Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00384696
Status:
UNKNOWN
Last Update Posted:
2019-05-24
First Post:
2006-10-04
Brief Title:
Risk Perception Among Quitting Smokers
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Health Communications and Risk Processing Among Smokers
Status:
UNKNOWN
Status Verified Date:
2019-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this behavioral research study is to put together and study a treatment for nicotine dependence that looks at how participants thoughts and feelings about smoking may be related to how successfully they quit smoking
Detailed Description:
If patient agrees to participate they will receive free treatment to help them quit smoking including written self-help materials counseling and a supply of the nicotine patch for 4 weeks Participant will visit M D Anderson 5 times during this study once for an orientationintake visit and then for 4 more study visits
At the first orientation visit participant will be asked about their feelings and moods as well as their smoking status Participant will fill out questionnaires on a computer and complete a breath test The questionnaires will be about mood stress and smoking-related issues and should take about 1 hour and 30 minutes to complete To complete the breath test participant will blow into a tube thats attached to a machine about the size of a pocket computer The breath test is used to estimate the amount of tobacco smoke that participant inhales Participant will also complete two computer-based tasks Women who are pregnant should not take part in this study
In addition participant will receive a palmtop personal computer and be trained in how to use it Participant will carry this small computer with them from the time of their first visit until their last study visit Participant will use the computer to answer questions about their mood stress and smoking-related issues Participant will be asked to fill out some questions on the computer each time they have an urge to smoke or they actually smoke Also the computer will beep at random and set times and request that participant answers some questions
Participant will return for 4 visits after the orientation session During these visits participant will receive brief individual counseling where they will discuss techniques to help them quit smoking Participant will also be asked to fill out questionnaires on a computer about their moods and feelings as well as their smoking status The questionnaires should take about 30 minutes to complete The breath test will be given at every clinic visit
Participant may be contacted by mail telephone andor e-mail throughout the study and follow-up period to provide reminders of clinic visits Participant may also be asked for information about their smoking status during the usual reminder calls andor calls to reschedule missed appointments
A supply of the nicotine patch will be provided to participant at each counseling session The final supply of the patch is provided at the final counseling session
This is an investigational study The nicotine patch used in this study is approved by the Food and Drug Administration FDA About 20 people will take part in a pilot phase of this study then another 200 participants will take part in the main study All will be enrolled at M D Anderson
At the first orientation visit participant will be asked about their feelings and moods as well as their smoking status Participant will fill out questionnaires on a computer and complete a breath test The questionnaires will be about mood stress and smoking-related issues and should take about 1 hour and 30 minutes to complete To complete the breath test participant will blow into a tube thats attached to a machine about the size of a pocket computer The breath test is used to estimate the amount of tobacco smoke that participant inhales Participant will also complete two computer-based tasks Women who are pregnant should not take part in this study
In addition participant will receive a palmtop personal computer and be trained in how to use it Participant will carry this small computer with them from the time of their first visit until their last study visit Participant will use the computer to answer questions about their mood stress and smoking-related issues Participant will be asked to fill out some questions on the computer each time they have an urge to smoke or they actually smoke Also the computer will beep at random and set times and request that participant answers some questions
Participant will return for 4 visits after the orientation session During these visits participant will receive brief individual counseling where they will discuss techniques to help them quit smoking Participant will also be asked to fill out questionnaires on a computer about their moods and feelings as well as their smoking status The questionnaires should take about 30 minutes to complete The breath test will be given at every clinic visit
Participant may be contacted by mail telephone andor e-mail throughout the study and follow-up period to provide reminders of clinic visits Participant may also be asked for information about their smoking status during the usual reminder calls andor calls to reschedule missed appointments
A supply of the nicotine patch will be provided to participant at each counseling session The final supply of the patch is provided at the final counseling session
This is an investigational study The nicotine patch used in this study is approved by the Food and Drug Administration FDA About 20 people will take part in a pilot phase of this study then another 200 participants will take part in the main study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1 K01 CD000193-01 | OTHER | NCI | None |