- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07455513
A Novel Tobacco Cessation Resource for Smokers With a Diagnosed or Suspected Thoracic Cancer
A Pilot/Feasibility Study of the Buckeye Quit Stick: A Novel Resource for Successful Tobacco Cessation
Study Overview
Status
Detailed Description
PRIMARY OBJECTIVE:
I. 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:
I. 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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: The Ohio State University Comprehensive Cancer Center
- Phone Number: 800-293-5066
- Email: OSUCCCClinicaltrials@osumc.edu
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Recruiting
- Ohio State University Comprehensive Cancer Center
-
Contact:
- Logan Roof, MD, MS
- Phone Number: 614-293-6786
- Email: Logan.Roof@osumc.edu
-
Principal Investigator:
- Logan Roof, MD, MS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- >= 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
Exclusion Criteria:
- < 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Prevention (Buckeye Quit Stick)
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.
|
Ancillary studies
Ancillary studies
Ancillary studies
Receive referral
Other Names:
Receive smoking cessation information
Receive Buckeye Quit Stick
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Up to 1 year
|
|
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
|
at baseline, 2 weeks, 3 months and 6 months
|
|
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.
|
At 2 weeks, 3 months, and 6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Logan Roof, MD, MS, Ohio State University Comprehensive Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Professional Practice
- Organization and Administration
- Health Services Administration
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Interviews as Topic
- Referral and Consultation
Other Study ID Numbers
- OSU-25129
- NCI-2026-00966 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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