Evaluating the Impact of Quitting Using Executive Function Strategy Training (QUEST) on Smoking Cessation in Homeless Young Adult Smokers

Not Applicable

Completed

• Conditions: Cigarette Smoking-Related Carcinoma
• Interventions: Procedure: Biospecimen Collection; Procedure: Cognitive Assessment; Other: Interview; Drug: Nicotine Replacement; Behavioral: Smoking Cessation Intervention; Other: Survey Administration; Other: Tobacco Cessation Counseling

• Registration Number: NCT06745154
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary

This clinical trial evaluates the impact of Quitting Using Executive Function Strategy Training (QUEST) on quitting smoking (cessation) in homeless young adult smokers with an acquired brain injury (ABI). Over 70% of youth and young adults experiencing homelessness (YYEH) smoke tobacco. More than half of YYEH who smoke have made at least one attempt to quit smoking but few use evidence-based methods to increase success. In addition, 9 out of 10 of these have an acquired brain injury which may have a negative impact on successful smoking cessation. QUEST may help homeless young adult smokers with an ABI quit smoking.

Detailed Description

PRIMARY OBJECTIVES:

I. Gather data needed to build QUEST (Quitting Using Executive function Strategy Training), an intervention to help youth and young adults (YYEH) with executive function dysregulation better 1) access evidence-based cessation; 2) adhere to processes of evidence-based treatment; and 3) address stress to prevent relapse.

II. Establish the feasibility of collecting acquired brain injury (ABI) status, and impact data sensitive to change over time (clinical and epigenetic), from YYEH tobacco users in community settings.

EXPLORATORY OBJECTIVE:

I. Determine if 1) executive functioning 2) mild cognitive impairment and 3) epigenetic age \& other biomarkers of health risk measures are sensitive to difference by ABI status among YYEH past week combustible tobacco users.

OUTLINE:

Patients receive access to the Ohio Tobacco Quitline, receive nicotine patches, gum, or lozenges for up to 8 weeks. Patients also participate in tobacco cessation counseling sessions for 5 sessions over 8 weeks. Patients additionally undergo cognitive assessment and nasal swab collection on study.

Study Timeline

• Study Start: 2023-06-26
• Primary Completion: 2023-08-30
• Study Completion: 2023-08-30
• Status Verified: 2024-12
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• 18-24 years old

• Utilizing STAR House ( a drop-in center for youth and young adults experiencing homelessness) services

• Use of combustible tobacco product in the last week

• Willing to quit smoking in the next 30 days

• Acquired Brain Injury (ABI) (15 youth with and 15 without)

  • CHATS will be used to determine ABI. Ask "C", "H" and "A" of the CHATS tool. If yes to C OR H and yes to A, that will be considered positive for ABI

• Have access to a phone

• Willing to use phone for QuitLine (QL) services

• Willing to enroll in Ohio Tobacco Quit Line

• Willing to share Ohio Tobacco Quit Line portal data with researchers

• Willing to provide biospecimens (exhaled air and nasal samples)

• Conversational English skills

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prevention (QUEST)	Biospecimen Collection	Patients receive access to the Ohio Tobacco Quitline, receive nicotine patches, gum, or lozenges for up to 8 weeks. Patients also participate in tobacco cessation counseling sessions for 5 sessions over 8 weeks. Patients additionally undergo cognitive assessment and nasal swab collection on study.
Prevention (QUEST)	Cognitive Assessment	Patients receive access to the Ohio Tobacco Quitline, receive nicotine patches, gum, or lozenges for up to 8 weeks. Patients also participate in tobacco cessation counseling sessions for 5 sessions over 8 weeks. Patients additionally undergo cognitive assessment and nasal swab collection on study.
Prevention (QUEST)	Interview	Patients receive access to the Ohio Tobacco Quitline, receive nicotine patches, gum, or lozenges for up to 8 weeks. Patients also participate in tobacco cessation counseling sessions for 5 sessions over 8 weeks. Patients additionally undergo cognitive assessment and nasal swab collection on study.
Prevention (QUEST)	Nicotine Replacement	Patients receive access to the Ohio Tobacco Quitline, receive nicotine patches, gum, or lozenges for up to 8 weeks. Patients also participate in tobacco cessation counseling sessions for 5 sessions over 8 weeks. Patients additionally undergo cognitive assessment and nasal swab collection on study.
Prevention (QUEST)	Smoking Cessation Intervention	Patients receive access to the Ohio Tobacco Quitline, receive nicotine patches, gum, or lozenges for up to 8 weeks. Patients also participate in tobacco cessation counseling sessions for 5 sessions over 8 weeks. Patients additionally undergo cognitive assessment and nasal swab collection on study.
Prevention (QUEST)	Survey Administration	Patients receive access to the Ohio Tobacco Quitline, receive nicotine patches, gum, or lozenges for up to 8 weeks. Patients also participate in tobacco cessation counseling sessions for 5 sessions over 8 weeks. Patients additionally undergo cognitive assessment and nasal swab collection on study.
Prevention (QUEST)	Tobacco Cessation Counseling	Patients receive access to the Ohio Tobacco Quitline, receive nicotine patches, gum, or lozenges for up to 8 weeks. Patients also participate in tobacco cessation counseling sessions for 5 sessions over 8 weeks. Patients additionally undergo cognitive assessment and nasal swab collection on study.

Primary Outcome Measures

Name	Time	Method
Rate of executive function difficulties	Up to 8 weeks	The number of times participants experience executive function difficulties with adhering to the Quit Line protocol will be recorded via survey questionnaires.
Factors impacting access to evidence-based treatment	Up to 8 weeks	All factors reported by participants via survey questionnaires that impacted their ability to access Quit Line treatment will be recorded.
Contact with Quitline	Up to 8 weeks	The number of contacts each participant had with the Quit Line throughout the study will be recorded via survey questionnaires.
Use of nicotine replacement therapy	Up to 8 weeks	The number of times participants made use of nicotine replacement therapies throughout the length of the study will be recorded via survey questionnaires.

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States