Implementing a Digital Alcohol Intervention to Raise Women's Awareness of Alcohol-related Breast Cancer Risk During Routine Screening Visits
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Recruitment Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Sobriety Digital Intervention (Behavioral)
结局指标
主要结局
Recruitment Rate
时间窗: During the recruitment period
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.
Retention Rate
时间窗: 3-month follow-up
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.
Intervention Completion
时间窗: Over the 3-month intervention period
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.
System Usability Scale (SUS) Score
时间窗: 3-month follow-up
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.
Participants Rating the Intervention as Helpful or Very Helpful
时间窗: 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.
次要结局
未报告次要终点
研究者
Taghrid Asfar
Professor
University of Miami