Breast Cancer Study Tracking Risk Awareness of Alcohol Consumption and Improving Knowledge in Young Adult Women (B-Track)

The Ohio State University

Status: Not yet enrolling

Conditions: Behavior, Risk

Treatments: Behavioral: Skin Cancer Risk Messages; Behavioral: Alcohol and Breast Cancer Risk Messages

Study type: Interventional

Funder types: Other

Identifiers

NCT07320664

OSU-25089

PPI-23-007 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Co-created Messages

Experimental group

Description:

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.

Treatment:

Behavioral: Alcohol and Breast Cancer Risk Messages

Control

Other group

Description:

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.

Treatment:

Behavioral: Skin Cancer Risk Messages