Tracking risk awareness and improving knowledge about alcohol-related breast cancer in young adult women
Alcohol Counter Marketing as a Breast Cancer Prevention Strategy in Young Women
This project will test whether co-created digital messages can reduce drinking and increase young women's awareness that alcohol raises breast cancer risk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 25 Years |
| Sex | Female |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT07320664 on ClinicalTrials.gov |
What this trial studies
This randomized behavioral trial enrolls women assigned female at birth aged 18–25 who have consumed alcohol in the past 30 days and live in five Midwestern/Atlantic states. Participants are randomized 1:1 to receive co-created counter-marketing messages about alcohol and breast cancer twice weekly for six weeks or to a control arm receiving text-only skin cancer risk/prevention messages at the same dose. The intervention content was co-created with young adult women using real-time discussions and AI text-to-image tools and was refined before testing. Up to 10% of participants in each arm will be randomly selected to wear a wrist-worn transdermal alcohol biosensor (iPhone required for that subgroup) to capture objective drinking measures remotely.
Who should consider this trial
Good fit: Eligible participants are people assigned female at birth, aged 18–25, who drank alcohol at least once in the past 30 days, are not pregnant or planning pregnancy, live in Ohio, Michigan, Illinois, Wisconsin, or New Jersey, and can receive smartphone text/image messages (with iPhone required for the biosensor subgroup).
Not a fit: People who do not drink, are pregnant or intending pregnancy, are outside the 18–25 age range, are assigned male at birth, or live outside the eligible states are not eligible and therefore would not receive benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could reduce alcohol use and increase understanding of alcohol-related breast cancer risk among young adult women, potentially lowering future cancer risk.
How similar studies have performed: Prior digital brief interventions and counter-marketing approaches have shown modest success in changing young adults' alcohol-related attitudes and behaviors, but the specific use of co-created AI-generated counter-marketing content is novel and less tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Assigned female at birth. * Age 18-25 at enrollment. * Report drinking alcohol at least once in the past 30 days. * Not pregnant or intending to become pregnant by self-report. * Reside in Ohio, Michigan, Illinois, Wisconsin, or New Jersey. * Willing to complete procedures. * Able to complete procedures a, b, or c: 1. Can read, write, and converse in English. 2. Has a personal mobile smartphone with texting capabilities to receive text messages that may contain text and images. 3. For the subsample who will wear the BACTrack sensor, they must have an iPhone. At the time of this protocol, the BACTrack skyn app is only compatible with iPhones. If this expands to Android phones over the course of the study, Android phones will be eligible. Exclusion Criteria: * Assigned male at birth * Ages \<18 or \>25 at enrollment * Do not report drinking alcohol at least once in the past 30 days * Pregnant or intending to become pregnant by self-report. * Do not reside in Ohio, Michigan, Illinois, Wisconsin, or New Jersey. * Not willing to complete procedures. * Unable to complete procedures.
Where this trial is running
Columbus, Ohio
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Darren Mays, MPH, PhD — Ohio State University Comprehensive Cancer Center
- Study coordinator: The Ohio State University Comprehensive Cancer Center
- Email: OSUCCCClinicaltrials@osumc.edu
- Phone: 800-293-5066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.