494 Participants Needed

Health Literacy Interventions for Smoking

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you are not currently using nicotine replacement therapy or bupropion. If you are using these, you would need to stop before participating.

What data supports the effectiveness of this treatment for smoking cessation?

Research shows that low-literacy smokers often underestimate the risks of smoking and need tailored educational materials and counseling to quit effectively. Health literacy interventions, like using pictorial tools and verbal counseling, have been suggested to improve understanding and support smoking cessation, especially in populations with low literacy skills.12345

Is the health literacy intervention for smoking safe for humans?

The research articles do not provide specific safety data for health literacy interventions like focus groups, questionnaires, pictorial educational tools, or verbal counseling tools. These interventions are generally considered safe as they involve communication and education rather than medical procedures or medications.26789

How is the health literacy intervention for smoking different from other treatments?

This treatment focuses on improving health literacy (understanding health information) related to smoking, which is different from traditional methods that might focus on medication or behavioral therapy. By enhancing a person's ability to understand and use health information, it aims to empower individuals to make informed decisions about smoking cessation.110111213

What is the purpose of this trial?

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.

Research Team

Lorna H. McNeill | MD Anderson Cancer ...

Lorna McNeill

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for English-speaking smokers aged 18 to 70 who have smoked at least 5 cigarettes daily over the past year. They must have a home address, phone number, and not be using nicotine replacements or enrolled in cessation programs.

Inclusion Criteria

I currently smoke at least 5 cigarettes a day and have been doing so for the last year.
I have a home address and a working phone at home.
Can speak, read, and write in English

Exclusion Criteria

Current enrollment in a smoking cessation treatment program
Expired CO less than 10 ppm
I am currently using nicotine replacement therapy or bupropion.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Focus Group

Participants complete questionnaires and participate in a focus group to discuss and evaluate smoking risk informational messages

1.5 hours
1 visit (in-person)

Pilot Testing and Main Study

Participants complete questionnaires, a breath test, and computer-aided tasks to evaluate smoking risk messages

1.5 hours
1 visit (in-person)

Follow-up

Participants are monitored for understanding and response to smoking health risk informational messages

2 years

Treatment Details

Interventions

  • Focus Group
  • Questionnaire
Trial Overview The study tests how different types of messages about smoking risks affect smokers' intentions to quit and their attitudes towards smoking. It uses audio scripts with matching text that vary by emotionality (fact-based vs. emotional) and framing (benefits of quitting vs. costs of not quitting).
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Factual Loss-FramedExperimental Treatment2 Interventions
Smoking Risk Message - Factual Loss-Framed (FLF)
Group II: Factual Gain-FramedExperimental Treatment2 Interventions
Smoking Risk Message - Factual Gain-Framed (FGF)
Group III: Emotional Loss-FramedExperimental Treatment2 Interventions
Smoking Risk Message - Emotional Loss-Framed (ELF)
Group IV: Emotional Gain-FramedExperimental Treatment2 Interventions
Smoking Risk Message - Emotional Gain-Framed (EGF)

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

About half of American adults struggle with health literacy, which can lead to worse health outcomes and higher healthcare costs, highlighting the need for effective screening and support.
Implementing strategies like the teach-back method, visual aids, and patient empowerment training can significantly improve health literacy and patient self-management, ultimately enhancing health outcomes.
Practice improvement, part II: health literacy.Roett, MA., Coleman, MT.[2013]
A study involving 3,371 adult smokers found that pictorial warning labels on tobacco packaging elicited significantly stronger reactions compared to text-only warnings, enhancing salience, perceived impact, and credibility, as well as increasing intentions to quit smoking.
The effectiveness of pictorial warnings was consistent across various racial/ethnic and socioeconomic groups, suggesting that these labels could help reduce communication inequalities and may be an effective tobacco control policy, especially for vulnerable communities.
Impact of tobacco-related health warning labels across socioeconomic, race and ethnic groups: results from a randomized web-based experiment.Cantrell, J., Vallone, DM., Thrasher, JF., et al.[2023]
A systematic review identified 11 health literacy instruments, with some screening questions showing promise for effectively identifying patients with low health literacy through computer-based methods.
There is a need for more consistent screening questions and better psychometric data for these instruments, suggesting that a single reliable question could be sufficient for assessing health literacy in eHealth applications.
Health literacy screening instruments for eHealth applications: a systematic review.Collins, SA., Currie, LM., Bakken, S., et al.[2022]

References

Validity and reliability of the Smoking-related Health Literacy Assessment Scale. [2022]
Tobacco education in low-literacy individuals. [2017]
Practice improvement, part II: health literacy. [2013]
Asthma and COPD patients' perceived link between health literacy core domains and self-management of their condition. [2021]
Distribution of smoking relapse prevention materials in the Hispanic community: lessons learned. [2021]
Appalachian residents' perspectives on new U.S. cigarette warning labels. [2021]
Enhancing Smoking Risk Communications: The Influence of Health Literacy and Message Content. [2022]
Impact of tobacco-related health warning labels across socioeconomic, race and ethnic groups: results from a randomized web-based experiment. [2023]
The influence of health literacy and knowledge about smoking hazards on the intention to quit smoking and its intensity: an empirical study based on the data of China's health literacy investigation. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Health literacy in adolescents: an integrative review. [2022]
Media exposure, interactive health literacy, and adolescents' susceptibility to future smoking. [2017]
12.United Statespubmed.ncbi.nlm.nih.gov
Health literacy screening instruments for eHealth applications: a systematic review. [2022]
Bilingual health literacy assessment using the Talking Touchscreen/la Pantalla Parlanchina: Development and pilot testing. [2021]
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