Implementing a Digital Alcohol Intervention to Raise Women's Awareness of Alcohol-related Breast Cancer Risk During Routine Screening Visits
2026年9月1日 更新者：Taghrid Asfar、University of Miami
This study is a single-arm feasibility trial evaluating a digital behavioral intervention designed to increase women's awareness of the relationship between alcohol use and breast cancer risk during routine breast cancer screening visits.
The study will enroll 36 women aged 40 years or older.
Participants will complete baseline measures and receive the Sobriety digital intervention during the clinic visit, followed by 4 weeks of continued access to the platform.
Assessments will be completed immediately after the intervention and at 3 months to evaluate feasibility, acceptability, engagement, and changes in alcohol-related knowledge and behavior.
研究概览
研究类型
介入性
注册 (估计的)
36
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Taghrid Asfar, MD,MSPH
- 电话号码：305-243-3826
- 邮箱：tasfar@med.miami.edu
研究联系人备份
- 姓名：Maria Fernanda Garcia, BS
- 电话号码：561-569-7987
- 邮箱：mfg136@miami.edu
学习地点
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Florida
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Miami、Florida、美国、33136
- Don Soffer clinical research center
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接触：
- Maria Fernanda Garcia, BS
- 电话号码：561-569-7987
- 邮箱：mfg136@miami.edu
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首席研究员：
- Taghrid Asfar, MD,MSPH
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Women attending their screening visit
- Regular alcohol users
- Aged 40+ years
- Fluent in English
- With or without cancer
- Not currently receiving cancer treatment
- Own a smartphone, iPad, or computer
- Able to provide consent
- Must not have participated in Stage 1 or Stage 2.
Exclusion Criteria:
- Younger than 40 years
- Non-English speaking
- Unable to provide informed consent
- Does not own a smartphone, iPad, or computer
- Currently receiving cancer treatment
- Prior participation in Stage 1 or Stage 2.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Single-Cohort Feasibility Trial
Participants will undergo a routine standard-of-care breast cancer screening visit and receive the Sobriety digital behavioral intervention.
Participants will maintain access to the digital intervention platform for 4 weeks following the screening visit.
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Participants will receive a digital behavioral intervention that includes alcohol use screening, personalized feedback, education on alcohol-related breast cancer risk, brief motivational content, and goal-setting exercises.
Participants will retain access to the intervention platform for 4 weeks following the initial intervention.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Recruitment Rate
大体时间：During the recruitment period
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Percentage of eligible participants approached for participation who provide informed consent and enroll in the study.
Recruitment feasibility will be considered achieved if at least 70% of eligible participants approached enroll in the study.
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During the recruitment period
|
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Retention Rate
大体时间：3-month follow-up
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Percentage of enrolled participants who complete the 3-month follow-up assessment.
Retention feasibility will be considered achieved if at least 75% of enrolled participants complete the 3-month follow-up assessment.
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3-month follow-up
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Intervention Completion
大体时间：Over the 3-month intervention period
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Percentage of enrolled participants who complete all core intervention modules.
Intervention feasibility will be considered achieved if at least 70% of enrolled participants complete the core intervention modules.
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Over the 3-month intervention period
|
|
System Usability Scale (SUS) Score
大体时间：3-month follow-up
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Participant-reported usability of the intervention as assessed using the System Usability Scale (SUS), a 10-item questionnaire with total scores ranging from 0 to 100.
Higher scores indicate greater perceived usability.
Acceptability will be considered satisfactory if the mean SUS score is at least 70.
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3-month follow-up
|
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Participants Rating the Intervention as Helpful or Very Helpful
大体时间：3-month follow-up
|
Percentage of participants who rate the intervention as "helpful" or "very helpful" on a participant satisfaction assessment.
Acceptability will be considered satisfactory if at least 80% of participants rate the intervention as helpful or very helpful.
|
3-month follow-up
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Taghrid Asfar, MD,MSPH、University of Miami
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月15日
初级完成 (估计的)
2026年12月1日
研究完成 (估计的)
2027年3月1日
研究注册日期
首次提交
2026年8月25日
首先提交符合 QC 标准的
2026年9月1日
首次发布 (实际的)
2026年9月2日
研究记录更新
最后更新发布 (实际的)
2026年9月2日
上次提交的符合 QC 标准的更新
2026年9月1日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.