SmokingNCT00684437
Literacy and Smoking Risk Communications
A study testing Focus Group and Questionnaire in people with Smoking, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Objectives: Smokers with varying levels of health literacy as assessed by the S-TOFHLA (i.e., 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 (i.e., a… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Focus Group and Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 494 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2008to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 to 70 years
- current smoker with a history of at least 5 cigarettes/day for the last year
- can speak, read, and write in English
- home address and a functioning home telephone number
Who cannot join
- current use of nicotine replacement therapy or bupropion
- current enrollment in a smoking cessation treatment program
- expired CO<10 ppm
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Objectives:
Smokers with varying levels of health literacy as assessed by the S-TOFHLA (i.e., 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 (i.e., 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 (i.e., primarily fact- vs. primarily emotion-based), and 2) framing (i.e., 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).
Read more
The primary objectives are to:
- 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.
- 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:
- 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.
Read the 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 that's 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 that's 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.
- Conditions
- Smoking
- Being tested
- Focus Group, Questionnaire
- Keywords
- Health Literacy, Smoking Risk, Focus Group, Questionnaire, Survey
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus GroupBehavioural
Focus group discussion and evaluation of various smoking risk informational messages. The focus group session should last about 1 hour and 30 minutes.
QuestionnaireBehavioural
Also called Survey
Questionnaires taking 15-30 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Factual Gain-Framed | Experimental | Smoking Risk Message - Factual Gain-Framed (FGF) Receives: Behavioral: Focus Group; Behavioral: Questionnaire |
| Factual Loss-Framed | Experimental | Smoking Risk Message - Factual Loss-Framed (FLF) Receives: Behavioral: Focus Group; Behavioral: Questionnaire |
| Emotional Gain-Framed | Experimental | Smoking Risk Message - Emotional Gain-Framed (EGF) Receives: Behavioral: Focus Group; Behavioral: Questionnaire |
| Emotional Loss-Framed | Experimental | Smoking Risk Message - Emotional Loss-Framed (ELF) Receives: Behavioral: Focus Group; Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors that may influence how smokers understand smoking health risk informational messages.
Examine whether main effects emerge for health literacy as assessed by the Short Test of Functional Health Literacy in Adults (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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study start21 May 2008
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lorna H. McNeill, MPH,PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684437
- Sponsor's protocol ID
- 2006-0699
- Other IDs
- 1R01CA125413-01, NCI-2015-00727
- Status last verified
- Jul 2026
- First submitted
- 22 May 2008
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Literacy and Smoking Risk Communications
- ClinicalTrials.gov ID
- NCT00684437
- Acronym / sponsor ID
- 2006-0699
- Conditions
- Smoking
- Keywords
- Health Literacy, Smoking Risk, Focus Group, Questionnaire, Survey
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 494 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 May 2008 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 26 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
Smokers with varying levels of health literacy as assessed by the S-TOFHLA (i.e., 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 (i.e., 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 (i.e., primarily fact- vs. primarily emotion-based), and 2) framing (i.e., 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:
- 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.
- 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:
- 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 that's 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 that's 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Factual Gain-Framed | Experimental | Behavioral: Focus Group, Behavioral: QuestionnaireSmoking Risk Message - Factual Gain-Framed (FGF) |
| Factual Loss-Framed | Experimental | Behavioral: Focus Group, Behavioral: QuestionnaireSmoking Risk Message - Factual Loss-Framed (FLF) |
| Emotional Gain-Framed | Experimental | Behavioral: Focus Group, Behavioral: QuestionnaireSmoking Risk Message - Emotional Gain-Framed (EGF) |
| Emotional Loss-Framed | Experimental | Behavioral: Focus Group, Behavioral: QuestionnaireSmoking Risk Message - Emotional Loss-Framed (ELF) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 to 70 years
- current smoker with a history of at least 5 cigarettes/day for the last year
- can speak, read, and write in English
- home address and a functioning home telephone number
Key exclusion criteria (3 listed)
- current use of nicotine replacement therapy or bupropion
- current enrollment in a smoking cessation treatment program
- expired CO<10 ppm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus GroupFocus group discussion and evaluation of various smoking risk informational messages. The focus group session should last about 1 hour and 30 minutes. | Behavioural | Emotional Gain-Framed, Emotional Loss-Framed, Factual Gain-Framed, Factual Loss-Framed |
| QuestionnaireAlso: SurveyQuestionnaires taking 15-30 minutes to complete. | Behavioural | Emotional Gain-Framed, Emotional Loss-Framed, Factual Gain-Framed, Factual Loss-Framed |
Primary outcome
Factors that may influence how smokers understand smoking health risk informational messages.
Time frame: 2 years
Examine whether main effects emerge for health literacy as assessed by the Short Test of Functional Health Literacy in Adults (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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorna H. McNeill, MPH,PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focus Group and Questionnaire in people with Smoking, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factors that may influence how smokers understand smoking health risk informational messages. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.