Behavior, RiskB-TrackNCT07320664
Breast Cancer Study Tracking Risk Awareness of Alcohol Consumption and Improving Knowledge in Young Adult Women
A study testing Alcohol and Breast Cancer Risk Messages and Skin Cancer Risk Messages in people with Behavior, Risk, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Behavior, Risk
- What is being tested?
- Alcohol and Breast Cancer Risk Messages and Skin Cancer Risk Messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2026to 1 Jul 2027
- 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 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 10Show fewer
- Able to complete procedures a, b, or c:
- Can read, write, and converse in English.
- Has a personal mobile smartphone with texting capabilities to receive text messages that may contain text and images.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Center contact
United States1 site, 1 recruiting
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Darren Mays, MPH, PhD, 614-366-2953, Darren.Mays@osumc.edu
Darren Mays, MPH, PhD
About this study
Official title: Alcohol Counter Marketing as a Breast Cancer Prevention Strategy in Young Women
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.
Read the detailed description
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.
- Conditions
- Behavior, Risk
- Being tested
- Alcohol and Breast Cancer Risk Messages, Skin Cancer Risk Messages
- Keywords
- cancer control, cancer prevention, alcohol
- Medical subject headings
- Risk-Taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol and Breast Cancer Risk MessagesBehavioural
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.
Skin Cancer Risk MessagesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Co-created Messages | Experimental | 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. Receives: Behavioral: Alcohol and Breast Cancer Risk Messages |
| Control | Other | 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. Receives: Behavioral: Skin Cancer Risk Messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start19 Mar 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior, RiskStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Responsible party
- Principal investigator, Darren Mays, Ohio State University Comprehensive Cancer Center
- Investigators
- Darren Mays, MPH, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320664
- Sponsor's protocol ID
- OSU-25089
- Other IDs
- PPI-23-007
- Acronym
- B-Track
- Status last verified
- Mar 2026
- First submitted
- 18 Dec 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Counter Marketing as a Breast Cancer Prevention Strategy in Young Women
- ClinicalTrials.gov ID
- NCT07320664
- Acronym / sponsor ID
- B-Track / OSU-25089
- Conditions
- Behavior, Risk
- Keywords
- cancer control, cancer prevention, alcohol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 6 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Co-created Messages | Experimental | Behavioral: Alcohol and Breast Cancer Risk MessagesParticipants 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. |
| Control | Other | Behavioral: Skin Cancer Risk MessagesParticipants 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Alcohol and Breast Cancer Risk MessagesParticipants 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. | Behavioural | Co-created Messages |
| Skin Cancer Risk MessagesParticipants 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. | Behavioural | Control |
Primary outcome
Alcohol Consumption
Time frame: 12 weeks post intervention
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.
Daily Alcohol Consumption
Time frame: 12 weeks post intervention
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.
Intentions to Reduce Alcohol Consumption
Time frame: 12 weeks post intervention
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.
Alcohol and Breast Cancer Risk Beliefs
Time frame: 12 weeks post intervention
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.
Alcohol and Breast Cancer Efficacy Beliefs
Time frame: 12 weeks post intervention
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.
Awareness of the Risks of Breast Cancer from Drinking Alcohol
Time frame: 12 weeks post intervention
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.
Transdermal Alcohol Concentration
Time frame: 12 weeks post intervention
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.
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 25 Mar 2026.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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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.
The Ohio State University Comprehensive Cancer Center contact
Darren Mays, MPH, PhD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol and Breast Cancer Risk Messages and Skin Cancer Risk Messages in people with Behavior, Risk, run by Ohio State University Comprehensive Cancer Center 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 10 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 25 Mar 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?
Contact The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Consumption (time frame: 12 weeks post intervention). The study lists 7 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 25 Mar 2026.