Oral CancerNCT06129487
Evaluations of Alcohol Warning Labels
A study testing Narrative pictorial warning labels for alcoholic beverages and Non-narrative pictorial warning labels for alcoholic beverages in people with Oral Cancer and Esophageal Cancer, run by University of Connecticut at 1 site in United States.
Trial summary
The goal of this study is to determine the effectiveness of pictorial warning labels (PWLs) featuring narrative (vs. non-narrative) content in communicating the cancer risk of alcohol. Participants will be randomized to view either three narrative or non-narrative PWLs. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Cancer, Esophageal Cancer, Larynx Cancer
- What is being tested?
- Narrative pictorial warning labels for alcoholic beverages and Non-narrative pictorial warning labels for alcoholic beverages
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,053 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2024to 27 Mar 2024
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be at least 21 years old;
- have consumed more than three alcoholic drinks per week over the past year;
- be willing to participate in remote eye tracking tasks and have necessary technical support to complete remote eye tracking tasks (i.e., having access to high-speed Internet and a computer/tablet/phone equipped with a high-speed camera).
Who cannot join
- be younger than 21 years old;
- has not consumed more than three alcoholic drinks per week over the past year;
- be not willing to participate in remote eye tracking tasks and have no necessary technical support to complete remote eye tracking tasks (i.e., having access to high-speed Internet and a computer/tablet/phone equipped with a high-speed camera).
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to determine the effectiveness of pictorial warning labels (PWLs) featuring narrative (vs. non-narrative) content in communicating the cancer risk of alcohol. Participants will be randomized to view either three narrative or non-narrative PWLs. Key outcome variables include visual attention, message reactance, risk perceptions, and intentions to reduce and stop drinking.
Read the detailed description
The goal of this study is to determine the effectiveness of pictorial warning labels (PWLs) featuring narrative (vs. non-narrative) content in communicating the cancer risk of alcohol. Participants will be recruited from online panels. Participants will first be invited to participate in an online screening survey. Eligible participants will be invited to participate in the main experiment. In the main experiment, participants will first answer questions concerning baseline alcohol consumption and other background information. Then they will engage with a webcam-based eye-tracking task through Sticky by Tobii. Participants will first read instructions and tips related to completing the eye-tracking task. They will complete a brief calibration procedure and be presented with either three narrative PWLs or three non-narrative PWLs. Sticky by Tobii will record participants' gaze, thereby measuring visual attention to each PWL. After viewing each PWL, participants will answer a few questions. After viewing all three PWLs, they will answer questions based on all images combined. Upon study completion, participants will be compensated. A follow-up survey will be sent to participants after two weeks, which includes questions about their drinking behaviors, information seeking behaviors, and social interactions.
- Conditions
- Oral Cancer, Esophageal Cancer, Larynx Cancer, Alcohol Drinking
- Being tested
- Narrative pictorial warning labels for alcoholic beverages, Non-narrative pictorial warning labels for alcoholic beverages
- Medical subject headings
- Mouth Neoplasms, Esophageal Neoplasms, Laryngeal Neoplasms, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative pictorial warning labels for alcoholic beveragesBehavioural
Pictorial warning labels consisting of text and narrative imagery (e.g., photos of cancer patients) conveying the risk of alcohol for oral cancer, esophageal cancer, and larynx cancer.
Non-narrative pictorial warning labels for alcoholic beveragesBehavioural
Pictorial warning labels consisting of text and non-narrative imagery (e.g., images of diseased organs) conveying the risk of alcohol for oral cancer, esophageal cancer, and larynx cancer.
| Study group | Role | What they receive |
|---|---|---|
| Narrative Pictorial Warning Labels | Experimental | Participants in this arm will be presented with three narrative pictorial warning labels for alcoholic beverages. Receives: Behavioral: Narrative pictorial warning labels for alcoholic beverages |
| Non-Narrative Pictorial Warning Labels | Experimental | Participants in this arm will be presented with three non-narrative pictorial warning labels for alcoholic beverages. Receives: Behavioral: Non-narrative pictorial warning labels for alcoholic beverages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dwell Time
Dwell time measures the total duration of attention to an area of interest (AOI). Each warning label consisted of two AOIs: image AOI and text AOI. Dwell time for each AOI was averaged across three PWLs within each arm.
