Tobacco-Related CarcinomaNCT05393869

Evaluating Anti-Tobacco Message Effectiveness Among Lesbian, Gay, Bisexual, and Transgender Young Adults

A study testing Health communications 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

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 communications
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,849 participants
Where: 1 siteUnited States
Study dates: 14 Apr 2021to 14 Nov 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Young adults (age 18-35 years)
Live in the United States
At least 50% of the sample also:
Are susceptible to multiple nicotine and tobacco product use (i.e., have used combustible tobacco or e-cigarettes at least once)

Who cannot join

None listed.

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

This trial refines and evaluates anti-tobacco messages among lesbian, gay, bisexual, and transgender (LGBT) young adults at risk for the use of more than one tobacco product (polytobacco use). Polytobacco use is associated with nicotine dependence and tobacco use into adulthood, and is disproportionately high among LGBT young adults. This trial seeks to determine effective communication of polytobacco use risk to at-risk LGBT young adults.

Read the detailed description

PRIMARY OBJECTIVES:

Identify absolute and relative risk anti-tobacco messages that effectively communicate polytobacco risks to lesbian, gay, bisexual, transgender (LGBT) young adults.

Participants view anti-tobacco messages and rate them for perceived effectiveness and reactance.

Conditions: Tobacco-Related Carcinoma
Being tested: Health communications

What participants receive

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

Health communicationsOther
Participants are assigned to view health communications with risk and efficacy statements.

Study groups in NCT05393869
Study group	Role	What they receive
AR-Quit	Experimental	Participants view messages with absolute risk and quit statements Receives: Other: Health communications
AR-Switch	Experimental	Participants view messages with absolute risk and switch statements Receives: Other: Health communications
AR-Combination	Experimental	Participants view messages with absolute risk and combination quit+switch statements Receives: Other: Health communications
RR-Quit	Experimental	Participants view messages with comparative risk and quit statements Receives: Other: Health communications
RR-Switch	Experimental	Participants view messages with comparative risk and switch statements Receives: Other: Health communications
RR-Combination	Experimental	Participants view messages with comparative risk and combination quit+switch statements Receives: Other: Health communications
Control	Other	Participants view FDA regulatory messages Receives: Other: Health communications

What is being measured

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

Message Perceived Effectiveness - Persuasive Potential.
6 items measured on 5-point scale, 1 = Not at all and 5 = Very much
- These messages were worth remembering.
- These messages grabbed my attention.
- These messages are powerful.
- These messages are convincing.
- These messages are meaningful.
- These messages are informative.
Responses were summed and averaged to create a scale for intention to quit (range from 1 - 5).
Higher scores indicate a higher persuasive potential of the message.
Measured: Immediately post-exposure to intervention, up to 1 hour
Perceived Effectiveness - Perceived Behavioral Impact
Six items were analyzed separately, each scored on 5-point Likert scale (1=Strongly Disagree, 5=Strongly Agree)
These messages will motivate CIGARETTE SMOKERS to switch to vaping.
These messages will motivate people to quit ALL smoking and vaping.
These messages will motivate NON-USERS to start vaping.
These messages will motivate NON-USERS to start smoking cigarettes.
These messages will motivate CIGARETTE SMOKERS to quit.
These messages will motivate VAPERS to quit.
Measured: Immediately post-exposure to intervention, up to 1 hour
Risk Perceptions: Absolute/Relative Risks of Cigarette vs. E-cigarette Use
On a scale from 0-10, where 0 = not at all harmful and 10 = extremely harmful now harmful are ... to your health?
- combustible cigarettes
- nicotine vapes
On a scale from 0-10, where 0 = much less harmful and 10 = much more harmful...
- compared to combustible cigarettes, how harmful are nicotine vapes to your health?
Measured: Immediately post-exposure to intervention, up to 1 hour
Behavioral Intentions to Use Tobacco
8-items made up two 4-pt scales (1 = definitely will not and 4 = definitely will).
Items for each scale were summed and averaged. Higher scores indicate higher likelihood of avoiding cigarettes/nicotine vapes.
How likely it is that in the next 3 months, you will refrain from...
- smoking cigarettes completely and permanently?
- smoking cigarettes when you get lonely?
- smoking cigarettes when you are with your friends who use them?
- smoking cigarettes when someone hands you a cigarette?
How likely it is that in the next 3 months, you will refrain from...
- vaping nicotine completely and permanently?
- vaping nicotine when you get lonely?
- vaping nicotine when you are with your friends who use them?
- vaping nicotine when someone hands you a vape?
Measured: Immediately post-exposure to intervention, up to 1 hour

