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

No results posted yet for this study

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05967585 on ClinicalTrials.gov