Clinical trial NCT05967585: Implementing an Adolescent and Young Adult (AYA) mHealth Vaping Cessation Program Into Oncology Clinics
Official title: Implementing an Adolescent and Young Adult (AYA) mHealth Vaping Cessation Program Into Oncology Clinics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vaping
Vaping Cessation
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 500
Sex: ALL
Minimum age (years): 13
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Study Participants

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

Primary outcomes:
measure: E-cigarette use
timeFrame: Baseline, 1-week post TIQ completion
measure: E-cigarette frequency
timeFrame: Baseline; 1-week post TIQ program completion]
measure: Motivation and contemplation to quit
timeFrame: Baseline; 1-week post TIQ program completion
measure: Prior history of e-cigarette quitting
timeFrame: Phase 2, 4-weeks post implementation
measure: Patient Preferences for E-Cigarette Use Assessment and Referral Processes
timeFrame: Baseline; 1-week post TIQ program completion]
measure: Healthcare Provider Perspectives of Program Implementation Potential
timeFrame: Baseline; 1-week post TIQ program completion
measure: E-cigarette expectancies
timeFrame: Baseline
measure: Patient-Provider E-Cigarette Communication
timeFrame: Baseline
measure: Prior history of e-cigarette
timeFrame: Baseline; 1-week post TIQ program completion
measure: Patient Preferences for E-Cigarette Use Assessment and Referral Processes.
timeFrame: Baseline
measure: Healthcare Provider Perceptions of Barriers to E-Cigarette Assessment and Referral Processes.
timeFrame: Baseline
measure: Healthcare Provider Post-Intervention Interviews
timeFrame: Phase 2, 4-weeks post implementation
measure: Healthcare Provider Perspectives of Program Implementation Potential
timeFrame: Phase 2, 4 weeks Post-Implementation
measure: Healthcare Provider Attitudes, Beliefs, Knowledge, and Communication about E-cigarettes
timeFrame: Baseline
measure: Patient-Provider E-Cigarette Communication
timeFrame: 1-week post TIQ program completion
measure: Satisfaction Survey
timeFrame: 1-week post TIQ program completion
Secondary outcomes:
measure: Cancer-Related Worry
timeFrame: Baseline
measure: PROMIS profile-49
timeFrame: Baseline
measure: Social Influence and Support
timeFrame: Baseline
measure: Dietary Behaviors
timeFrame: Baseline
measure: Physical Activity Screener
timeFrame: Baseline
measure: Healthcare Provider Characteristics
timeFrame: Baseline
measure: Cancer Event Scale
timeFrame: Baseline; 1-week post TIQ program completion
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Rachel Webster, PhD
role: PRINCIPAL_INVESTIGATOR
References: