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NCT Number: NCT07799467

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

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.

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Key information

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Don Soffer clinical research center

Miami, Florida, 33136, United States

Location contact

Maria Fernanda Garcia, BS

CONTACT

[email protected]

561-569-7987

Taghrid Asfar, MD,MSPH

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Recruitment Rate

    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.

  2. Retention Rate

    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.

  3. Intervention Completion

    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.

  4. System Usability Scale (SUS) Score

    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.

  5. Participants Rating the Intervention as Helpful or Very Helpful

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Fernanda Garcia, BS

CONTACT

[email protected]

561-569-7987

Taghrid Asfar, MD,MSPH

CONTACT

[email protected]

305-243-3826

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

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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