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

Vaping Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05967585
• Other study ID #: SJTIQ
• Secondary ID: NCI-2023-04799
• Status: Recruiting
• Phase: N/A
• Start date: August 4, 2023
• Est. completion date: April 5, 2027

Study information

• Verified date: August 2023
• Source: St. Jude Children's Research Hospital
• Contact: Rachel Webster, PhD
• Phone: 8662785833
• Email: referralinfo[@]stjude.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 5, 2027
• Est. primary completion date: April 5, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Vaping

Intervention

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.

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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]
Primary	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
Primary	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
Primary	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]
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Healthcare Provider Post-Intervention Interviews	Interviews will assess provider experience, barriers, and facilitators of developed implementation strategies	Phase 2, 4-weeks post implementation
Primary	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
Primary	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
Primary	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
Primary	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	Cancer-Related Worry	Cancer-related worry and fear of cancer recurrence will be assessed using the Cancer Worry Scale. The 6-item assessment measures participant fears of relapse, late-effects, and fertility concerns. Participants respond on a 4- point Likert scale with response options ranging from "strongly disagree" to "strongly agree." This measure has been successfully used with both adolescent and young adult populations and will inform the extent to which cancer-related worry is associated with e-cigarette use.	Baseline
Secondary	PROMIS profile-49	The Patient Reported Outcome Measurement Information System (PROMIS) Profile will be administered to assess self-reported physical functioning mobility, anxiety, depressive symptoms, fatigue, peer relationships, pain interference, and pain intensity over a 7-day period. Participants <18 will complete the self-reported pediatric version (49 items), and participants = 18 will complete the adult version (43 items). Items are summed and T-scored, have a mean of 50 and a standard deviation of 10. This assessment will help inform psychological components associated with vaping behaviors and interest in quitting that may support implementation processes	Baseline
Secondary	Social Influence and Support	Social support is a known protective factor against substance use, and social media influence can promote substance use. We will implement assessments to explore the association of social influence on vaping behaviors using the Multidimensional Scale of Perceived Social Support (MSPSS). The MSPSS is a 12-item self-report questionnaire that assesses perceived support from friends, family, and a significant other. Questions are answered on 7-point Likert scale from "very strongly disagree" to "very strongly agree." Higher scores are indicative of more social support. Additional items will be administered to assess social media influence on vaping behaviors.	Baseline
Secondary	Dietary Behaviors	The Investigators will use several brief dietary assessment to explore associations within this study.; Rapid Easting Assessment for Participants is used to quickly assess nutrient intake/diet quality in a clinical and research settings. It is completed for the previous week's food intake and scored by summing responses from 'usually/ often' to 'rarely/never or does not apply to me'. Possible scores ranged from 13 to 39 with a higher score indicating a higher diet quality. There is an additional 3-question section at the end about cooking/shopping and willingness to change eating habits.; The Binge Eating Scale includes 16 multiple choice items assessing the presence of certain binge eating behaviors which may be indicative of an eating disorder. Scores are summed for a maxi	Baseline
Secondary	Physical Activity Screener	Research has highlighted links between smoking cessation and increased physical activity in the general AYA population, and physical activity may be an important determinant in supporting vaping cessation. Understanding physical activity behaviors may provide additional mechanisms to improve vaping behaviors. As such, we will administer the International Physical Activity Questionnaire (IPAQ) short form is a 7-item self-reported questionnaire that assesses perceived health-related physical activity. Questions are answered based on the amount of reported minutes and/or hours per days participants engage in physical activity. Physical activity level is scored and categorized within three levels of activity: vigorous, moderate, and walking intensity. Scores can be converted to metabolic equivalents.	Baseline
Secondary	Healthcare Provider Characteristics	General demographic data will be gathered about health care providers including provider type (e.g., physician, psychologist, nurse practitioner), gender identity, and years of independent practice.	Baseline
Secondary	Cancer Event Scale	CES is a 20-item self-report questionnaire that assesses the extent to which the most stressful or impactful traumatic event experienced in participants' lives serves as a pivotal point in the development of their identity or influences their attribution of meaning to other events in their lives. For this questionnaire, participants will specifically answer questions about their cancer experience. Of the 20 items, 8 items assess the extent to which an event has become a reference point for the participant, 6 items assess the extent to which the event is central to participants' identity, and 6 items assess the extent to which participants think the event was a turning point in their life story. Questions are answered on a 5-point Likert scale ranging from " Totally Disagree" to "Totally Agree." No items are reverse coded and higher scores indicate greater centrality of the traumatic event to the participant.	Baseline; 1-week post TIQ program completion

External Links

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