Sobriety Digital Intervention for Alcohol-Related Breast Cancer Risk

TA
MF
Overseen ByMaria Fernanda Garcia, BS
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Miami
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a digital tool called the Sobriety Digital Intervention, designed to help women understand how alcohol use can affect breast cancer risk. The study evaluates the tool's ease of use, engagement, and its impact on knowledge and behaviors related to alcohol. Women who regularly drink, attend breast cancer screenings, and own a smartphone or computer may be suitable participants. They will use the digital tool for four weeks and provide feedback on their experience and any changes in their alcohol habits. As an unphased trial, this study offers a unique opportunity to contribute to research that could lead to better health tools for women.

What prior data suggests that this digital intervention is safe?

Research has shown that digital tools for reducing alcohol consumption are generally safe. Studies suggest these tools can help people drink less without major safety concerns. Although specific information about the Sobriety Digital Intervention is limited, similar digital platforms are usually well-received. Users often report no harmful effects, making digital interventions a promising option for those seeking to manage their alcohol intake safely.12345

Why are researchers excited about this trial?

The Sobriety Digital Intervention is unique because it leverages digital technology to help reduce alcohol-related breast cancer risk. Unlike traditional methods that may involve face-to-face counseling or medication, this intervention provides a digital platform that participants can access for four weeks, making it convenient and accessible. Researchers are excited about this approach because it offers a novel way to engage individuals in behavioral change without the need for frequent in-person visits, potentially increasing adherence and effectiveness. Additionally, the digital format allows for personalized and flexible support, which could lead to more sustainable lifestyle changes and better outcomes.

What evidence suggests that the Sobriety Digital Intervention is effective for increasing awareness of alcohol-related breast cancer risk?

Research has shown that digital tools can help people reduce alcohol consumption, which is linked to a higher risk of breast cancer. Studies have found that users of these tools often decrease their drinking over time. For instance, one study found that heavy drinking days decreased by about 16% after using a digital tool. Reducing alcohol intake is crucial because even small amounts can increase breast cancer risk. In this trial, participants will receive the Sobriety Digital Intervention, designed to raise awareness and encourage habit changes, potentially lowering this risk.45678

Who Is on the Research Team?

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Taghrid Asfar, MD,MSPH

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for women aged 40 or older who are attending routine breast cancer screening visits. Participants should be able to use a digital platform and complete study assessments.

Inclusion Criteria

Regular alcohol users
Fluent in English
I am a woman attending my screening visit.
See 6 more

Exclusion Criteria

Prior participation in Stage 1 or Stage 2
Does not own a smartphone, iPad, or computer
I am currently undergoing cancer treatment.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

During routine screening visits
1 visit (in-person)

Intervention

Participants receive the Sobriety digital behavioral intervention during the clinic visit and maintain access to the platform for 4 weeks

4 weeks
1 visit (in-person), continued access to platform

Follow-up

Participants are monitored for feasibility, acceptability, engagement, and changes in alcohol-related knowledge and behavior

3 months
Assessments at 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Sobriety Digital Intervention

Trial Overview

The study tests a digital program called Sobriety, which aims to raise awareness about how alcohol use can increase breast cancer risk. All participants receive the intervention during their clinic visit and have access for four weeks.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Single-Cohort Feasibility TrialExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

Citations

Implementing a Digital Alcohol Intervention to Raise ...

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Across all three groups, the percentage of heavy drinking days decreased from 38.4% at baseline to 22.5% at 12-month follow up. There was no difference on the ...

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Alcohol and Breast Cancer Risk

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Alcohol and breast cancer risk: Middle-aged women's logic ...

We identified a low level of awareness of alcohol and breast cancer risk, and confusion related to alcohol as a risk for breast cancer, but not ...

The Latest Research on Alcohol & Breast Cancer

“Almost all studies find that women who drink at least a drink per day, or maybe a little bit less, have an increased risk of breast cancer,” ...

Alcohol and breast cancer risk: What to know

Per the Surgeon General Advisory, women who drink less than one alcoholic beverage per week have about an 11.3% risk of breast cancer in their ...