A Pilot/Feasibility Study of the Buckeye Quit Stick: A Novel Resource for Successful Tobacco Cessation
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Recruitment rates (feasibility)
研究概览
简要总结
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.
详细描述
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.).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>= 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
排除标准
- •< 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
研究组 & 干预措施
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.
干预措施: Electronic Health Record Review (Other)
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.
干预措施: Survey Administration (Other)
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.
干预措施: Informational Intervention (Other)
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.
干预措施: Referral (Other)
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.
干预措施: Interview (Other)
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.
干预措施: Smoking Cessation Intervention (Device)
结局指标
主要结局
Recruitment rates (feasibility)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点
研究者
Logan Roof
Principal Investigator
Ohio State University Comprehensive Cancer Center
