Cigarette Smoking-Related CarcinomaNCT06745154
Evaluating the Impact of Quitting Using Executive Function Strategy Training (QUEST) on Smoking Cessation in Homeless Young Adult Smokers
A study testing Biospecimen Collection, Cognitive Assessment and Interview in people with Cigarette Smoking-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Cigarette Smoking-Related Carcinoma
- What is being tested?
- Biospecimen Collection, Cognitive Assessment and Interview
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2023to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Cigarette Smoking-Related Carcinoma
- Being tested
- Biospecimen Collection, Cognitive Assessment, Interview, Nicotine Replacement, Smoking Cessation Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo nasal swab collection
Cognitive AssessmentProcedure or surgery
Undergo cognitive assessment
InterviewOther
Ancillary studies
Nicotine ReplacementDrug
Also called Nicotine Replacement Therapy, NRT
Given nicotine patches, gum, or lozenges
Smoking Cessation InterventionBehavioural
Also called Smoking and Tobacco Use Cessation Interventions
Receive access to the Ohio Tobacco Quit Line
Survey AdministrationOther
Ancillary studies
Tobacco Cessation CounselingOther
Participate in counseling sessions
| Study group | Role | What they receive |
|---|---|---|
| Prevention (QUEST) | Experimental | 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. Receives: Procedure: Biospecimen Collection; Procedure: Cognitive Assessment; Other: Interview; Drug: Nicotine Replacement; Behavioral: Smoking Cessation Intervention; Other: Survey Administration; Other: Tobacco Cessation Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start26 Jun 2023
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette Smoking-Related CarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julianna Nemeth, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745154
- Sponsor's protocol ID
- OSU-23119
- Other IDs
- NCI-2024-04793
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QUEST (Quitting Using Executive Function Strategy Training) Research Protocol
- ClinicalTrials.gov ID
- NCT06745154
- Acronym / sponsor ID
- OSU-23119
- Conditions
- Cigarette Smoking-Related Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevention (QUEST) | Experimental | Procedure: Biospecimen Collection, Procedure: Cognitive Assessment, Other: Interview, Drug: Nicotine Replacement, Behavioral: Smoking Cessation Intervention, Other: Survey Administration, Other: Tobacco Cessation CounselingPatients 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo nasal swab collection | Procedure or surgery | Prevention (QUEST) |
| Cognitive AssessmentUndergo cognitive assessment | Procedure or surgery | Prevention (QUEST) |
| InterviewAncillary studies | Other | Prevention (QUEST) |
| Nicotine ReplacementAlso: Nicotine Replacement Therapy, NRTGiven nicotine patches, gum, or lozenges | Drug | Prevention (QUEST) |
| Smoking Cessation InterventionAlso: Smoking and Tobacco Use Cessation InterventionsReceive access to the Ohio Tobacco Quit Line | Behavioural | Prevention (QUEST) |
| Survey AdministrationAncillary studies | Other | Prevention (QUEST) |
| Tobacco Cessation CounselingParticipate in counseling sessions | Other | Prevention (QUEST) |
Primary outcome
Rate of executive function difficulties
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- The JameslineLink provided by the sponsor.
Related trials for Cigarette Smoking-Related Carcinoma
Not yet recruitingPhase 3
iCanQuit Smoking Cessation Among Hispanic Adults
Cigarette Smoking-Related Carcinoma
Not yet recruiting
Studying Different Ways of Using Oral Nicotine Pouches to Understand the Effect on Nicotine Delivery, Appeal, and Side Effects Among Adult Cigarette Smokers
Cigarette Smoking-Related Carcinoma
RecruitingEarly Phase 1
Sensory Tests of Cigarettes for Identification of Flavors in Current Daily Smoking Adults
Cigarette Smoking-Related Carcinoma
Not yet recruiting
A Smartphone Application (QuitBot) for the Improvement of Smoking Cessation Among American Indians and Alaska Natives, NAITIVE Trial
Cigarette Smoking-Related Carcinoma
RecruitingPhase 3
Reaching Rural Cancer Survivors Who Smoke Using Text-Based Program
Cigarette Smoking-Related Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julianna Nemeth, PhD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biospecimen Collection, Cognitive Assessment and Interview in people with Cigarette Smoking-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of executive function difficulties (time frame: Up to 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.