Measured: Assessed during the one-time 15-minute online survey experiment.
Visit Count
Visit count measures the total number of times participants viewed an area of interest (AOI). Each warning label consisted of two AOIs: image AOI and text AOI. Visit count for each AOI was averaged across three PWLs within each arm.
Measured: Assessed during the one-time 15-minute online survey experiment.
Reactance
Reactance were measured after exposure to each PWL (i.e., three times in total). It was assessed using the brief Reactance to Health Warnings Scale (Hall et al., 2017). Participants were asked to indicate how much each warning tried to manipulate them, annoyed them, and was overblown (1 = not at all, 5 = a great deal). Reactance for each PWL was averaged across three PWLs within each arm.
Measured: Assessed during the one-time 15-minute online survey experiment.
Affective Risk Perceptions
Affective risk perceptions were assessed once after participants viewed all three PWLs. Participants were asked to indicate how worried they are about getting a specific type of cancer if they keep drinking the amount of alcohol like they do now. Participants responded on a five-point scale (1 = Not at all worried, 2=Slightly worried, 3=Moderately worried, 4=Very worried, 5=Extremely worried).
Measured: Assessed during the one-time 15-minute online survey experiment.
Experiential Risk Perceptions
Experiential risk perceptions were assessed once after participants viewed all three PWLs. Participants were asked to indicate how vulnerable they feel about getting a specific type of cancer if they keep drinking the amount of alcohol like they do now. Participants responded on a five-point scale (1 = Not at all vulnerable, 2=Slightly vulnerable, 3=Moderately vulnerable, 4=Very vulnerable, 5=Extremely vulnerable).
Measured: Assessed during the one-time 15-minute online survey experiment.
Perceived Susceptibility
Perceived susceptibility were assessed once after participants viewed all three PWLs. Participants were asked to indicate how likely it is that they will get a specific type of cancer if they keep drinking the amount of alcohol like they do now. Participants responded on a five-point scale (1 = Not at all likely, 2=A little likely, 3=Somewhat likely, 4=Very likely, 5=Extremely likely).
Measured: Assessed during the one-time 15-minute online survey experiment.
Comparative Risk
Comparative risk were assessed once after participants viewed all three PWLs. Participants were asked to indicate compared to an average person their age, race, and sex, how likely do they think they will get a specific type of cancer if they keep drinking the amount of alcohol like they do now. Participants responded on a five-point scale (1=Much less likely, 2=Less likely, 3=About as likely, 4=More likely, 5=Much more likely).
Measured: Assessed during the one-time 15-minute online survey experiment.
Perceived Severity of Harm
Perceived severity of harm were assessed once after participants viewed all three PWLs. Participants were asked to indicate how much getting a specific type of cancer because of drinking would affect their life. Participants responded on a five-point scale (1=Not at all, 2=Very little, 3=Somewhat, 4=Quite a bit, 5=A great deal).
Measured: Assessed during the one-time 15-minute online survey experiment.
Intentions to Reduce Drinking
Intentions to reduce drinking were assessed once after participants viewed all three PWLs. Participants were asked to answer questions such as "How interested are you in reducing drinking in the next 6 months?" Participants responded to these questions on an appropriately labeled 5-point scale (e.g., 1 = Not at all interested, 2=Slightly interested, 3=Moderately interested, 4=Very interested, 5=Extremely interested).
Measured: Assessed during the one-time 15-minute online survey experiment.
Intentions to Stop Drinking
Intentions to stop drinking were assessed once after participants viewed all three PWLs. Participants were asked to answer three questions such as "How interested are you in stopping drinking in the next 6 months?" Participants responded to these questions on an appropriately labeled 5-point scale (e.g., 1 = Not at all interested, 2=Slightly interested, 3=Moderately interested, 4=Very interested, 5=Extremely interested).
Measured: Assessed during the one-time 15-minute online survey experiment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start19 Jan 2024
- Primary completion6 Mar 2024
- Study completion27 Mar 2024
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 Oral CancerStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,053 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- Oakland University, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Zexin Ma, University of Connecticut
- Investigators
- Zexin Ma, Ph.D., Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129487
- Sponsor's protocol ID
- B2023-0021
- Other IDs
- 7R03CA273391-02
- Status last verified
- Oct 2025
- First submitted
- 2 Nov 2023
- Last updated
- 14 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified dataset, study protocol, sample informed consent, and data dictionary will be made available to the research community free of charge through ICPSR (https://www.openicpsr.org/).
