AlcoholNCT07365813
Testing Alcohol Cancer Risk Messages
A study testing Text-only messages, AI-developed Neutral pictorial messages and AI-developed graphic pictorial messages in people with Alcohol and Cancer, run by University of Miami at 1 site in United States.
Trial summary
Testing gain vs loss-framed messages to address drinking among cancer survivors Read more about this study
- Who is it for?
- Ages 21 years and older
- What is being tested?
- Text-only messages, AI-developed Neutral pictorial messages and AI-developed graphic pictorial messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2026to 30 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 years or older
- Resident of the United States
- Able to read and speak English
- Diagnosed with one of the following cancers: mouth, throat, larynx, liver, colon, rectum, or breast
- Current alcohol user (≥ 1 alcoholic drink in the past 30 days)
Who cannot join
- Adults unable to consent
- Individuals younger than 21
- Not residing in the US
- Non-alcohol users (<1 drink)
- Less than 50% completion of the survey
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Developing and Testing AI-Generated Messages on Alcohol and Cancer Risk: A Proof of Concept
Testing gain vs loss-framed messages to address drinking among cancer survivors
- Being tested
- Text-only messages, AI-developed Neutral pictorial messages, AI-developed graphic pictorial messages
- Keywords
- alcohol, alcohol warning labels, cancer survivors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text-only messagesBehavioural
The study will test eight alcohol-cancer risk messages (four gain-framed and four loss-framed). Each message will be developed at three intensity levels (text-only, neutral image, and graphic image), yielding 24 total message stimuli.
AI-developed Neutral pictorial messagesBehavioural
The study will test eight alcohol-cancer risk messages (four gain-framed and four loss-framed). Each message will be developed at three intensity levels (text-only, neutral image, and graphic image), yielding 24 total message stimuli.
AI-developed graphic pictorial messagesBehavioural
The study will test eight alcohol-cancer risk messages (four gain-framed and four loss-framed). Each message will be developed at three intensity levels (text-only, neutral image, and graphic image), yielding 24 total message stimuli.
| Study group | Role | What they receive |
|---|---|---|
| Gain-framed Messages | Experimental | The study will test in an online 15 minutes single session, four gain-framed alcohol-cancer risk messages. Each message will be viewed in three intensity levels (text-only, neutral image, and graphic image), yielding 12 total message stimuli. Receives: Behavioral: Text-only messages; Behavioral: AI-developed Neutral pictorial messages; Behavioral: AI-developed graphic pictorial messages |
| Loss-Framed Messages | Experimental | The study will test in an online 15 minutes single session, four loss-framed alcohol-cancer risk messages. Each message will be viewed in three intensity levels (text-only, neutral image, and graphic image), yielding 12 total message stimuli. Receives: Behavioral: Text-only messages; Behavioral: AI-developed Neutral pictorial messages; Behavioral: AI-developed graphic pictorial messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in alcohol-cancer harm perception
Change in participants' beliefs about experiencing cancer in the future due to alcohol use measured on a scale from 1 (not at all) to 5 (a lot). The outcome is the change on the mean score from the pre to post exposure.
Measured: Within 15 minutes on a single online session - from before message exposure (pre-exposure) to after message exposure (post-exposure).
Intention to Reduce Alcohol consumption
Change in participants' intention to reduce alcohol consumption in the next month, measured on a scale from 1 (not at all) to 5 (a lot). The outcome is the change on the mean score from the pre to post exposure.
Measured: Within 15 minutes on a single online session - from before message exposure (pre-exposure) to after message exposure (post-exposure).
Commitment to a limited drinking goal in the next month
Change in participants' intention to commit to a drinking limit goal in the next month, measured on a scale from 1 (not at all) to 5 (a lot). The outcome is the change on the mean score from the pre to post exposure.
Measured: Within 15 minutes on a single online session - from before message exposure (pre-exposure) to after message exposure (post-exposure).
Secondary outcomes (2)
Message perceived effectiveness
Self reported perceived overall effectiveness of the message measured on a scale from 1 (not at all) to 5 (a lot) scale. The outcome is the mean score.
Measured: One time (within 5 minutes) post-exposure evaluation.
Message Receptivity
Self reported message receptivity including attention, emotional reaction, believability, fear, relevance, anticipated social interactions, recall and avoidance on a scale from 1 (not at all) to 5 (a lot). The outcome is the composite mean score assessing attention, emotional reaction, believability, fear, relevance, anticipated social interactions, recall, avoidance, and perceived effectiveness. Higher scores indicate greater message receptivity.
