About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women attending their screening visit
Regular alcohol users
Aged 40+ years
Fluent in English
Disqualifiers
Younger than 40 years
Non-English speaking
Unable to provide informed consent
Does not own a smartphone, iPad, or computer
Trial design
Single group
Treatments tested in this trial
Sobriety Digital Intervention
BehavioralParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Recruitment Rate
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
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
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
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: