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Tobacco-Related CarcinomaNCT06644664

Nicotine and Tobacco Message Framing to Change Smoking Behavior in Diverse Groups of Young Adult Smokers

A study testing Health Education, Interview and Smoking Cessation Intervention in people with Tobacco-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This clinical trial evaluates the effect of message framing on smoking behaviors among lesbian, gay, bisexual, transgender, queer (LGBTQ+) young adults who use nicotine and/or tobacco. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Tobacco-Related Carcinoma
What is being tested?
Health Education, Interview and Smoking Cessation Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
292 participants
Where
1 siteUnited States
Study dates
24 Sep 2024to 2 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

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 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 18-35 years old
  • Self-identify as LGBTQ+
  • Able to speak English fluently
  • An ever user of ENDS and combustible tobacco who currently use ENDS, combustible cigarettes, or both ENDS and combustible cigarettes
  • Currently reside in the United States (US)
  • Have a mobile phone through a U.S. carrier with MMS messaging and can send and receive text messages for study participation
  • Access to the internet with Zoom capabilities

Who cannot join

  • Have a landline or Voice Over Internet Protocol (VOIP) phone number

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: The Effect of Nicotine and Tobacco Message Framing on Use Among Diverse Groups of Young Adults: Aim 3 Randomized Control Trial (RCT)

This clinical trial evaluates the effect of message framing on smoking behaviors among lesbian, gay, bisexual, transgender, queer (LGBTQ+) young adults who use nicotine and/or tobacco. Tobacco regulation has contributed to a steady decline in tobacco products designed to be smoked (combustible), but there has been an increase in the use of new tobacco products, such as electronic nicotine delivery systems (ENDS). The use of more than one tobacco product (polytobacco) is high in LGBTQ+ populations. Both LGBTQ+ people and people who engage in polytobacco use are less likely to view tobacco as harmful, which may reinforce tobacco use. Message framing includes culturally targeted messages to communicate the absolute risks (AR) and relative risks (RR) of polytobacco use. Using message framing may increase quit rates or change smoking behaviors in LGBTQ+ young adults who use nicotine and/or tobacco products.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Assess the feasibility of delivering mobile multimedia messaging (MMS) anti-tobacco messages developed in the K99 to LGBT young adults via texting.

II. Estimate effect sizes of exposure to anti-tobacco messages on risk perceptions and tobacco use over time.

OUTLINE: Participants are randomized to 1 of 3 arms.

ARM I: Participants receive AR anti-polytobacco MMS messages 3 times a week (TIW) and a check-in text message once a week (QW) for a total of 6 weeks.

ARM II: Participants receive RR anti-polytobacco MMS messages TIW and a check-in text message QW for a total of 6 weeks.

ARM III: Participants receive control MMS messages on health risks of ultraviolet (UV)/sun exposure TIW and a check-in text message QW for a total of 6 weeks.

All participants also receive smoking cessation resources via email during follow up.

After completion of study intervention, participants are followed up at 6 and 12 weeks.

Being tested
Health Education, Interview, Smoking Cessation Intervention, Survey Administration, Text Message-Based Navigation Intervention
Keywords
Sexual and Gender Minorities, Health Communication, Tobacco Products, Cigarettes, Electronic Nicotine Delivery Systems, E-cigarettes, young adult, text messaging
Medical subject headings
Coitus, Vaping

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health EducationBehavioural

    Receive control MMS messages

  • InterviewOther

    Ancillary studies

  • Smoking Cessation InterventionBehavioural

    Also called Smoking and Tobacco Use Cessation Interventions

    Receive AR MMS messages

  • Smoking Cessation InterventionBehavioural

    Also called Smoking and Tobacco Use Cessation Interventions

    Receive RR MMS messages

  • Smoking Cessation InterventionBehavioural

    Also called Smoking and Tobacco Use Cessation Interventions

    Receive smoking cessation resources

  • Survey AdministrationOther

    Ancillary studies

  • Text Message-Based Navigation InterventionOther

    Also called Automated Text Message-Based Navigation, Text Message-Based Navigation