Measured: One time (within 5 minutes) post-exposure evaluation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start21 Apr 2026
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- None (open label)
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taghrid Asfar, University of Miami
- Investigators
- Taghrid Asfar, MD, MSPH, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365813
- Sponsor's protocol ID
- 20250012
- Status last verified
- Oct 2026
- First submitted
- 16 Jan 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing AI-Generated Messages on Alcohol and Cancer Risk: A Proof of Concept
- ClinicalTrials.gov ID
- NCT07365813
- Acronym / sponsor ID
- 20250012
- Keywords
- alcohol, alcohol warning labels, cancer survivors
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Testing gain vs loss-framed messages to address drinking among cancer survivors
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gain-framed Messages | Experimental | Behavioral: Text-only messages, Behavioral: AI-developed Neutral pictorial messages, Behavioral: AI-developed graphic pictorial messagesThe study will test in an online 15 minutes single session, four gain-framed alcohol-cancer risk messages. Each message will be viewed in three intensity levels (text-only, neutral image, and graphic image), yielding 12 total message stimuli. |
| Loss-Framed Messages | Experimental | Behavioral: Text-only messages, Behavioral: AI-developed Neutral pictorial messages, Behavioral: AI-developed graphic pictorial messagesThe study will test in an online 15 minutes single session, four loss-framed alcohol-cancer risk messages. Each message will be viewed in three intensity levels (text-only, neutral image, and graphic image), yielding 12 total message stimuli. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 21 years or older
- Resident of the United States
- Able to read and speak English
- Diagnosed with one of the following cancers: mouth, throat, larynx, liver, colon, rectum, or breast
- Current alcohol user (≥ 1 alcoholic drink in the past 30 days)
Key exclusion criteria (5 listed)
- Adults unable to consent
- Individuals younger than 21
- Not residing in the US
- Non-alcohol users (<1 drink)
- Less than 50% completion of the survey
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 |
|---|---|---|
| Text-only messagesThe study will test eight alcohol-cancer risk messages (four gain-framed and four loss-framed). Each message will be developed at three intensity levels (text-only, neutral image, and graphic image), yielding 24 total message stimuli. | Behavioural | Gain-framed Messages, Loss-Framed Messages |
| AI-developed Neutral pictorial messagesThe study will test eight alcohol-cancer risk messages (four gain-framed and four loss-framed). Each message will be developed at three intensity levels (text-only, neutral image, and graphic image), yielding 24 total message stimuli. | Behavioural | Gain-framed Messages, Loss-Framed Messages |
| AI-developed graphic pictorial messagesThe study will test eight alcohol-cancer risk messages (four gain-framed and four loss-framed). Each message will be developed at three intensity levels (text-only, neutral image, and graphic image), yielding 24 total message stimuli. | Behavioural | Gain-framed Messages, Loss-Framed Messages |
Primary outcome
Change in alcohol-cancer harm perception
Time frame: Within 15 minutes on a single online session - from before message exposure (pre-exposure) to after message exposure (post-exposure).
Change in participants' beliefs about experiencing cancer in the future due to alcohol use measured on a scale from 1 (not at all) to 5 (a lot). The outcome is the change on the mean score from the pre to post exposure.
Intention to Reduce Alcohol consumption
Time frame: Within 15 minutes on a single online session - from before message exposure (pre-exposure) to after message exposure (post-exposure).
Change in participants' intention to reduce alcohol consumption in the next month, measured on a scale from 1 (not at all) to 5 (a lot). The outcome is the change on the mean score from the pre to post exposure.
Commitment to a limited drinking goal in the next month
Time frame: Within 15 minutes on a single online session - from before message exposure (pre-exposure) to after message exposure (post-exposure).
Change in participants' intention to commit to a drinking limit goal in the next month, measured on a scale from 1 (not at all) to 5 (a lot). The outcome is the change on the mean score from the pre to post exposure.
2 secondary outcomes
Message perceived effectiveness
Time frame: One time (within 5 minutes) post-exposure evaluation.
Message Receptivity
Time frame: One time (within 5 minutes) post-exposure evaluation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- 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.
Taghrid Asfar, MD, MSPH principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text-only messages, AI-developed Neutral pictorial messages and AI-developed graphic pictorial messages in people with Alcohol and Cancer, run by University of Miami 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 5 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 20 Oct 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in alcohol-cancer harm perception (time frame: Within 15 minutes on a single online session - from before message exposure (pre-exposure) to after message exposure (post-exposure).). 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?
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 20 Oct 2026.