Breast Cancer Study Tracking Risk Awareness of Alcohol Consumption and Improving Knowledge in Young Adult Women

Официальное название

Alcohol Counter Marketing as a Breast Cancer Prevention Strategy in Young Women

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 include
• Поведенческое 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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:

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Ohio State University Comprehensive Cancer Center — Columbus

Идентификаторы

NCT: NCT07320664 · OSU-25089 · PPI-23-007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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