NCT07455513

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
May 2026Dec 2026

First Submitted

Initial submission to the registry

February 24, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

February 24, 2026

Last Update Submit

March 2, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    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.

    At 2 weeks, 3 months, and 6 months

Study Arms (1)

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.

Other: Electronic Health Record ReviewOther: Informational InterventionOther: InterviewOther: ReferralDevice: Smoking Cessation InterventionOther: Survey Administration

Interventions

Ancillary studies

Prevention (Buckeye Quit Stick)

Receive smoking cessation information

Prevention (Buckeye Quit Stick)

Ancillary studies

Prevention (Buckeye Quit Stick)

Receive referral

Also known as: Referred
Prevention (Buckeye Quit Stick)

Receive Buckeye Quit Stick

Also known as: Smoking and Tobacco Use Cessation Interventions
Prevention (Buckeye Quit Stick)

Ancillary studies

Prevention (Buckeye Quit Stick)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>= 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

You may not qualify if:

  • \< 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

MeSH Terms

Interventions

Interviews as TopicReferral and Consultation

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthProfessional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Logan Roof, MD, MS

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 24, 2026

First Posted

March 6, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 6, 2026

Record last verified: 2026-03

Locations