Health Literacy Interventions for Smoking

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Nicotine replacement, Bupropion

Disqualifiers: Smoking cessation program, CO<10 ppm

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different messages about smoking's health risks influence smokers' attitudes and intentions to quit. Participants will hear one of four message types that combine facts and emotions, emphasizing either the benefits of quitting or the costs of not quitting, to determine which is most effective. The trial targets smokers who have smoked at least 5 cigarettes a day for the past year and can communicate in English. The goal is to understand how these messages affect smokers' thoughts and feelings about quitting, potentially aiding in the development of more impactful anti-smoking campaigns. As an unphased trial, it offers participants the chance to contribute to research that could shape more effective anti-smoking strategies.

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 prior data suggests that these health literacy interventions are safe for participants?

Research shows that the treatments in this trial—different types of messages about smoking—are very safe. Previous studies have found that using factual and emotional messages about the risks of smoking does not cause any health problems. These messages are audio recordings and written text designed to influence thoughts and attitudes about quitting smoking.

The trial examines four types of messages: factual positive, factual negative, emotional positive, and emotional negative. These are not medications or physical treatments, so there are no side effects to worry about. The goal is to understand how different message styles affect smokers' intentions to quit and their views on smoking.

Participating in this kind of messaging study is generally very safe. Participants simply listen to or read messages, with no risk of physical harm from these communications. Therefore, safety should not be a concern for those considering joining this study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different ways of framing health messages can impact smoking behavior. Unlike traditional smoking cessation programs that often focus on behavioral therapy or pharmacological aids, this trial examines four unique messaging strategies: factual loss-framed, emotional loss-framed, factual gain-framed, and emotional gain-framed. These strategies aim to tap into the psychological aspects of decision-making by presenting information about smoking risks in varied emotional and factual contexts. The hope is to uncover which type of message is most effective at encouraging smokers to quit, potentially leading to more personalized and effective public health campaigns.

What evidence suggests that this trial's interventions could be effective for smoking cessation?

This trial will compare different types of smoking risk messages. Research has shown that the method used to encourage smokers to quit can make a difference. Participants in this trial will receive either factual or emotional messages. Factual messages, particularly for those who understand health information well, can increase awareness of risks and boost confidence in quitting. Emotional messages, however, can be more effective overall, especially when focusing on the negative effects of smoking. This trial will test both loss-framed messages, which highlight potential losses from continuing to smoke, and gain-framed messages, which emphasize the benefits of quitting. Studies suggest that loss-framed messages can be more convincing, but gain-framed messages can also be effective, particularly in helping individuals achieve early success in quitting. Overall, the impact of these messages can vary based on an individual's understanding of health information and their perception of risk. ^{3 5 6 7 8}

Who Is on the Research Team?

Lorna McNeill

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

Group I: Factual Loss-Framed Experimental Treatment 2 Interventions

Smoking Risk Message - Factual Loss-Framed (FLF)

Group II: Factual Gain-Framed Experimental Treatment 2 Interventions

Smoking Risk Message - Factual Gain-Framed (FGF)

Group III: Emotional Loss-Framed Experimental Treatment 2 Interventions

Smoking Risk Message - Emotional Loss-Framed (ELF)

Group IV: Emotional Gain-Framed Experimental Treatment 2 Interventions

Smoking Risk Message - Emotional Gain-Framed (EGF)

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health literacy screening instruments for eHealth applications: a systematic review. Collins, SA., Currie, LM., Bakken, S., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice improvement, part II: health literacy. Roett, MA., Coleman, MT.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5942894/

Enhancing Smoking Risk Communications: The Influence of ... Among smokers with higher health literacy, factual messages produced higher perceived risk and stronger expectations for quitting. Among smokers ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2527723/

Message framing for smoking cessation: The interaction of ... Participants who anticipated high risks associated with quitting smoking reported fewer days to relapse. Further, females in the gain-framed condition who ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00684437

Study Details | NCT00684437 | Literacy and Smoking Risk ... 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 ...

4. journals.lww.com journals.lww.com/mhhb/fulltext/2023/28020/comparative_evaluation_of_the_effect_of_loss__and.3.aspx

Comparative Evaluation of the Effect of Loss- and Gain- ... The current systematic review aimed to compare the available literature on the effect of loss- and gain-framed tobacco cessation messages on smoking behavior.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1054139X2400404X

Effects of Message Frames and Sources in TikTok Videos ... Our findings highlight the effectiveness of using gain-framed videos to promote youth vaping cessation by eliciting positive emotions. Our findings align with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2527727/

Comparing Gain- and Loss-Framed Messages for Smoking ... Prospect theory suggests that because smoking cessation is a prevention behavior with a fairly certain outcome, gain-framed messages will be more persuasive ...

7. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT00684437

NCT00684437 | Literacy and Smoking Risk Communications 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 ...

8. bpspsychub.onlinelibrary.wiley.com bpspsychub.onlinelibrary.wiley.com/doi/full/10.1111/bjhp.70025

Investigating attitudes and framing moral responsibility in ... Prescribing prevalence, effectiveness, and mental health safety of smoking cessation medicines in patients with mental disorders. Nicotine ...