Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT00684437 |
| Other study ID # |
2006-0699 |
| Secondary ID |
1R01CA125413-01N |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 21, 2008 |
| Est. completion date |
May 31, 2024 |
Study information
| Verified date |
January 2024 |
| Source |
M.D. Anderson Cancer Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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:
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.
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.