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluations of Alcohol Warning Labels
- ClinicalTrials.gov ID
- NCT06129487
- Acronym / sponsor ID
- B2023-0021
- Conditions
- Oral Cancer, Esophageal Cancer, Larynx Cancer, Alcohol Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,053 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- Oakland University, National Cancer Institute (NCI)
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 6 Mar 2024 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 13 Nov 2023 (actual)
- Results
- Posted 14 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to determine the effectiveness of pictorial warning labels (PWLs) featuring narrative (vs. non-narrative) content in communicating the cancer risk of alcohol. Participants will be randomized to view either three narrative or non-narrative PWLs. Key outcome variables include visual attention, message reactance, risk perceptions, and intentions to reduce and stop drinking.
Detailed description
The goal of this study is to determine the effectiveness of pictorial warning labels (PWLs) featuring narrative (vs. non-narrative) content in communicating the cancer risk of alcohol. Participants will be recruited from online panels. Participants will first be invited to participate in an online screening survey. Eligible participants will be invited to participate in the main experiment. In the main experiment, participants will first answer questions concerning baseline alcohol consumption and other background information. Then they will engage with a webcam-based eye-tracking task through Sticky by Tobii. Participants will first read instructions and tips related to completing the eye-tracking task. They will complete a brief calibration procedure and be presented with either three narrative PWLs or three non-narrative PWLs. Sticky by Tobii will record participants' gaze, thereby measuring visual attention to each PWL. After viewing each PWL, participants will answer a few questions. After viewing all three PWLs, they will answer questions based on all images combined. Upon study completion, participants will be compensated. A follow-up survey will be sent to participants after two weeks, which includes questions about their drinking behaviors, information seeking behaviors, and social interactions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narrative Pictorial Warning Labels | Experimental | Behavioral: Narrative pictorial warning labels for alcoholic beveragesParticipants in this arm will be presented with three narrative pictorial warning labels for alcoholic beverages. |
| Non-Narrative Pictorial Warning Labels | Experimental | Behavioral: Non-narrative pictorial warning labels for alcoholic beveragesParticipants in this arm will be presented with three non-narrative pictorial warning labels for alcoholic beverages. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- be at least 21 years old;
- have consumed more than three alcoholic drinks per week over the past year;
- be willing to participate in remote eye tracking tasks and have necessary technical support to complete remote eye tracking tasks (i.e., having access to high-speed Internet and a computer/tablet/phone equipped with a high-speed camera).
Key exclusion criteria (3 listed)
- be younger than 21 years old;
- has not consumed more than three alcoholic drinks per week over the past year;
- be not willing to participate in remote eye tracking tasks and have no necessary technical support to complete remote eye tracking tasks (i.e., having access to high-speed Internet and a computer/tablet/phone equipped with a high-speed camera).
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 |
|---|---|---|
| Narrative pictorial warning labels for alcoholic beveragesPictorial warning labels consisting of text and narrative imagery (e.g., photos of cancer patients) conveying the risk of alcohol for oral cancer, esophageal cancer, and larynx cancer. | Behavioural | Narrative Pictorial Warning Labels |
| Non-narrative pictorial warning labels for alcoholic beveragesPictorial warning labels consisting of text and non-narrative imagery (e.g., images of diseased organs) conveying the risk of alcohol for oral cancer, esophageal cancer, and larynx cancer. | Behavioural | Non-Narrative Pictorial Warning Labels |
Primary outcome
Dwell Time
Time frame: Assessed during the one-time 15-minute online survey experiment.
Dwell time measures the total duration of attention to an area of interest (AOI). Each warning label consisted of two AOIs: image AOI and text AOI. Dwell time for each AOI was averaged across three PWLs within each arm.
Visit Count
Time frame: Assessed during the one-time 15-minute online survey experiment.
Visit count measures the total number of times participants viewed an area of interest (AOI). Each warning label consisted of two AOIs: image AOI and text AOI. Visit count for each AOI was averaged across three PWLs within each arm.