Timeline

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

14 Apr 202114 Nov 2022

First posted26 May 2022
Study start14 Apr 2021
Primary completion14 Nov 2022
Study completion14 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Tobacco-Related CarcinomaStudies of the same condition, open and under way.
More trials run by Ohio State University Comprehensive 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: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Participant
Enrolment: 2,849 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05393869
Sponsor's protocol ID: OSU-20427
Other IDs: NCI-2022-02543, K99CA260718
Status last verified: Dec 2023
First submitted: 18 May 2022
Last updated: 26 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Tobacco-Related Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Nicotine and Tobacco Message Framing on Use Among Diverse Groups of Young Adults
ClinicalTrials.gov ID: NCT05393869
Acronym / sponsor ID: OSU-20427
Conditions: Tobacco-Related Carcinoma
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,849 participants (actual)
Lead sponsor: Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 14 Apr 2021 (actual)
Primary completion: 14 Nov 2022 (actual)
Study completion: 14 Nov 2022 (actual)
First posted: 26 May 2022 (actual)
Results: Posted 26 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

Identify absolute and relative risk anti-tobacco messages that effectively communicate polytobacco risks to lesbian, gay, bisexual, transgender (LGBT) young adults.

Participants view anti-tobacco messages and rate them for perceived effectiveness and reactance.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (participant)
Number of arms: 7

Arm	Type	Receives
AR-Quit	Experimental	Other: Health communicationsParticipants view messages with absolute risk and quit statements
AR-Switch	Experimental	Other: Health communicationsParticipants view messages with absolute risk and switch statements
AR-Combination	Experimental	Other: Health communicationsParticipants view messages with absolute risk and combination quit+switch statements
RR-Quit	Experimental	Other: Health communicationsParticipants view messages with comparative risk and quit statements
RR-Switch	Experimental	Other: Health communicationsParticipants view messages with comparative risk and switch statements
RR-Combination	Experimental	Other: Health communicationsParticipants view messages with comparative risk and combination quit+switch statements
Control	Other	Other: Health communicationsParticipants view FDA regulatory messages

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Young adults (age 18-35 years)
Live in the United States
Are susceptible to multiple nicotine and tobacco product use (i.e., have used combustible tobacco or e-cigarettes at least once)

Key exclusion criteria (0 listed)

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
Health communicationsParticipants are assigned to view health communications with risk and efficacy statements.	Other	AR-Combination, AR-Quit, AR-Switch, Control, RR-Combination, RR-Quit, RR-Switch

Primary outcome

Message Perceived Effectiveness - Persuasive Potential.
Time frame: Immediately post-exposure to intervention, up to 1 hour
6 items measured on 5-point scale, 1 = Not at all and 5 = Very much * These messages were worth remembering. * These messages grabbed my attention. * These messages are powerful. * These messages are convincing. * These messages are meaningful. * These messages are informative. Responses were summed and averaged to create a scale for intention to quit (range from 1 - 5). Higher scores indicate a higher persuasive potential of the message.
Perceived Effectiveness - Perceived Behavioral Impact
Time frame: Immediately post-exposure to intervention, up to 1 hour
Six items were analyzed separately, each scored on 5-point Likert scale (1=Strongly Disagree, 5=Strongly Agree) These messages will motivate CIGARETTE SMOKERS to switch to vaping. These messages will motivate people to quit ALL smoking and vaping. These messages will motivate NON-USERS to start vaping. These messages will motivate NON-USERS to start smoking cigarettes. These messages will motivate CIGARETTE SMOKERS to quit. These messages will motivate VAPERS to quit.
Risk Perceptions: Absolute/Relative Risks of Cigarette vs. E-cigarette Use
Time frame: Immediately post-exposure to intervention, up to 1 hour
On a scale from 0-10, where 0 = not at all harmful and 10 = extremely harmful now harmful are ... to your health? * combustible cigarettes * nicotine vapes On a scale from 0-10, where 0 = much less harmful and 10 = much more harmful... • compared to combustible cigarettes, how harmful are nicotine vapes to your health?
Behavioral Intentions to Use Tobacco
Time frame: Immediately post-exposure to intervention, up to 1 hour
8-items made up two 4-pt scales (1 = definitely will not and 4 = definitely will). Items for each scale were summed and averaged. Higher scores indicate higher likelihood of avoiding cigarettes/nicotine vapes. How likely it is that in the next 3 months, you will refrain from... * smoking cigarettes completely and permanently? * smoking cigarettes when you get lonely? * smoking cigarettes when you are with your friends who use them? * smoking cigarettes when someone hands you a cigarette? How likely it is that in the next 3 months, you will refrain from... * vaping nicotine completely and permanently? * vaping nicotine when you get lonely? * vaping nicotine when you are with your friends who use them? * vaping nicotine when someone hands you a vape?

