Recruiting

Breast Cancer Awareness

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT07320664

Conditions

Behavior, Risk

Eligibility Criteria

Sex: Female

Age: 18 - 25

Healthy Volunteers: Accepted

Interventions

Alcohol and Breast Cancer Risk Messages

Skin Cancer Risk Messages

Study Details

Brief 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.

Conditions

Behavior, Risk

Study ID

NCT07320664

Start date

Mar 19, 2026

Status verified date

Mar, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 25

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Co-created Messages

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.

other: Control

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.

Interventions

Alcohol and Breast 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.

Skin Cancer Risk Messages

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.

Primary outcome measure

  • Alcohol Consumption [ Time Frame: 12 weeks post intervention ]
  • Daily Alcohol Consumption [ Time Frame: 12 weeks post intervention ]
  • Intentions to Reduce Alcohol Consumption [ Time Frame: 12 weeks post intervention ]
  • Alcohol and Breast Cancer Risk Beliefs [ Time Frame: 12 weeks post intervention ]
  • Alcohol and Breast Cancer Efficacy Beliefs [ Time Frame: 12 weeks post intervention ]
  • Awareness of the Risks of Breast Cancer from Drinking Alcohol [ Time Frame: 12 weeks post intervention ]
  • Transdermal Alcohol Concentration [ Time Frame: 12 weeks post intervention ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Darren Mays, MPH, PhD

614-366-2953Darren.Mays@osumc.edu

Principal Investigator:

Darren Mays, MPH, PhD

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Mar 25, 2026

Last verified

Mar, 2026

Keywords

  • cancer control
  • cancer prevention
  • alcohol

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-03-25.