Cigarette Smoking-Related CarcinomaNCT07455513
A Novel Tobacco Cessation Resource for Smokers With a Diagnosed or Suspected Thoracic Cancer
A study testing Electronic Health Record Review, Informational Intervention and Interview in people with Cigarette Smoking-Related Carcinoma and Malignant Thoracic Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial evaluates the feasibility of a novel tobacco cessation resource called a Buckeye Quit Stick among smokers with a diagnosed or suspected thoracic cancer. Tobacco use is the single most preventable cause of disease, disability, and death in the United States. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cigarette Smoking-Related Carcinoma, Malignant Thoracic Neoplasm
- What is being tested?
- Electronic Health Record Review, Informational Intervention and Interview
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >= 21 years old
- Speak and understand English
- Established patient of the OSU thoracic clinics
- Diagnosed with a thoracic malignancy or has a clinically suspected thoracic malignancy as documented by treating provider
- Willing and able to participate in the study protocol (e.g., complete the survey and related study documents and provide informed consent)
- Current self-reported smoker
- Willingness to change = score of above 1 on the Stages of Change measure
Who cannot join
- < 21 years old (Ohio is a tobacco 21 state.)
- Patient outside of the OSU clinics (This intervention targets patients who may benefit the most from cessation.)
- Unwilling or unable to provide consent or complete study components
- Prisoners will be excluded from participation
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: A Pilot/Feasibility Study of the Buckeye Quit Stick: A Novel Resource for Successful Tobacco Cessation
This clinical trial evaluates the feasibility of a novel tobacco cessation resource called a Buckeye Quit Stick among smokers with a diagnosed or suspected thoracic cancer. Tobacco use is the single most preventable cause of disease, disability, and death in the United States. While the benefits of quitting smoking are numerous, rates of persistent smoking after cancer diagnosis remain high. Research has found that patients who quit smoking but subsequently relapse frequently report the hand/oral habit as a barrier to sustained smoking cessation. The Buckeye Quit Stick is an innovative cessation aid designed to directly address patients' hand/oral habit by substituting the cessation aid for cigarettes without integrating pharmacologic intervention, which is typically managed by their medical provider and may require direct supervision due to the patient's health status. The Buckeye Quit Stick is designed to satisfy the repeated hand/oral pattern or ritual, thereby avoiding the physical loss of holding a cigarette in the hand or mouth and the action of smoking. It may also help occupy fidgeting hands and potentially reduce stress and cravings. This novel cessation resource may address key factors that influence smoking abstinence and improve patients' health outcomes.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the feasibility and acceptability of the Buckeye Quit Stick among 30 patients seen in the Ohio State University (OSU) thoracic clinic(s) and to characterize frequency of use among the accrued sample.
EXPLORATORY OBJECTIVES:
- Characterizing the population. II. Determining communication preferences, acceptance of the Buckeye Quit Stick, abstinence estimates.
III. Assessing the quality of subjective measures (e.g., anxiety, quality of life, etc.).
IV. Gathering qualitative data to elicit participant feedback regarding the device, The James Comprehensive Cancer Center (CCC) smoking cessation clinic, and overall study design.
OUTLINE:
Patients receive a Buckeye Quit Stick and a smoking cessation informational packet on study. Patients also receive a referral to the James CCC smoking cessation clinic on study.
After completion of study intervention, patients are followed up at 2 weeks, 3 and 6 months, and then up to 24 months.
- Being tested
- Electronic Health Record Review, Informational Intervention, Interview, Referral, Smoking Cessation Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Health Record ReviewOther
Ancillary studies
Informational InterventionOther
Receive smoking cessation information
InterviewOther
Ancillary studies
ReferralOther
Also called Referred
Receive referral
Smoking Cessation InterventionDevice
Also called Smoking and Tobacco Use Cessation Interventions
Receive Buckeye Quit Stick
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Prevention (Buckeye Quit Stick) | Experimental | Patients receive a Buckeye Quit Stick and a smoking cessation informational packet on study. Patients also receive a referral to the James CCC smoking cessation clinic on study. Receives: Other: Electronic Health Record Review; Other: Informational Intervention; Other: Interview; Other: Referral; Device: Smoking Cessation Intervention; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rates (feasibility)
To evaluate feasibility, recruitment rates will be defined as the proportion of screened adults accrued relative to those approached in the Ohio State University Comprehensive Cancer Center thoracic oncology clinic.
Measured: Up to 1 year
Adherence (feasibility)
Adherence will be assessed by evaluating the proportion of retained participants at each timepoint who complete required study procedures and assessments at each timepoint
Measured: at baseline, 2 weeks, 3 months and 6 months
Retention rates (feasibility)
Retention rates will be defined as the percentage of participants not lost to follow-up at 2-weeks, 3-months and 6-months post-enrollment. Descriptive statistics will be performed.