    Receive check-in text message

Study groups in NCT06644664
Study groupRoleWhat they receive
Arm I (Absolute Risk messages)ExperimentalParticipants receive AR anti-polytobacco MMS messages TIW and a check-in text message QW for a total of 6 weeks. Participants also receive smoking cessation resources via email during follow up.
Receives: Other: Interview; Behavioral: Smoking Cessation Intervention; Other: Survey Administration; Other: Text Message-Based Navigation Intervention
Arm II (Relative Risk messages)ExperimentalParticipants receive RR anti-polytobacco MMS messages TIW and a check-in text message QW for a total of 6 weeks. Participants also receive smoking cessation resources via email during follow up.
Receives: Other: Interview; Behavioral: Smoking Cessation Intervention; Other: Survey Administration; Other: Text Message-Based Navigation Intervention
Arm III (control messages)Active comparatorParticipants receive control MMS messages on health risks of UV/sun exposure TIW and a check-in text message QW for a total of 6 weeks. Participants also receive smoking cessation resources via email during follow up.
Receives: Behavioral: Health Education; Behavioral: Smoking Cessation Intervention; Other: Survey Administration; Other: Text Message-Based Navigation Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total tobacco cessation

    2 items. Asks for current use of nicotine vapes and combustible cigarettes Every day, Some days, or Not at all.

    Measured: At 12 weeks post-baseline

  2. Acceptability of multimedia messaging service (MMS) anti-polytobacco messages

    In a qualitative interview, Participants will be asked the following question: How did you find participating in a study with images sent via text message? How smoothly would you say it went?

    Measured: At 6-week post-enrollment

  3. Feasibility of MMS anti-polytobacco messages

    6 items per study arm. Experimental arms 1 and 2: 6 Yes/No questions (1 per week) checking for engagement with the study content, specifically regarding nicotine and tobacco use. Control Group: 6 Yes/No questions (1 per week) checking for engagement with the study content, specifically regarding sun safety.

    Measured: At 6-weeks post-enrollment

Secondary outcomes (4)

  1. Switching to exclusive electronic nicotine delivery system (ENDS) use

    2 items. Asks for current use of nicotine vapes and combustible cigarettes Every day, Some days, or Not at all.

    Measured: At 6- and 12-weeks post-baseline

  2. Risk perceptions

    3 items. 2 items on a 5 point likert scale where 1= Not at all harmful and 5= Extremely harmful. How harmful do you think nicotine vapes, e-cigarettes, or other electronic products are to health? How harmful do you think cigarettes are to health?; 1 item with 3 response options: Less harmful, About the same, More harmful. Is using nicotine vapes, e-cigarettes or other electronic nicotine products less harmful, about the same, or more harmful than smoking cigarettes?

    Measured: At 6- and 12-weeks post-baseline

  3. Behavioral intentions

    2 Items. Are you seriously thinking of quitting nicotine vapes? and Are you seriously thinking of quitting cigarettes? 5 response options: Yes, within the next 30 days; Yes, within the next 6 months; Yes, within the next year; Yes, but not within the next year; No, not thinking of quitting.

    Measured: Difference between conditions in behavioral intentions from screener, and at 6 and 12-week post baseline

  4. Serious quit attempts

    2 items. During the PAST 12 MONTHS, how many times have you stopped vaping nicotine for 1 day or longer because you were trying to quit? and During the PAST 12 MONTHS, how many times have you stopped vaping nicotine for 1 day or longer because you were trying to quit? 5 response options: None; 1-2 times; 3-5 times; 6-10 times; More than 10 times

    Measured: Difference between conditions in quit attempts from screener, and at 6 and 12-week post baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2024
  2. Study start24 Sep 2024
  3. Primary completion2 Feb 2026
  4. Study completion2 Feb 2026

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
292 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06644664
Sponsor's protocol ID
OSU-23436
Other IDs
NCI-2024-04955, R00CA260718
Status last verified
Mar 2026
First submitted
15 Oct 2024
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Health Education, Interview and Smoking Cessation Intervention in people with Tobacco-Related Carcinoma, run by Ohio State University Comprehensive 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 7 inclusion and 1 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: finished, as of the sponsor's last update on 30 Mar 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Total tobacco cessation (time frame: At 12 weeks post-baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06644664.

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 30 Mar 2026.

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