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VapingNCT05967585

Implementing an Adolescent and Young Adult (AYA) mHealth Vaping Cessation Program Into Oncology Clinics

A study testing Behavioral: Quitting Program (TIQ) in people with Vaping and Vaping Cessation, run by St. Jude Children's Research Hospital at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to understand e-cigarette use and interest in quitting by exploring e vaping behaviors among a cohort of AYA survivors (N=500). The investigators will also examine demographic, medical, and psychosocial factors associated with vaping behaviors. Primary Objectives: Phase 1. Objective 1. Read more about this study

Who is it for?
Ages 13 to 24 years
Conditions the study is for
Vaping, Vaping Cessation
What is being tested?
Behavioral: Quitting Program (TIQ)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
539 participants
Where
1 siteUnited States
Study dates
4 Aug 2023to 5 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 13 to 24 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Study Participants
  • Research participant is 13 to 24 years old at enrollment
  • Research participant is followed by St. Jude Children's Research Hospital (SJCRH)
  • Research participant has a diagnosis of malignancy or a CNS neoplasm
  • Research participant has been identified by the Transition Oncology Program (TOP) as a patient transitioning off active cancer therapy and/or followed by After Completion of Therapy (ACT) Clinic, and/or participating in the St. Jude Lifetime Cohort Study (SJLIFE)
  • Research participant is in remission and at least 3 months from having completed cancer-directed therapy
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  • Participant can speak and read English
  • Healthcare Providers
  • Engaged in the healthcare of survivors seen through TOP, ACT, or SJLIFE

Who cannot join

  • Study Participants
  • Significant psychiatric or neurologic disorders that would impair compliance with study protocol as indicated by the medical chart

Trial locations and contacts

1 site in 1 country.

United States1 site
  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105

Other trials in United States

About this study

The purpose of this study is to understand e-cigarette use and interest in quitting by exploring e vaping behaviors among a cohort of AYA survivors (N=500). The investigators will also examine demographic, medical, and psychosocial factors associated with vaping behaviors.

Primary Objectives:

Read more

Phase 1.

  • Objective 1. Identify characteristics of adolescent and young adult childhood cancer survivors (AYA CCS) nicotine vaping behaviors (e.g., e-cigarette use, interest in quitting, and quit attempts) and associations with demographic (e.g., sex, race, socioeconomic status, LGBTQ+ identification), cancer-specific (e.g., diagnosis, treatment factors), and psychosocial and behavioral factors.
  • Objective 2. Develop strategies to improve implementation of an evidence-based, mHealth vaping cessation program within an AYA oncology clinic.
  • Objective 2a: Use qualitative interviews to explore patient preferences regarding program implementation (e.g., timing of assessment of vaping behavior, confidentiality, referral approach) and identify barriers to uptake.
  • Objective 2b: Interview and/or ask healthcare providers (e.g., practitioners, advanced practice providers, social workers practicing in AYA oncology settings) to complete open- ended questionnaires related to current processes (e.g., workflow), needs, and barriers for assessing e-cigarette use and vaping cessation referral processes. Evaluate healthcare providers' information needs, preferences, and tools needed for integrating e- cigarette assessment and cessation program referrals into current practice.

Phase 2.

  • Objective 3. Develop and test vaping assessment and referral implementation processes (developed from Objectives 1 \& 2)., and uptake of an established mHealth vaping cessation program
  • Objective 3a: Using qualitative and quantitative measures, we will assess the reach (% of eligible AYA CCS that enrolled in mHealth program), adoption (% providers making referrals), strategy potential (provider/patient perceptions of referral process; appropriateness of program for patients), and maintenance (barriers/facilitators to implementation) of the program.
Read the detailed description

Phase 1.

