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

QUEST (Quitting Using Executive Function Strategy Training) Research Protocol

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Prevention (QUEST); 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.

Other: Survey Administration; Ancillary studies; Other: Interview; Ancillary studies; Procedure: Cognitive Assessment; Undergo cognitive assessment; Procedure: Biospecimen Collection; Undergo nasal swab collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Drug: Nicotine Replacement; Given nicotine patches, gum, or lozenges; Other Names: Nicotine Replacement Therapy; NRT; Behavioral: Smoking Cessation Intervention; Receive access to the Ohio Tobacco Quit Line; Other Names: Smoking and Tobacco Use Cessation Interventions; Other: Tobacco Cessation Counseling; Participate in counseling sessions

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Julianna Nemeth, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2023
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: OSU-23119; NCI-2024-04793 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No