Reactance
Time frame: Assessed during the one-time 15-minute online survey experiment.
Reactance were measured after exposure to each PWL (i.e., three times in total). It was assessed using the brief Reactance to Health Warnings Scale (Hall et al., 2017). Participants were asked to indicate how much each warning tried to manipulate them, annoyed them, and was overblown (1 = not at all, 5 = a great deal). Reactance for each PWL was averaged across three PWLs within each arm.
Affective Risk Perceptions
Time frame: Assessed during the one-time 15-minute online survey experiment.
Affective risk perceptions were assessed once after participants viewed all three PWLs. Participants were asked to indicate how worried they are about getting a specific type of cancer if they keep drinking the amount of alcohol like they do now. Participants responded on a five-point scale (1 = Not at all worried, 2=Slightly worried, 3=Moderately worried, 4=Very worried, 5=Extremely worried).
Experiential Risk Perceptions
Time frame: Assessed during the one-time 15-minute online survey experiment.
Experiential risk perceptions were assessed once after participants viewed all three PWLs. Participants were asked to indicate how vulnerable they feel about getting a specific type of cancer if they keep drinking the amount of alcohol like they do now. Participants responded on a five-point scale (1 = Not at all vulnerable, 2=Slightly vulnerable, 3=Moderately vulnerable, 4=Very vulnerable, 5=Extremely vulnerable).
Perceived Susceptibility
Time frame: Assessed during the one-time 15-minute online survey experiment.
Perceived susceptibility were assessed once after participants viewed all three PWLs. Participants were asked to indicate how likely it is that they will get a specific type of cancer if they keep drinking the amount of alcohol like they do now. Participants responded on a five-point scale (1 = Not at all likely, 2=A little likely, 3=Somewhat likely, 4=Very likely, 5=Extremely likely).
Comparative Risk
Time frame: Assessed during the one-time 15-minute online survey experiment.
Comparative risk were assessed once after participants viewed all three PWLs. Participants were asked to indicate compared to an average person their age, race, and sex, how likely do they think they will get a specific type of cancer if they keep drinking the amount of alcohol like they do now. Participants responded on a five-point scale (1=Much less likely, 2=Less likely, 3=About as likely, 4=More likely, 5=Much more likely).
Perceived Severity of Harm
Time frame: Assessed during the one-time 15-minute online survey experiment.
Perceived severity of harm were assessed once after participants viewed all three PWLs. Participants were asked to indicate how much getting a specific type of cancer because of drinking would affect their life. Participants responded on a five-point scale (1=Not at all, 2=Very little, 3=Somewhat, 4=Quite a bit, 5=A great deal).
Intentions to Reduce Drinking
Time frame: Assessed during the one-time 15-minute online survey experiment.
Intentions to reduce drinking were assessed once after participants viewed all three PWLs. Participants were asked to answer questions such as "How interested are you in reducing drinking in the next 6 months?" Participants responded to these questions on an appropriately labeled 5-point scale (e.g., 1 = Not at all interested, 2=Slightly interested, 3=Moderately interested, 4=Very interested, 5=Extremely interested).
Intentions to Stop Drinking
Time frame: Assessed during the one-time 15-minute online survey experiment.
Intentions to stop drinking were assessed once after participants viewed all three PWLs. Participants were asked to answer three questions such as "How interested are you in stopping drinking in the next 6 months?" Participants responded to these questions on an appropriately labeled 5-point scale (e.g., 1 = Not at all interested, 2=Slightly interested, 3=Moderately interested, 4=Very interested, 5=Extremely interested).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The de-identified dataset, study protocol, sample informed consent, and data dictionary will be made available to the research community free of charge through ICPSR (https://www.openicpsr.org/).
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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.
Zexin Ma, Ph.D. principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrative pictorial warning labels for alcoholic beverages and Non-narrative pictorial warning labels for alcoholic beverages in people with Oral Cancer and Esophageal Cancer, run by University of Connecticut 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 3 inclusion and 3 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 14 Nov 2025. 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 14 Nov 2025). 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?
Dwell Time (time frame: Assessed during the one-time 15-minute online survey experiment.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2025.