Cigarette Smoking-Related Carcinoma, Malignant Thoracic Neoplasm
Conditions
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.
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
OTHERElectronic Health Record Review
Ancillary studies
OTHERInformational Intervention
Receive smoking cessation information
OTHERInterview
Ancillary studies
OTHERReferral
Receive referral
DEVICESmoking Cessation Intervention
Receive Buckeye Quit Stick
OTHERSurvey Administration
Ancillary studies
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rates (feasibility) | 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) | 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) | 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. |
Countries
United States
Contacts
CONTACTThe Ohio State University Comprehensive Cancer Center
PRINCIPAL_INVESTIGATORLogan Roof, MD, MS
Ohio State University Comprehensive Cancer Center
Outcome results
None listed