Ignite Creation Date:
2024-05-05 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 9:50 AM
Study NCT ID:
NCT00684437
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2008-05-22
Brief Title:
Literacy and Smoking Risk Communications
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Literacy and Smoking Risk Communications
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
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:
Objectives
Smokers with varying levels of health literacy as assessed by the S-TOFHLA ie inadequate marginal adequate recruited from the community will listen to one of 4 different types of messages emphasizing the health consequences of smoking recorded on a computer in the form of audio scripts ie a human voice pre-recorded on a computer will read each message Messages written at a 5th to 6th grade reading level will be concurrently presented in written form via a computer monitor and be manipulated in terms of 1 emotionality ie primarily fact- vs primarily emotion-based and 2 framing ie gain-framed messages that highlight the potential benefits of quitting smoking vs loss-framed messages that emphasize the potential costs of failing to quit smoking Emotionality and framing will be completely crossed to create four different types of messages 1 factual gain-framed FGF 2 factual loss-framed FLF 3 emotional gain-framed EGF and 4 emotional loss-framed ELF
The primary objectives are to
1 Examine whether main effects emerge for health literacy as assessed by the S-TOFHLA inadequate marginal adequate and the different message types fact- vs emotion-based and gain- vs loss-framed on the primary explicit and implicit outcomes a intention to quit and b implicit and explicit attitudes toward smoking
2 Examine whether health literacy interacts with the different types of messages fact-based vs emotion-based and gain-framed vs loss-framed to influence the primary explicit and implicit outcome measures a intention to quit smoking and b implicit and explicit attitudes toward smoking
A secondary exploratory aim is to
3 Examine potential associations between a the primary explicit and implicit outcomes and b the secondary explicit and implicit outcomes knowledge risk perception attitudes self-efficacy message evaluations implicit fear of disease and implicit associations between smoking and disease
Smokers with varying levels of health literacy as assessed by the S-TOFHLA ie inadequate marginal adequate recruited from the community will listen to one of 4 different types of messages emphasizing the health consequences of smoking recorded on a computer in the form of audio scripts ie a human voice pre-recorded on a computer will read each message Messages written at a 5th to 6th grade reading level will be concurrently presented in written form via a computer monitor and be manipulated in terms of 1 emotionality ie primarily fact- vs primarily emotion-based and 2 framing ie gain-framed messages that highlight the potential benefits of quitting smoking vs loss-framed messages that emphasize the potential costs of failing to quit smoking Emotionality and framing will be completely crossed to create four different types of messages 1 factual gain-framed FGF 2 factual loss-framed FLF 3 emotional gain-framed EGF and 4 emotional loss-framed ELF
The primary objectives are to
1 Examine whether main effects emerge for health literacy as assessed by the S-TOFHLA inadequate marginal adequate and the different message types fact- vs emotion-based and gain- vs loss-framed on the primary explicit and implicit outcomes a intention to quit and b implicit and explicit attitudes toward smoking
2 Examine whether health literacy interacts with the different types of messages fact-based vs emotion-based and gain-framed vs loss-framed to influence the primary explicit and implicit outcome measures a intention to quit smoking and b implicit and explicit attitudes toward smoking
A secondary exploratory aim is to
3 Examine potential associations between a the primary explicit and implicit outcomes and b the secondary explicit and implicit outcomes knowledge risk perception attitudes self-efficacy message evaluations implicit fear of disease and implicit associations between smoking and disease
Detailed Description:
Focus Groups
If you agree to take part in this study you will be asked to complete some questionnaires The questionnaires will ask about your age income level education level and smoking history This information will allow researchers to look at whether these factors affect how people understand smoking health risk information The questionnaires will take about 15 minutes to complete You will also complete a breath test To complete the breath test you 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 you inhale
You will participate in a focus group During the focus group research staff will be present to help discuss and evaluate various smoking risk informational messages You will be asked to decide which messages may be most influential in terms of helping smokers to quit smoking The messages will include information about health risks of smoking such as smoking-related cancers heart disease lung disease gum disease fertility problems and other related topics
The focus group session should last about 1 hour and 30 minutes
The messages will then be selected by the study doctor and used to create pamphlets on the risks of smoking These pamphlets will be used to help people quit smoking
Your participation on this study will be over once you have finished taking part in the focus group All focus groups will be audiotaped and the tape will be sent to an outside company to be transcribed No information that could be used to identify you such as your name or date of birth will be provided to the outside company
