Pilot Study of the Effectiveness of the JeffQuit Smoking Cessation Program
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Proportion of patients who are adherent to smoking abstinence
研究概览
简要总结
This pilot clinical trial studies how well the "JeffQuit" group therapy program works in enabling patients with a history of cancer to quit smoking. The JeffQuit program uses group therapy to provide psychological support and address the mental need for smoking, the habit or routine it creates, and the physical need for nicotine. It is not yet known how well the JeffQuit program will work in helping patients with a history of cancer to stop smoking.
详细描述
PRIMARY OBJECTIVES:
I. To assess the initial effectiveness of the JeffQuit program on smoking cessation in cancer patients.
II. To assess the quality of life improvements related to the JeffQuit smoking cessation program in cancer patients.
OUTLINE:
Patients undergo three, 1-hour group therapy sessions held by a JeffQuit practitioner over a 1-month period. Patients receive strategies for managing the psychological, habitual, and physiological components of smoking and help with developing a planned quit date. Patients are also provided with advice on how to switch to cigarette brands with less nicotine and then how to substitute the nicotine patch and gum for cigarettes. The JeffQuit counselor is available for additional individual support as needed.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of cancer
- •Current smoker
- •Willing to provide consent and participate in the JeffQuit program
- •Referral by a Kimmel Cancer Center provider
排除标准
- •Any significant active medical disorder or physical condition that could reasonably be expected to interfere with the ability of the patient to quit smoking as determined by the Principal Investigator (PI)
- •Currently participating in another smoking cessation program
- •Currently receiving chemotherapy or radiation therapy that would interfere with their ability to participate in the JeffQuit program
- •Patients with evidence of a significant psychiatric disorder by history/examination that would prevent completion of the study will not be allowed to participate
- •Patients with current alcohol or drug abuse
- •Enrollment in active clinical trial/ experimental therapy within the prior 30 days
- •Are in the terminal stages of illness
结局指标
主要结局
Proportion of patients who are adherent to smoking abstinence
时间窗: Up to 6 months after completion of intervention
Calculated along with a 1-sided 95% exact confidence interval. An exact binomial test (with a one-sided alpha of 0.05) will also be used to test whether adherence is greater than 60%.
次要结局
- Change in Smoking Cessation Quality of Life (SCQoL) questionnaire scores(Baseline to up to 6 months after completion of intervention)
- Change in Patient Reported Outcomes Measurement Information System (PROMIS) quality of life scores(Baseline to up to 6 months after completion of intervention)