- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07365813
Testing Alcohol Cancer Risk Messages
May 20, 2026 updated by: Taghrid Asfar, University of Miami
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
Study Overview
Status
Enrolling by invitation
Study Type
Interventional
Enrollment (Estimated)
850
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- University of Miami
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Gain-framed Messages
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.
|
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.
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.
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.
|
|
Experimental: Loss-Framed Messages
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.
|
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
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.
|
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
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.
|
Within 15 minutes on a single online session - from before message exposure (pre-exposure) to after message exposure (post-exposure).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Message perceived effectiveness
Time Frame: One time (within 5 minutes) post-exposure evaluation.
|
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.
|
One time (within 5 minutes) post-exposure evaluation.
|
|
Message Receptivity
Time Frame: One time (within 5 minutes) post-exposure evaluation.
|
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.
|
One time (within 5 minutes) post-exposure evaluation.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Taghrid Asfar, MD, MSPH, University of Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 21, 2026
Primary Completion (Estimated)
March 30, 2028
Study Completion (Estimated)
March 30, 2028
Study Registration Dates
First Submitted
January 16, 2026
First Submitted That Met QC Criteria
January 16, 2026
First Posted (Actual)
January 26, 2026
Study Record Updates
Last Update Posted (Actual)
May 22, 2026
Last Update Submitted That Met QC Criteria
May 20, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20250012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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