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

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT07799467
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Sep 2, 2026
Start date
Oct 15, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: 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.

Primary Outcome Measure

Recruitment Rate [ Time Frame: During the recruitment period ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Don Soffer clinical research centerMiamiFlorida33136
Maria Fernanda Garcia, BS
[email protected]
561-569-7987
Taghrid Asfar, MD,MSPH (PRINCIPAL_INVESTIGATOR)

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By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Don Soffer clinical research center· Miami, FL

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