Implementing an Adolescent and Young Adult (AYA) mHealth Vaping Cessation Program Into Oncology Clinics
NCT05967585 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500
Last updated 2025-10-16
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
Interventions
- DEVICE
-
Behavioral: Quitting Program (TIQ)
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.
Sponsors & Collaborators
-
St. Jude Children's Research Hospital
lead OTHER
Principal Investigators
-
Rachel Webster, PhD · St. Jude Children's Research Hospital
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 13 Years
- Max Age
- 24 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-04
- Primary Completion
- 2026-04-05
- Completion
- 2027-04-05
- FDA Device
- Yes
Countries
- United States
Study Locations
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