An interventional study of Alcohol and Breast Cancer Risk Messages and Skin Cancer Risk Messages in Behavior, Risk, sponsored by Ohio State University Comprehensive Cancer Center. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-25.
Sponsored by Ohio State University Comprehensive Cancer Center · Not applicable, Interventional, and Prevention
Among 84 studies in Risk-Taking with a site in United States — 9 open to participants now, 11 under way, none of them phase 3. Risk-Taking · United States.
Among the 84 studies in Risk-Taking with a site in United States, this one is the 21st largest by planned enrollment of the 77 interventional ones, is one of 3 that started in 2026, is one of 60 with no phase, reaches primary completion later than 4 of the 10 other live ones, and was the 82nd registered.
136 studies on the registry are indexed under Risk-Taking; 18 are open to participants now.
This study's planned enrollment of 500 is above the median of 255 across 117 interventional studies indexed under Risk-Taking.
Browse Risk-Taking studies →9 of the 84 studies in Risk-Taking with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 15 Risk-Taking studies recruiting now, 4 (27%) set no upper age limit and 11 (73%) stop at 75 or younger; 8 take children under 18; 9 take healthy volunteers.
This study: 18 Years to 25 Years · female · healthy volunteers too.
The full table on the hub →84 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 3 started in 2026.
Median enrollment 237 across the 77 interventional studies, 120 across the 7 observational. Of the 69 that completed or were terminated, 19 (28%) have results posted.
None of the 84 has an industry lead sponsor. The 10 most frequent:
Ohio State University Comprehensive Cancer Center is the lead sponsor of 377 studies on the registry; 84 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.
Ohio State University Comprehensive Cancer Center has 3 studies filed under Risk-Taking — fewer than ten, so there is no comparison to draw.
4 of the studies in Risk-Taking with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06684613Yale UniversityIntegrating PrEP Decision Making Into Counseling in Sexual and Reproductive Health Clinics | 2027-03-01 |
| NCT05576350University of KentuckyTRAC-ER Intervention to Reduce Risky Alcohol Use and HIV Risk | 2027-05 |
| NCT07320664Ohio State University Comprehensive Cancer CenterBreast Cancer Study Tracking Risk Awareness of Alcohol Consumption and Improving Knowledge in Young Adult Women | 2027-07-01 |
| NCT04110756University of California, San FranciscoChangeGradients: Promoting Adolescent Health Behavior Change | 2027-07-31 |
Among the 84 studies in Risk-Taking with a site in United States, from their registry updates:
This randomized trial aims to test the effects of co-created breast cancer counter marketing intervention messages for reducing alcohol consumption and impacting awareness and beliefs about the breast cancer risks from alcohol consumption in young adult women.
This is an experimental behavioral study that builds upon prior work that engaged young adult women to collaboratively co-create counter marketing intervention content designed for digital media using open artificial intelligence, text-to-image content generation platform during real-time discussions. This study will test the refined and finalized co-created intervention content in a randomized trial by measuring alcohol consumption behavior and awareness and beliefs about the breast cancer risks from alcohol consumption. Participants will be randomized in a 1:1 ratio to the intervention arm or to a control arm. Participants in the intervention arm will receive the co-created intervention content twice a week for 6 weeks. Participants in the control arm will receive text only content about skin cancer risk and prevention for the same duration and dose. Up to 10% of participants from each trial arm will be randomly selected to wear a wrist-worm transdermal alcohol biosensor to capture an objective biochemical measure of alcohol consumption remotely.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Able to complete procedures a, b, or c:
Exclusion Criteria:
Participants in the intervention arm will receive the co-created intervention content about alcohol as a risk factor for breast cancer. The investigators will deliver links to the content by text messages to participants' mobile phones.
Behavioral: Alcohol and Breast Cancer Risk Messages
Participants in the control arm will receive text only content about skin cancer risk and prevention. The investigators will deliver links to the content by text messages to participants' mobile phones.
Behavioral: Skin Cancer Risk Messages
Participants will be randomized in a 1:1 ratio to the intervention or control arm. In the intervention arm, participants will receive the co-created intervention content. The investigators co-created the intervention content, including visuals and text, through focus groups with young adult women and refined the draft content based on additional feedback from focus groups, thereby ascertaining the views of young adult women. The intervention content aligns with a conceptual framework and includes messaging with the following themes: 1) Risks of breast cancer from alcohol consumption; 2) Efficacy content promoting behavior change; 3) Relevance to young adult women; 4) Mechanisms through which alcohol consumption increases breast cancer risk; 5) Exposing the alcohol industry's deceptive marketing practices; 6) Comparisons to other behavioral risk factors for cancer.
