Alcohol Drinking, Breast Cancer
Conditions
Brief summary
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.
Interventions
BEHAVIORALSobriety Digital Intervention
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.
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | 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 | 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 | 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 | 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 | 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. |
Countries
United States
Contacts
CONTACTTaghrid Asfar, MD,MSPH
CONTACTMaria Fernanda Garcia, BS
PRINCIPAL_INVESTIGATORTaghrid Asfar, MD,MSPH
University of Miami
Outcome results
None listed