Implementing an Adolescent and Young Adult (AYA) mHealth Vaping Cessation Program Into Oncology Clinics
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 539
- 试验地点
- 2
- 主要终点
- Prior history of e-cigarette quitting
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Study Participants
- •Significant psychiatric or neurologic disorders that would impair compliance with study protocol as indicated by the medical chart
研究组 & 干预措施
Phase I and Phase II
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.
干预措施: Behavioral: Quitting Program (TIQ) (Device)
结局指标
主要结局
Prior history of e-cigarette quitting
时间窗: Phase 2, 4-weeks post implementation
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)
Healthcare Provider Perspectives of Program Implementation Potential
时间窗: Phase 2, 4 weeks Post-Implementation
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
Prior history of e-cigarette
时间窗: Baseline; 1-week post TIQ program completion
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)
Healthcare Provider Post-Intervention Interviews
时间窗: Phase 2, 4-weeks post implementation
Interviews will assess provider experience, barriers, and facilitators of developed implementation strategies
E-cigarette use
时间窗: Baseline, 1-week post TIQ completion
Current e-cigarette use (yes/no). This question assesses whether or not a participant is currently using e-cigarettes.
E-cigarette frequency
时间窗: Baseline; 1-week post TIQ program completion]
E-cigarette frequency of use assesses how often a participant is using e-cigarettes (daily to less than monthly)
Healthcare Provider Attitudes, Beliefs, Knowledge, and Communication about E-cigarettes
时间窗: Baseline
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.
Motivation and contemplation to quit
时间窗: Baseline; 1-week post TIQ program completion
These questions assess how motivated someone is to quit e-cigarettes (not all motivated to very motivated)
Healthcare Provider Perceptions of Barriers to E-Cigarette Assessment and Referral Processes.
时间窗: Baseline
Questionnaires will assess current processes and barriers to vaping assessments and referral to cessation programs, as well as information needs, preferences, and required tools.
Patient-Provider E-Cigarette Communication
时间窗: 1-week post TIQ program completion
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.
Patient Preferences for E-Cigarette Use Assessment and Referral Processes
时间窗: Baseline; 1-week post TIQ program completion]
Semi-structured interviews will assess preferences for assessment of e-cigarette use within oncology clinic settings and referral for cessation programs.
E-cigarette expectancies
时间窗: Baseline
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.
Patient Preferences for E-Cigarette Use Assessment and Referral Processes.
时间窗: Baseline
Semi-structured interviews will assess preferences for assessment of e-cigarette use within oncology clinic settings and referral for cessation programs.
Satisfaction Survey
时间窗: 1-week post TIQ program completion
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.
次要结局
- Dietary Behaviors(Baseline)
- Physical Activity Screener(Baseline)
- PROMIS profile-49(Baseline)
- Social Influence and Support(Baseline)
- Healthcare Provider Characteristics(Baseline)
- Cancer Event Scale(Baseline; 1-week post TIQ program completion)
- Cancer-Related Worry(Baseline)