Don Soffer clinical research center
Miami, Florida, 33136, United States
Location contact
Maria Fernanda Garcia, BS
CONTACT
Taghrid Asfar, MD,MSPH
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07799467
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.
Trial opening soon.
Get Notified40 year and older
Female
Interventional
Not applicable
Miami, Florida, 33136, United States
Maria Fernanda Garcia, BS
CONTACT
Taghrid Asfar, MD,MSPH
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Maria Fernanda Garcia, BS
CONTACT
Taghrid Asfar, MD,MSPH
CONTACT
University of Miami
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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