Participants in the control arm will receive text only content about skin cancer risk and prevention. This is based on intervention trials in other cancer prevention areas (e.g., tobacco) where the investigators used this type of control, provides a contact-matched comparison relative to the intervention arm, and ensures consistency of the protocol (e.g., timing of completion and content of measures to be completed) across the trial arms.
Alcohol Consumption
Alcohol consumption will be measured using the Timeline Follow Back, a valid self-report measure of daily alcohol consumption over the past 4 weeks. The Timeline Follow Back captures alcohol consumed each day in the past 4 weeks. The measure is administered at the end of the intervention, 4 weeks post intervention, and 12 weeks post intervention. Lower alcohol consumption is considered a better outcome.
Time frame: 12 weeks post intervention
Daily Alcohol Consumption
Daily alcohol consumption will be measured using Ecological Momentary Assessments, brief daily questions sent to participants' mobile phones that participants answer about whether they drank alcohol and, if so, how much. Daily assessment periods capture alcohol consumption from the end of the intervention to 4 weeks post-intervention, and from 8 weeks to 12 weeks post intervention. Lower daily alcohol consumption is considered a better outcome.
Time frame: 12 weeks post intervention
Intentions to Reduce Alcohol Consumption
Intentions to reduce alcohol consumption will be measured with two valid self-report items on a 1-4 scale. The items are averaged to create an overall score. Higher intentions to reduce alcohol consumption is considered a better outcome. The measure is administered at the end of the intervention, 4 weeks post intervention, and 12 weeks post intervention.
Time frame: 12 weeks post intervention
Alcohol and Breast Cancer Risk Beliefs
Alcohol and breast cancer risk beliefs will be measured using 2 valid self-report items on a 1 to 7 scale. Items will assess perceived risk of breast cancer from drinking alcohol and worry about the harm of breast cancer from drinking alcohol. The items are averaged to create an overall score. Higher risk beliefs are considered a better outcome. The measure is administered at the end of the intervention, 4 weeks post intervention, and 12 weeks post intervention.
Time frame: 12 weeks post intervention
Alcohol and Breast Cancer Efficacy Beliefs
Alcohol and breast cancer efficacy beliefs will be measured using 2 valid self-report items on a 1 to 7 scale. Items will assess confidence that reducing drinking can lower breast cancer risks and perceived reduction in breast cancer risk from reducing drinking. The items are averaged to create an overall score. Higher efficacy beliefs are considered a better outcome. The measure is administered at the end of the intervention, 4 weeks post intervention, and 12 weeks post intervention.
Time frame: 12 weeks post intervention
Awareness of the Risks of Breast Cancer from Drinking Alcohol
Awareness of the breast cancer risks from drinking alcohol will be measured using a single valid self-report item on a 1 to 5 scale. The item measures agreement or disagreement that drinking alcohol increases the risk of breast cancer. Higher values are considered better outcomes. The measure is administered at the end of the intervention, 4 weeks post intervention, and 12 weeks post intervention.
Time frame: 12 weeks post intervention
Transdermal Alcohol Concentration
Transdermal alcohol concentration will be measured with wearable biosensors in a subsample of up to 10% of participants. The biosensors capture drinking days confirmed by transdermal alcohol consumption. Fewer drinking days are considered a better outcome. Participants will wear biosensors consumption from the end of the intervention to 4 weeks post-intervention, and from 8 weeks to 12 weeks post intervention.
Time frame: 12 weeks post intervention
Plan to share: Yes — De-identified individual participant data from self-report measures and transdermal alcohol concentration biosensors will be deposited in the Inter-university Consortium for Political and Social Research (ICPSR). ICPSR will make the research data from this project available to the broader social science research community as public-use data files. These files, in which direct and indirect identifiers have been removed to minimize disclosure risk, may be accessed directly through the ICPSR website.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: The research data from this project will be supplied to ICPSR at the time of publication of the relevant results or at the end of the project period on July 1, 2027, whichever is sooner, so that any issues surrounding the usability of the data can be resolved. Data files will be permanently findable and identifiable (no end date) by assignment of a persistent unique identifier (a DOI) upon their availability in the repository. Delayed dissemination may be possible. The Delayed Dissemination Policy allows for data to be deposited but not disseminated for an agreed-upon period (typically one year).
Access criteria: After agreeing to Terms of Use, users with an ICPSR MyData account and an authorized IP address from a member institution may download the data, and non-members may purchase the files.
Started Mar 2026 (actual). Primary completion is estimated for Jul 2027, 15 months after the start.
Of 65 non-industry interventional studies with no phase under Risk-Taking, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 48. This study's planned 15 months is below that.
Counting every sponsor, half of 68 studies reached it within 28 months; a quarter within 7 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
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