Results and safety

Results posted to the registry on 26 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AR-Quit	407	400
AR-Switch	407	405
AR-Combination	407	398
RR-Quit	407	404
RR-Switch	407	402
RR-Combination	407	403
Control	407	404

Primary outcome: Message Perceived Effectiveness - Persuasive Potential.

Time frame: Immediately post-exposure to intervention, up to 1 hour. Mean (95% Confidence Interval). Unit: units on a scale

Measure	AR-Quit n = 399	AR-Switch n = 402	AR-Combination n = 396	RR-Quit n = 403	RR-Switch n = 401	RR-Combination n = 402	Control n = 402
Value	3.57 (3.47 to 3.67)	3.24 (3.13 to 3.35)	3.26 (3.15 to 3.36)	3.44 (3.33 to 3.54)	2.93 (2.42 to 3.44)	2.98 (2.48 to 3.49)	3.10 (2.96 to 3.24)

Population analysed: Analytic population only included participants who had no missing data for any scale items.

Primary outcome: Perceived Effectiveness - Perceived Behavioral Impact

Time frame: Immediately post-exposure to intervention, up to 1 hour. Mean (95% Confidence Interval). Unit: units on a scale

Measure	AR-Quit n = 403	AR-Switch n = 407	AR-Combination n = 399	RR-Quit n = 405	RR-Switch n = 403	RR-Combination n = 405	Control n = 405
These messages will motivate people to quit ALL smoking and vaping.	2.96 (2.84 to 3.08)	2.38 (2.25 to 2.50)	2.44 (2.32 to 2.56)	2.71 (2.59 to 2.84)	2.07 (1.96 to 2.19)	2.22 (2.11 to 2.34)	2.76 (2.63 to 2.88)
These messages will motivate CIGARETTE SMOKERS to quit.	3.11 (2.97 to 3.23)	3.10 (2.98 to 3.22)	3.16 (3.04 to 3.27)	3.28 (3.17 to 3.40)	3.00 (2.88 to 3.11)	3.17 (3.04 to 3.29)	2.82 (2.70 to 2.95)
These messages will motivate CIGARETTE SMOKERS to switch to vaping	2.10 (2.00 to 2.21)	3.52 (3.40 to 3.63)	3.41 (3.29 to 3.53)	3.34 (3.22 to 3.45)	3.67 (3.57 to 3.78)	3.67 (3.56 to 3.78)	1.81 (1.72 to 1.91)
These messages will motivate VAPERS to quit.	2.96 (2.84 to 3.08)	2.21 (2.09 to 2.33)	2.26 (2.14 to 2.37)	2.53 (2.41 to 2.64)	1.84 (1.73 to 1.94)	1.94 (1.83 to 2.04)	2.83 (2.71 to 2.95)
These messages will motivate NON-USERS to start vaping.	1.26 (1.20 to 1.33)	1.91 (1.80 to 2.02)	1.87 (1.75 to 1.98)	1.62 (1.53 to 1.72)	2.17 (2.05 to 2.29)	2.14 (2.02 to 2.26)	1.26 (1.20 to 1.33)
These messages will motivate NON-USERS to start smoking cigarettes.	1.24 (1.17 to 1.30)	1.29 (1.22 to 1.36)	1.35 (1.27 to 1.42)	1.21 (1.15 to 1.27)	1.30 (1.23 to 1.37)	1.32 (1.25 to 1.40)	1.24 (1.18 to 1.30)

Population analysed: Analytic population did not include participants with missing data for outcomes.