This is an investigational study Up to 30 smokers will participate in the focus groups All will be enrolled at M D Anderson
Pilot Testing and Main Study
Many people can get and understand smoking health risk information This study will look at which types of smoking risk information may be most easily understood by different people Participants in this study will be asked to listen to and read 1 of 4 types of messages on a computer These messages will talk about and list some health consequences of smoking
If you agree to take part in this study you will be asked to complete several questionnaires These questionnaires will ask about your feelings and moods thoughts about smoking risks of smoking smoking history and basic information such as your age education level and income level The questionnaires will take about 30 minutes to complete You will also complete a breath test To complete the breath test you 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 you inhale
After you have completed these questionnaires and the breath test you will complete several computer-aided tasks These computer-aided tasks will allow you to be able to read and hear informational messages about health risks of smoking such as smoking-related cancers heart disease lung disease gum disease fertility problems and other related topics During this study visit you will also evaluate several recently designed informational messages on the health risks of smoking The computer-aided tasks and the evaluation should last about 30 minutes
After evaluating these messages you will be asked to complete additional questionnaires in order for researchers to evaluate your responses to them These questionnaires will ask your opinion about the informational messages and the risks of smoking These last set of questionnaires should take about 30 minutes to complete Your participation will be over in this study once you complete the last set of questionnaires
This is an investigational study Up to 420 smokers will participate in this part of the study All will be enrolled at M D Anderson
If you agree to take part in this study you will be asked to complete some questionnaires The questionnaires will ask about your age income level education level and smoking history This information will allow researchers to look at whether these factors affect how people understand smoking health risk information The questionnaires will take about 15 minutes to complete You will also complete a breath test To complete the breath test you 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 you inhale
You will participate in a focus group During the focus group research staff will be present to help discuss and evaluate various smoking risk informational messages You will be asked to decide which messages may be most influential in terms of helping smokers to quit smoking The messages will include information about health risks of smoking such as smoking-related cancers heart disease lung disease gum disease fertility problems and other related topics
The focus group session should last about 1 hour and 30 minutes
The messages will then be selected by the study doctor and used to create pamphlets on the risks of smoking These pamphlets will be used to help people quit smoking
Your participation on this study will be over once you have finished taking part in the focus group All focus groups will be audiotaped and the tape will be sent to an outside company to be transcribed No information that could be used to identify you such as your name or date of birth will be provided to the outside company
This is an investigational study Up to 30 smokers will participate in the focus groups All will be enrolled at M D Anderson
Pilot Testing and Main Study
Many people can get and understand smoking health risk information This study will look at which types of smoking risk information may be most easily understood by different people Participants in this study will be asked to listen to and read 1 of 4 types of messages on a computer These messages will talk about and list some health consequences of smoking
If you agree to take part in this study you will be asked to complete several questionnaires These questionnaires will ask about your feelings and moods thoughts about smoking risks of smoking smoking history and basic information such as your age education level and income level The questionnaires will take about 30 minutes to complete You will also complete a breath test To complete the breath test you 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 you inhale
After you have completed these questionnaires and the breath test you will complete several computer-aided tasks These computer-aided tasks will allow you to be able to read and hear informational messages about health risks of smoking such as smoking-related cancers heart disease lung disease gum disease fertility problems and other related topics During this study visit you will also evaluate several recently designed informational messages on the health risks of smoking The computer-aided tasks and the evaluation should last about 30 minutes
After evaluating these messages you will be asked to complete additional questionnaires in order for researchers to evaluate your responses to them These questionnaires will ask your opinion about the informational messages and the risks of smoking These last set of questionnaires should take about 30 minutes to complete Your participation will be over in this study once you complete the last set of questionnaires
This is an investigational study Up to 420 smokers will participate in this part of the study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| 1R01CA125413-01 | NIH | None | None |
| NCI-2015-00727 | REGISTRY | NCI-CTRP Clinical Trials Registry | httpsreporternihgovquickSearch1R01CA125413-01 |