Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT01098955 |
| Other study ID # |
2009-0362 |
| Secondary ID |
NCI-2011-020041R |
| Status |
Active, not recruiting |
| Phase |
Early Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
March 24, 2010 |
| Est. completion date |
September 30, 2025 |
Study information
| Verified date |
May 2024 |
| Source |
M.D. Anderson Cancer Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
You will fill out 10 or 11 questionnaires that relate to:
- smoking
- 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.
The information you provide in the Tobacco Treatment Program (TTP) questionnaires regarding
anxiety, depression, alcohol use, sleeping difficulties, smoking withdrawal symptoms,
nicotine dependence and smoking will be used for this study, so that you do not have to fill
out these questionnaires twice. Physical data that you provided to the TTP (such as breath
samples, blood pressure, heart rate and weight) will also be used in this study, so that it
does not have to be collected twice.
Study Groups:
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.
You will be provided with a 10-week supply of varenicline. Your first dose will be at least 2
weeks before the quit date, and you will continue taking varenicline until 8 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.
Counseling Visits:
You will have 6 visits with a study counselor during the 12 weeks after your
screening/baseline visit.
At every visit:
- You will receive 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.
Videotaping:
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. Another
consultant is an assistant professor at University of Washington. All are collaborators for
this study and part of the research team.
Safety Procedures:
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).
Follow-Up Visit:
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 MD Anderson.
Part 2:
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 this 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:
- smoking
- 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.
The information you provide in the Tobacco Treatment Program (TTP) questionnaires regarding
anxiety, depression, alcohol use, sleeping difficulties, smoking withdrawal symptoms,
nicotine dependence and smoking will be used for this study, so that you do not have to fill
out these questionnaires twice. Physical data that you provided to the TTP (such as breath
samples, blood pressure, heart rate and weight) will also be used in this study, so that it
does not have to be collected twice. Some of the data you provide to this study regarding
mood, nicotine withdrawal, and smoking will be provided to the TTP so that it does not have
to be collected twice.
Study Groups:
You will be randomly assigned (as in the toss of a coin) to 1 of 2 groups. There is an equal
chance that you will be assigned to either group.
- 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.
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, if you so choose.
You will be provided with 10 weeks of medication. You will take it by mouth, up to 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.
Counseling Visits:
You will have 6 visits with a study counselor during the 12 weeks after your
screening/baseline visit.
At every visit:
- You will receive 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), the research staff may ask you to provide
a saliva sample that will be used to measure if and how much you have smoked.
Videotaping:
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, one consultant is a research scientist at the University of Texas, and the last
consultant is an assistant professor at University of Washington. All are collaborators for
this study and part of the research team.
Safety Procedures:
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).
Follow-Up Visits:
You will have follow-up visits at 3 and 6 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. At these visits, the research staff 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 second 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 MD Anderson.
