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

NCT05967585 | Recruiting FDA Device

• 2 other identifiers: SJTIQNCI-2023-04799
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Vaping; Vaping Cessation

Outcome Measures

Primary Outcomes (16)

• E-cigarette use

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

  Baseline, 1-week post TIQ completion

• E-cigarette frequency

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

  Baseline; 1-week post TIQ program completion]

• Motivation and contemplation to quit

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

  Baseline; 1-week post TIQ program completion

• 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)

  Phase 2, 4-weeks post implementation

• 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.

  Baseline; 1-week post TIQ program completion]

• 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

  Baseline; 1-week post TIQ program completion

• 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.

  Baseline

• 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)

  Baseline

• 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)

  Baseline; 1-week post TIQ program completion

• 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.

  Baseline

• 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.

  Baseline

• Healthcare Provider Post-Intervention Interviews

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

  Phase 2, 4-weeks post implementation

• 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

  Phase 2, 4 weeks Post-Implementation

• 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.

  Baseline

• 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.

  1-week post TIQ program completion

• 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.

  1-week post TIQ program completion

Secondary Outcomes (7)

• Cancer-Related Worry

  Baseline

• PROMIS profile-49

  Baseline

• Social Influence and Support

  Baseline

• Dietary Behaviors

  Baseline

• Physical Activity Screener

  Baseline

Study Arms (1)

Phase I and Phase II

EXPERIMENTAL

Phase 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.

Device: Behavioral: Quitting Program (TIQ)

Interventions

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.

Phase I and Phase II

Eligibility Criteria

• Age: 13 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• Participant can speak and read English
• Healthcare Providers
• Engaged in the healthcare of survivors seen through TOP, ACT, or SJLIFE

You may not qualify if:

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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

Smoking; Behavior

Study Officials

• Rachel Webster, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Webster, PhD

CONTACT

8662785833; referralinfo@stjude.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: August 1, 2023
• Study Start: August 4, 2023
• Primary Completion: April 5, 2026
• Study Completion (Estimated): April 5, 2027
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available at the time of article publication.
• Access Criteria: Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.

Locations

US (1)