To understand the needs and interest of the targeted population, this mixed-method project will first examine e-cigarette use and interest in quitting among a cohort of AYA survivors who range in age from 13-24 on the day of consent and are at least 3 months post treatment completion. Research participants will complete study assessments via REDCap, a HIPAA-compliant, password-protected, data collection and storage platform. AYA survivors who endorse current vaping and desire to quit (N=25) and healthcare providers engaged in AYA oncology care (N=15), will be asked to complete questionnaires related to attitudes, beliefs, and knowledge about e-cigarette use.

Phase 2.

Using data gathered from Phase 1, study investigators will develop implementation strategies by leveraging Expert Recommendations for Implementing Change1 to test implementation processes including systematically assessing vaping behaviors and referring patients to an evidenced based vaping cessation program. Qualitative and quantitative measures will be completed by patients who complete the vaping cessation program and healthcare providers who are engaged in assessment/referral process. These assessments will inform the reach, adoption, and implementation of the program.

Being tested
Behavioral: Quitting Program (TIQ)
Medical subject headings
Vaping

What participants receive

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

  • Behavioral: Quitting Program (TIQ)Device

    Implementation processes developed in Phase 1 to develop assessment of vaping behaviors and referral to an evidence-based program for vaping cessation (TIQ) will be tested in Phase 2.

    TIQ program is a mHealth, text messaging based intervention. Users who enroll in this program will receive 1 to 2 messages per day with 3 messages sent on their quit date. Messages are tailored to users' age, enrollment date or quit date, and the vape product they use.

    Those not ready to quit receive 4 weeks of messages focused on building skills and confidence. Users who set a quit date receive messages for up to 6 weeks preceding the date and up to 8 weeks after that include encouragement, support, skill- and efficacy- building exercises, coping strategies, etc. Keywords such as COPE, STRESS, SLIP, and MORE can be used to request on-demand support.

Study groups in NCT05967585
Study groupRoleWhat they receive
Phase I and Phase IIExperimentalPhase 2: Implementation processes for assessing vaping behaviors and referring patients to a vaping cessation intervention (This is Quitting-TIQ) developed in Phase 1 will be tested within oncology survivorship clinics. Participants who opt to enroll in TIQ will also be asked to answer acceptability and applicability questions about their experience with the program.
Receives: Device: Behavioral: Quitting Program (TIQ)

What is being measured

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

  1. E-cigarette use

    Current e-cigarette use (yes/no). This question assesses whether or not a participant is currently using e-cigarettes.

    Measured: Baseline, 1-week post TIQ completion

  2. E-cigarette frequency

    E-cigarette frequency of use assesses how often a participant is using e-cigarettes (daily to less than monthly)

    Measured: Baseline; 1-week post TIQ program completion]

  3. Motivation and contemplation to quit

    These questions assess how motivated someone is to quit e-cigarettes (not all motivated to very motivated)

    Measured: Baseline; 1-week post TIQ program completion

  4. Prior history of e-cigarette quitting

    This assessment explores if a participant has tried to quit vaping and how many quit attempts were made. (yes/no; if yes, how many quit attempts)

    Measured: Phase 2, 4-weeks post implementation

  5. Patient Preferences for E-Cigarette Use Assessment and Referral Processes

    Semi-structured interviews will assess preferences for assessment of e-cigarette use within oncology clinic settings and referral for cessation programs.

    Measured: Baseline; 1-week post TIQ program completion]

  6. Healthcare Provider Perspectives of Program Implementation Potential

    The Feasibility of Intervention will be administered to healthcare providers to assess the potential utility and modifications needed for the developed implementation strategies. This brief 4-item questionnaire was designed to test implementation outcomes related to program feasibility. This questionnaire is considered a strong indicators of future implementation success and will be used to inform modifications for large scale testing of implementation processes in future research. Items on this assessment are routinely modified to match the specific implementation programming, and for this study were modified slightly to gauge healthcare provider perceptions of vaping assessment and referral processes to This is Quitting

    Measured: Baseline; 1-week post TIQ program completion

  7. E-cigarette expectancies

    Similar to the framework used by Harrell et al. positive (e.g., negative affect reduction, stimulation/state enhancement, stress reduction) and negative consequences (e.g., cost, addiction) associated with e-cigarette use will be evaluated using a 15-item questionnaire derived from the Smoking Consequences Questionnaire-Adult (SCQ-A). In addition items related to having had cancer were included in the questionnaire in line with prior research (e.g., "E-cigarettes help me reduce cancer-related stress."). Response options range on a 7-point Likert scale from "very strongly disagree" to "very strongly agree.

