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Recruiting NCT07455513

A Novel Tobacco Cessation Resource for Smokers With a Diagnosed or Suspected Thoracic Cancer

No phase Interventional Cigarette Smoking-Related Carcinoma Malignant Thoracic Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electronic Health Record Review, Informational Intervention, Interview, Referral.
Who it may be relevant to
Registry conditions: Cigarette Smoking-Related Carcinoma, Malignant Thoracic Neoplasm. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Pilot/Feasibility Study of the Buckeye Quit Stick: A Novel Resource for Successful Tobacco Cessation

Overview

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:

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.

Interventions

  • Other Electronic Health Record Review
    Ancillary studies
  • Other Informational Intervention
    Receive smoking cessation information
  • Other Interview
    Ancillary studies
  • Other Referral
    Receive referral
  • Device Smoking Cessation Intervention
    Receive Buckeye Quit Stick
  • Other Survey Administration
    Ancillary studies

Primary outcome measures

  • Recruitment rates (feasibility) [Time frame: Up to 1 year]
  • Adherence (feasibility) [Time frame: at baseline, 2 weeks, 3 months and 6 months]
  • Retention rates (feasibility) [Time frame: At 2 weeks, 3 months, and 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Ohio State University Comprehensive Cancer Center — Columbus

Identifiers

NCT: NCT07455513 · OSU-25129 · NCI-2026-00966

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