Breast CancerNCT07799467
Implementing a Digital Alcohol Intervention to Raise Women's Awareness of Alcohol-related Breast Cancer Risk During Routine Screening Visits
A study testing Sobriety Digital Intervention in people with Breast Cancer and Alcohol Drinking, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast Cancer, Alcohol Drinking
- What is being tested?
- Sobriety Digital Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2027to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women attending their screening visit
- Regular alcohol users
- Aged 40+ years
- Fluent in English
- With or without cancer
- Not currently receiving cancer treatment
Show all 9Show fewer
- Own a smartphone, iPad, or computer
- Able to provide consent
- Must not have participated in Stage 1 or Stage 2.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Don Soffer clinical research center
Miami, Florida, 33136
Maria Fernanda Garcia, BS, 561-569-7987, mfg136@miami.edu
Taghrid Asfar, MD,MSPH
About this study
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.
- Conditions
- Breast Cancer, Alcohol Drinking
- Being tested
- Sobriety Digital Intervention
- Medical subject headings
- Breast Neoplasms, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sobriety Digital InterventionBehavioural
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 group | Role | What they receive |
|---|---|---|
| Single-Cohort Feasibility Trial | Experimental | 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. Receives: Behavioral: Sobriety Digital Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the recruitment period
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.
Measured: 3-month follow-up
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.
Measured: Over the 3-month intervention period
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.
Measured: 3-month follow-up
Participants Rating the Intervention as Helpful or Very Helpful
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.
Measured: 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start4 Jan 2027 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taghrid Asfar, University of Miami
- Investigators
- Taghrid Asfar, MD,MSPH, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799467
- Sponsor's protocol ID
- 20251213
- Status last verified
- Oct 2026
- First submitted
- 25 Aug 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Digital Alcohol Intervention to Raise Women's Awareness of Alcohol-related Breast Cancer Risk During Routine Screening Visits
- ClinicalTrials.gov ID
- NCT07799467
- Acronym / sponsor ID
- 20251213
- Conditions
- Breast Cancer, Alcohol Drinking
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 4 Jan 2027 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Cohort Feasibility Trial | Experimental | Behavioral: Sobriety Digital InterventionParticipants 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Women attending their screening visit
- Regular alcohol users
- Aged 40+ years
- Fluent in English
- With or without cancer
Key exclusion criteria (6 listed)
- Younger than 40 years
- Non-English speaking
- Unable to provide informed consent
- Does not own a smartphone, iPad, or computer
- Currently receiving cancer treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sobriety Digital InterventionParticipants 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. | Behavioural | Single-Cohort Feasibility Trial |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Taghrid Asfar, MD,MSPH principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sobriety Digital Intervention in people with Breast Cancer and Alcohol Drinking, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taghrid Asfar, MD,MSPH (305-243-3826, tasfar@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: During the recruitment period). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.