    Measured: Baseline

  8. Patient-Provider E-Cigarette Communication

    Motivation and contemplation to quit assess how motivated someone is to quit e-cigarettes (not all motivated to very motivated)

    Measured: Baseline

  9. Prior history of e-cigarette

    Prior history of e-cigarette quitting behaviors assesses how many times a participant has tried to quit (yes/no; if yes, how many quit attempts)

    Measured: Baseline; 1-week post TIQ program completion

  10. Patient Preferences for E-Cigarette Use Assessment and Referral Processes.

    Semi-structured interviews will assess preferences for assessment of e-cigarette use within oncology clinic settings and referral for cessation programs.

    Measured: Baseline

  11. Healthcare Provider Perceptions of Barriers to E-Cigarette Assessment and Referral Processes.

    Questionnaires will assess current processes and barriers to vaping assessments and referral to cessation programs, as well as information needs, preferences, and required tools.

    Measured: Baseline

  12. Healthcare Provider Post-Intervention Interviews

    Interviews will assess provider experience, barriers, and facilitators of developed implementation strategies

    Measured: Phase 2, 4-weeks post implementation

  13. Healthcare Provider Perspectives of Program Implementation Potential

    The Feasibility of Intervention will be administered to healthcare providers to assess the potential utility and modifications needed for the developed implementation strategies. This brief 4-item questionnaire was designed to test implementation outcomes related to program feasibility. This questionnaire is considered a strong indicator of future implementation success and will be used to inform modifications for large scale testing of implementation processes in future research. Items on this assessment are routinely modified to match the specific implementation programming, and for this study were modified slightly to gauge healthcare provider perceptions of vaping assessment and referral processes to This is Quitting

    Measured: Phase 2, 4 weeks Post-Implementation

  14. Healthcare Provider Attitudes, Beliefs, Knowledge, and Communication about E-cigarettes

    Items were modified from previous research to assess patient-doctor communication surrounding e-cigarette use including interest, comfort, and importance of these discussions. Questions also assessed for discussions related to use, referral for quitting support, and attitudes/beliefs about e-cigarette risk.

    Measured: Baseline

  15. Patient-Provider E-Cigarette Communication

    The Acceptability of Intervention Measure and Intervention Appropriateness Measures will be administered to evaluate implementation potential of the vaping cessation program. These brief 4-item questionnaires were designed to test implementation outcomes related to program acceptability and appropriateness. They are considered strong indicators of future implementation success and will be used to inform modifications. Items on this assessment are routinely modified to match the specific implementation programming, and for this study were modified slightly to gauge participant perceptions of This is Quitting.

    Measured: 1-week post TIQ program completion

  16. Satisfaction Survey

    This survey will evaluate patient participant perspectives on satisfaction of TIQ programming including types of messages and frequency of messaging, and the degree the program was helpful in reducing vaping.

    Measured: 1-week post TIQ program completion

Secondary outcomes (7)
  1. Cancer-Related Worry

    Cancer-related worry and fear of cancer recurrence will be assessed using the Cancer Worry Scale. The 6-item assessment measures participant fears of relapse, late-effects, and fertility concerns. Participants respond on a 4- point Likert scale with response options ranging from "strongly disagree" to "strongly agree." This measure has been successfully used with both adolescent and young adult populations and will inform the extent to which cancer-related worry is associated with e-cigarette use.