Primary outcome: Risk Perceptions: Absolute/Relative Risks of Cigarette vs. E-cigarette Use

Time frame: Immediately post-exposure to intervention, up to 1 hour. Mean (95% Confidence Interval). Unit: units on a scale

Measure	AR-Quit n = 399	AR-Switch n = 402	AR-Combination n = 396	RR-Quit n = 403	RR-Switch n = 402	RR-Combination n = 402	Control n = 403
Absolute harm of cigarettes to health	9.08 (8.95 to 9.21)	9.07 (8.93 to 9.21)	8.97 (8.82 to 9.12)	9.11 (8.98 to 9.24)	9.06 (8.93 to 9.20)	9.04 (8.89 to 9.19)	8.94 (8.79 to 9.09)
Absolute harm of nicotine vapes to health	7.57 (7.35 to 7.79)	7.05 (6.83 to 7.27)	7.19 (6.96 to 7.42)	7.19 (6.97 to 7.42)	6.88 (6.64 to 7.11)	6.94 (6.71 to 7.17)	7.57 (7.34 to 7.80)
Relative harm of nicotine vapes (vs combustible cigarettes) to health	4.99 (4.71 to 5.26)	4.65 (4.38 to 4.92)	4.81 (4.51 to 5.11)	4.46 (4.16 to 4.75)	4.34 (4.05 to 4.64)	4.49 (4.20 to 4.78)	5.04 (4.77 to 5.30)

Population analysed: Analytic population included participants with no missing data on outcomes.

Primary outcome: Behavioral Intentions to Use Tobacco

Time frame: Immediately post-exposure to intervention, up to 1 hour. Mean (95% Confidence Interval). Unit: units on a scale

Measure	AR-Quit n = 403	AR-Switch n = 407	AR-Combination n = 399	RR-Quit n = 405	RR-Switch n = 403	RR-Combination n = 405	Control n = 405
Behavioral intentions to use nicotine vapes	3.27 (3.17 to 3.36)	3.16 (3.06 to 3.26)	3.16 (3.06 to 3.27)	3.22 (3.12 to 3.31)	3.11 (3.01 to 3.22)	3.17 (3.07 to 3.27)	3.15 (3.04 to 3.25)
Behavioral intentions to smoke cigarettes	3.48 (3.40 to 3.56)	3.40 (3.31 to 3.49)	3.40 (3.30 to 3.49)	3.46 (3.37 to 3.54)	3.46 (3.38 to 3.55)	3.44 (3.35 to 3.52)	3.37 (3.28 to 3.46)

Population analysed: Analytic population included participants who did not have missing data on outcomes.

Adverse events

Time frame: 1 hour post-baseline. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AR-Quit	0 of 407 (0%)	0 of 407 (0%)	0 of 407
AR-Switch	0 of 407 (0%)	0 of 407 (0%)	0 of 407
AR-Combination	0 of 407 (0%)	0 of 407 (0%)	0 of 407
RR-Quit	0 of 407 (0%)	0 of 407 (0%)	0 of 407
RR-Switch	0 of 407 (0%)	0 of 407 (0%)	0 of 407
RR-Combination	0 of 407 (0%)	0 of 407 (0%)	0 of 407
Control	0 of 407 (0%)	0 of 407 (0%)	0 of 407

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
The JameslineLink provided by the sponsor.
Individual participant dataSharing planned: No

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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.

Joanne G Patterson, PhD MPH MSW principal investigator

Ohio State University Comprehensive 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 Health communications 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 4 inclusion and 0 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 26 Dec 2023. 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?

Yes. Results are posted in the registry (first posted 26 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Message Perceived Effectiveness - Persuasive Potential. (time frame: Immediately post-exposure to intervention, up to 1 hour). The study lists 4 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 NCT05393869.

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 26 Dec 2023.