Measured: At 2 weeks, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start25 Feb 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
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
- 33 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Logan Roof, Ohio State University Comprehensive Cancer Center
- Investigators
- Logan Roof, MD, MS, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455513
- Sponsor's protocol ID
- OSU-25129
- Other IDs
- NCI-2026-00966
- Status last verified
- Sep 2026
- First submitted
- 24 Feb 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot/Feasibility Study of the Buckeye Quit Stick: A Novel Resource for Successful Tobacco Cessation
- ClinicalTrials.gov ID
- NCT07455513
- Acronym / sponsor ID
- OSU-25129
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 6 Mar 2026 (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 feasibility of a novel tobacco cessation resource called a Buckeye Quit Stick among smokers with a diagnosed or suspected thoracic cancer. Tobacco use is the single most preventable cause of disease, disability, and death in the United States. While the benefits of quitting smoking are numerous, rates of persistent smoking after cancer diagnosis remain high. Research has found that patients who quit smoking but subsequently relapse frequently report the hand/oral habit as a barrier to sustained smoking cessation. The Buckeye Quit Stick is an innovative cessation aid designed to directly address patients' hand/oral habit by substituting the cessation aid for cigarettes without integrating pharmacologic intervention, which is typically managed by their medical provider and may require direct supervision due to the patient's health status. The Buckeye Quit Stick is designed to satisfy the repeated hand/oral pattern or ritual, thereby avoiding the physical loss of holding a cigarette in the hand or mouth and the action of smoking. It may also help occupy fidgeting hands and potentially reduce stress and cravings. This novel cessation resource may address key factors that influence smoking abstinence and improve patients' health outcomes.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the feasibility and acceptability of the Buckeye Quit Stick among 30 patients seen in the Ohio State University (OSU) thoracic clinic(s) and to characterize frequency of use among the accrued sample.
EXPLORATORY OBJECTIVES:
- Characterizing the population. II. Determining communication preferences, acceptance of the Buckeye Quit Stick, abstinence estimates.
III. Assessing the quality of subjective measures (e.g., anxiety, quality of life, etc.).
IV. Gathering qualitative data to elicit participant feedback regarding the device, The James Comprehensive Cancer Center (CCC) smoking cessation clinic, and overall study design.
OUTLINE:
Patients receive a Buckeye Quit Stick and a smoking cessation informational packet on study. Patients also receive a referral to the James CCC smoking cessation clinic on study.
After completion of study intervention, patients are followed up at 2 weeks, 3 and 6 months, and then up to 24 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevention (Buckeye Quit Stick) | Experimental | Other: Electronic Health Record Review, Other: Informational Intervention, Other: Interview, Other: Referral, Device: Smoking Cessation Intervention, Other: Survey AdministrationPatients receive a Buckeye Quit Stick and a smoking cessation informational packet on study. Patients also receive a referral to the James CCC smoking cessation clinic on study. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- >= 21 years old
- Speak and understand English
- Established patient of the OSU thoracic clinics
- Diagnosed with a thoracic malignancy or has a clinically suspected thoracic malignancy as documented by treating provider
- Willing and able to participate in the study protocol (e.g., complete the survey and related study documents and provide informed consent)
Key exclusion criteria (4 listed)
- < 21 years old (Ohio is a tobacco 21 state.)
- Patient outside of the OSU clinics (This intervention targets patients who may benefit the most from cessation.)
- Unwilling or unable to provide consent or complete study components
- Prisoners will be excluded from participation
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 |
|---|---|---|
| Electronic Health Record ReviewAncillary studies | Other | Prevention (Buckeye Quit Stick) |
| Informational InterventionReceive smoking cessation information | Other | Prevention (Buckeye Quit Stick) |
| InterviewAncillary studies | Other | Prevention (Buckeye Quit Stick) |
| ReferralAlso: ReferredReceive referral | Other | Prevention (Buckeye Quit Stick) |
| Smoking Cessation InterventionAlso: Smoking and Tobacco Use Cessation InterventionsReceive Buckeye Quit Stick | Device | Prevention (Buckeye Quit Stick) |
| Survey AdministrationAncillary studies | Other | Prevention (Buckeye Quit Stick) |
Primary outcome
Recruitment rates (feasibility)
Time frame: Up to 1 year
To evaluate feasibility, recruitment rates will be defined as the proportion of screened adults accrued relative to those approached in the Ohio State University Comprehensive Cancer Center thoracic oncology clinic.
Adherence (feasibility)
Time frame: at baseline, 2 weeks, 3 months and 6 months
Adherence will be assessed by evaluating the proportion of retained participants at each timepoint who complete required study procedures and assessments at each timepoint
Retention rates (feasibility)
Time frame: At 2 weeks, 3 months, and 6 months
Retention rates will be defined as the percentage of participants not lost to follow-up at 2-weeks, 3-months and 6-months post-enrollment. Descriptive statistics will be performed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- The JameslineLink provided by the sponsor.
Related trials for Cigarette Smoking-Related Carcinoma
Not yet recruitingPhase 1
PK/PD of Vaping THC-containing Liquids vs. Smoked Cannabis
Cigarette Smoking-Related Carcinoma
RecruitingPhase 3
Reaching Rural Cancer Survivors Who Smoke Using Text-Based Program
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
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.
Logan Roof, MD, MS 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 Electronic Health Record Review, Informational Intervention and Interview in people with Cigarette Smoking-Related Carcinoma and Malignant Thoracic Neoplasm, 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 7 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Recruitment rates (feasibility) (time frame: Up to 1 year). The study lists 3 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 15 Sep 2026.