    Measured: Baseline

  2. PROMIS profile-49

    The Patient Reported Outcome Measurement Information System (PROMIS) Profile will be administered to assess self-reported physical functioning mobility, anxiety, depressive symptoms, fatigue, peer relationships, pain interference, and pain intensity over a 7-day period. Participants <18 will complete the self-reported pediatric version (49 items), and participants ≥ 18 will complete the adult version (43 items). Items are summed and T-scored, have a mean of 50 and a standard deviation of 10. This assessment will help inform psychological components associated with vaping behaviors and interest in quitting that may support implementation processes

    Measured: Baseline

  3. Social Influence and Support

    Social support is a known protective factor against substance use, and social media influence can promote substance use. We will implement assessments to explore the association of social influence on vaping behaviors using the Multidimensional Scale of Perceived Social Support (MSPSS). The MSPSS is a 12-item self-report questionnaire that assesses perceived support from friends, family, and a significant other. Questions are answered on 7-point Likert scale from "very strongly disagree" to "very strongly agree." Higher scores are indicative of more social support. Additional items will be administered to assess social media influence on vaping behaviors.

    Measured: Baseline

  4. Dietary Behaviors

    The Investigators will use several brief dietary assessment to explore associations within this study.

    Rapid Easting Assessment for Participants is used to quickly assess nutrient intake/diet quality in a clinical and research settings. It is completed for the previous week's food intake and scored by summing responses from 'usually/ often' to 'rarely/never or does not apply to me'. Possible scores ranged from 13 to 39 with a higher score indicating a higher diet quality. There is an additional 3-question section at the end about cooking/shopping and willingness to change eating habits.

    The Binge Eating Scale includes 16 multiple choice items assessing the presence of certain binge eating behaviors which may be indicative of an eating disorder. Scores are summed for a maxi

    Measured: Baseline

  5. Physical Activity Screener

    Research has highlighted links between smoking cessation and increased physical activity in the general AYA population, and physical activity may be an important determinant in supporting vaping cessation. Understanding physical activity behaviors may provide additional mechanisms to improve vaping behaviors. As such, we will administer the International Physical Activity Questionnaire (IPAQ) short form is a 7-item self-reported questionnaire that assesses perceived health-related physical activity. Questions are answered based on the amount of reported minutes and/or hours per days participants engage in physical activity. Physical activity level is scored and categorized within three levels of activity: vigorous, moderate, and walking intensity. Scores can be converted to metabolic equivalents.

    Measured: Baseline

  6. Healthcare Provider Characteristics

    General demographic data will be gathered about health care providers including provider type (e.g., physician, psychologist, nurse practitioner), gender identity, and years of independent practice.

    Measured: Baseline

  7. Cancer Event Scale

    CES is a 20-item self-report questionnaire that assesses the extent to which the most stressful or impactful traumatic event experienced in participants' lives serves as a pivotal point in the development of their identity or influences their attribution of meaning to other events in their lives. For this questionnaire, participants will specifically answer questions about their cancer experience. Of the 20 items, 8 items assess the extent to which an event has become a reference point for the participant, 6 items assess the extent to which the event is central to participants' identity, and 6 items assess the extent to which participants think the event was a turning point in their life story. Questions are answered on a 5-point Likert scale ranging from " Totally Disagree" to "Totally Agree." No items are reverse coded and higher scores indicate greater centrality of the traumatic event to the participant.

    Measured: Baseline; 1-week post TIQ program completion

Timeline

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

  1. First posted1 Aug 2023
  2. Study start4 Aug 2023
  3. Primary completion15 Mar 2026
  4. Study completion5 Apr 2027 (estimated)

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
539 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05967585
Sponsor's protocol ID
SJTIQ
Other IDs
NCI-2023-04799
Status last verified
Jun 2026
First submitted
7 Jul 2023
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral: Quitting Program (TIQ) in people with Vaping and Vaping Cessation, run by St. Jude Children's Research Hospital at 1 site 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 9 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

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?

E-cigarette use (time frame: Baseline, 1-week post TIQ completion). The study lists 16 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 17 Jun 2026.

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