Implementing a Digital Alcohol Intervention to Raise Women's Awareness of Alcohol-related Breast Cancer Risk During Routine Screening Visits

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40+
SponsorUniversity of Miami

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Sobriety Digital Intervention

    Behavioral

    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.

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: Single-Cohort Feasibility TrialExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
During the recruitment period
2

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.

Time frame
3-month follow-up
3

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.

Time frame
Over the 3-month intervention period
4

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.

Time frame
3-month follow-up

Secondary outcomes

Other outcomes

Sponsors and contacts

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