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The goal of Part 1 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.
This part of the study is also designed to train the study counselors how to perform Acceptance and Commitment Therapy.
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).
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.
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.
Signing this consent form does not mean that you will be able to take part in this study. You will have "screening tests" to help the researcher decide if you are eligible to take part in this study. The following tests and procedures will be performed:
- You will be asked about your smoking habits and about any treatments you are currently receiving to help you stop smoking.
- You will be asked about any current problems with depressed mood, anxiety, drug and alcohol use, and other mental health problems.
- You will meet with a study counselor. During the meeting, you will discuss your experiences with cancer and cancer treatment. The counselor will also ask you about your relationships with others, and about parts of your life that may be stressful. This interview will take about an hour.
The researcher will discuss the screening test results with you. If the screening tests show that you are not eligible to take part in the study, you will not be enrolled. Other treatment options will be discussed with you.
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.
You will fill out 10 or 11 questionnaires that relate to:
- any symptoms of nicotine dependence and withdrawal
- your feelings and thoughts in response to urges to smoke
- your confidence in your ability to quit smoking
- your reasons for quitting smoking
- your mood
- your use of alcohol
- the general quality of your life
- any effects of cancer on your ability to take part in everyday activities
- your response to stressful events in your life
Saliva will be collected to check for a chemical called cotinine. This test will help researchers measure how much you are smoking. To collect saliva, a cotton swab will be placed in your mouth for several minutes.
You will be assigned to 1 of 2 groups. The group you are in will be decided based on the study counselors' training schedules and other study needs.
- Group 1 will receive Acceptance and Commitment Therapy.
- Group 2 will receive Motivational and Behavioral Counseling.
You will receive a booklet that describes the type of counseling you will receive.
Varenicline as Standard Care:
Participants in both groups will receive varenicline through the Tobacco Treatment Program. Varenicline is designed to imitate the effects that nicotine has on the body. This may reduce cigarette cravings and help people quit smoking.
As part of your counseling sessions, you will be counseled to help you make a plan to quit smoking and to set a quit date. The quit date may be scheduled for about 3 weeks after your screening/baseline visit.
Your first dose of varenicline will be 1 week before the quit date, and you will continue taking varenicline until 12 weeks after the quit date. You will take it by mouth, 2 times a day.
- Varenicline is the standard drug that is given in the Tobacco Treatment Program.
- The Tobacco Treatment Program staff will discuss the risks of varenicline with you.
You will have 6 visits with a study counselor during the 6 weeks after your screening/baseline visit.
At every visit:
- You will receiving counseling that will last about an hour.
- You will fill out 5-8 questionnaires about smoking, mood, alcohol use, quality of life, and coping. This should take about 20-30 minutes.
- You will be asked about any changes in the drugs or other treatments you may be receiving.
- You will be asked about how you took varenicline.
- You will be given homework assignments that will help you practice the skills that you learn during the visits. There will be 1 or 2 homework assignments per week, and each assignment will take about 30 minutes.
At your last counseling visit (Counseling Visit 6), you will be asked questions about how satisfied you may be with the study counseling. Also at this visit, the research staff may ask you to provide a saliva sample that will be used to measure if and how much you have smoked.
If you do not complete all 6 of the counseling sessions, the research staff will call and ask you what made it difficult for you to complete the counseling sessions.
Each of the counseling visits will be videotaped. The videotapes will be used to help the research staff make sure that the study counselors are following the correct therapy procedures.
The videotapes will probably be saved for 2 years and then destroyed. However, it is possible that these videotapes will be saved for a longer period of time.
Only the research staff, study counselors, and study consultants will be allowed to watch the tapes. The study consultants will review the tapes and rate how well the study counselors follow therapy procedures. One consultant is an associate professor at the University of Mississippi. The other consultant is a research scientist at the University of Texas. Both are collaborators for this study and part of the research team.
Quitting smoking may cause side effects affecting your mental and emotional health. For your safety, the study counselor and study chair will be looking for any signs that you may be having these side effects.
If the study counselor or study chair think that you may be having emotional difficulties or depression, they may decide to recommend that you be treated for it.
If they believe you are at risk of being a danger to yourself, you will be contacted by the study chair right away and if appropriate, you will be referred to meet with the Tobacco Treatment Program psychiatrist (mental health doctor).
You will have a follow-up visit at 3 months after your quit date. You will complete most of the same questionnaires that you completed at the screening/baseline visit, and this should take about 30 minutes. The research staff also may ask you to provide a saliva sample that will be used to measure if and how much you have smoked.
Length of Study:
Your participation in this study will be over after your follow-up visit.
This is an investigational study. Acceptance and Commitment Therapy is investigational, and Motivational and Behavioral Counseling is standard.
Varenicline is FDA approved and commercially available to help people stop smoking.
Up to 108 patients will take part in this study. This includes 12 participants who are interviewed before Part 1 opens, 20 participants in Part 1, and 76 participants in Part 2. All will be enrolled at M. D. Anderson.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Head and Neck Cancer
Acceptance and Commitment Therapy, Motivational and Behavioral Counseling, Varenicline
UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
Published on BioPortfolio: 2014-08-27T03:14:46-0400
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