start7 Jun 2026
  3. Primary completion11 Jun 2026
  4. Study completion11 Jun 2026

Why it stopped: Discontinuation of funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
PILOT TRIAL: Parallel; USER-CENTERED DESIGN AND PROGRAM DEVELOPMENT: N/A; POST PILOT TRIAL DIARY STUDY: N/A
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07571018
Sponsor's protocol ID
RG1126140
Other IDs
NCI-2026-00801, U54CA132381
Status last verified
Oct 2026
First submitted
30 Apr 2026
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Smartphone app-based Intervention, Communication intervention and Survey Administration in people with Tobacco-Related Carcinoma, run by Fred Hutchinson Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 36 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Discontinuation of funding). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall satisfaction (Pilot trial phase) (time frame: At 3 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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