Smoking Cessation Treatment for Head & Neck Cancer Patients: Acceptance and Commitment Therapy
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Smoking Abstinence Rate
研究概览
简要总结
This is Part 1 of a 2-part research study. The goal of this part of the study is to plan and test an investigational type of counseling called Acceptance and Commitment Therapy, for use in patients who have or had head and neck cancer, lung cancer, breast cancer, gastrointestinal cancer, or genitourinary cancer.
This part of the study is also designed to train the study counselors how to perform Acceptance and Commitment Therapy.
In this part of the study, participants will either receive Acceptance and Commitment Therapy or the standard type of counseling, called Motivational and Behavioral Counseling.
This is Part 2 of a 2-part research study. In both parts of the study, participants receive either an investigational type of counseling (Acceptance and Commitment Therapy) or a standard type of counseling (Motivational and Behavioral Counseling). Part 1 was also designed to train the study counselors how to perform Acceptance and Commitment Therapy.
The goal of Part 2 is to compare Acceptance and Commitment Therapy against Motivational and Behavioral Counseling. Researchers want to learn which type of counseling may be more effective in helping patients to stop smoking. These types of counseling will be tested in patients who have or had head and neck cancer, lung cancer, breast cancer, gastrointestinal cancer, or genitourinary cancer.
详细描述
Part 1:
Counseling to Quit Smoking Acceptance and Commitment Therapy is designed to help patients change the way they respond to feelings and thoughts that cause them to want to smoke. It is also designed to help increase patients' ability to tolerate negative feelings about cancer, and to increase patients' commitment to other goals that are related to what they value in life.
Motivational and Behavioral Counseling is designed to help patients increase their motivation to quit smoking. It is also designed to help patients develop skills and behaviors that will help them cope with situations when they want to smoke.
Baseline Tests:
If you are found to be eligible to take part in the pilot study, you will have additional "baseline" tests. This will include a series of questionnaires, which will take about 30 minutes to complete, and a saliva test. These tests will be done at the same visit as the screening tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Current or history of head and neck, lung, breast, gastrointestinal, or genitourinary cancer
- •Age 18 or older
- •Smoking 1 cigarette or more per day at screening visit
- •English speaking and have a telephone
- •Willing to provide informed consent and agree to all assessments and study procedures
- •Recommended for and agreed to treatment with varenicline through the Tobacco Treatment Program
- •Plan to receive treatment for head and neck, lung, breast, gastrointestinal, or genitourinary cancer, currently undergoing treatment, or in follow-up care at M.D. Anderson Cancer Center
排除标准
- •Anticipated hospitalization of 2 weeks or longer
- •Planned total laryngectomy
- •Current use of bupropion, nortriptyline, clonidine or nicotine replacement therapy
- •Currently receiving other forms of smoking cessation treatment
- •Severe levels of depressive symptoms, vegetative symptoms, and/or symptoms related to psychiatric disorders that place participant at risk for harm or require immediate treatment
- •Currently pregnant or lactating
- •Has received treatment in the TTP
- •History or/current medical condition, or any other factor that , in the judgment of the PI would likely preclude completion of study requirements
研究组 & 干预措施
ACT Group 1
Acceptance and Commitment Therapy (ACT). Varenicline 2 mg daily for 12 weeks.
干预措施: Varenicline (Drug)
MBC Group 2
Motivational and Behavioral Counseling (MBC). Varenicline 2 mg daily for 12 weeks.
干预措施: Varenicline (Drug)
MBC Group 2
Motivational and Behavioral Counseling (MBC). Varenicline 2 mg daily for 12 weeks.
干预措施: Motivational and Behavioral Counseling (Behavioral)
ACT Group 1
Acceptance and Commitment Therapy (ACT). Varenicline 2 mg daily for 12 weeks.
干预措施: Acceptance and Commitment Therapy (Behavioral)
结局指标
主要结局
Smoking Abstinence Rate
时间窗: Baseline up to 6 weeks
Participants will be assessed on a variety of interview, self-report, and biochemical measures at baseline, at key points during treatment (including end of treatment), and at 14-, and 26-weeks after the targeted quit date
次要结局
未报告次要终点