Alcohol Counter Marketing as a Breast Cancer Prevention Strategy in Young Women
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Alcohol Consumption
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Alcohol and Breast Cancer Risk Messages (Behavioral)
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.
干预措施: Skin Cancer Risk Messages (Behavioral)
结局指标
主要结局
Alcohol Consumption
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Darren Mays
Professor
Ohio State University Comprehensive Cancer Center