An interventional study of Biospecimen Collection and Cognitive Assessment in Cigarette Smoking-Related Carcinoma, sponsored by Ohio State University Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years to 24 Years. Per ClinicalTrials.gov, last updated 2024-12-20.
Sponsored by Ohio State University Comprehensive Cancer Center · Not applicable, Interventional, and Prevention
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.
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.
Ohio State University Comprehensive Cancer Center is the lead sponsor of 375 studies on the registry; 82 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Acquired Brain Injury (ABI) (15 youth with and 15 without)
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.
Procedure: Biospecimen Collection · Procedure: Cognitive Assessment · Other: Interview · Drug: Nicotine Replacement · Behavioral: Smoking Cessation Intervention · Other: Survey Administration · Other: Tobacco Cessation Counseling
Undergo nasal swab collection
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo cognitive assessment
Ancillary studies
Given nicotine patches, gum, or lozenges
Also known as: Nicotine Replacement Therapy, NRT
Receive access to the Ohio Tobacco Quit Line
Also known as: Smoking and Tobacco Use Cessation Interventions
Ancillary studies
Participate in counseling sessions
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 8 weeks
Ran from Jun 2023 to primary completion in Aug 2023, 2 months.
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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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