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An Electronic Brief Alcohol Intervention for Women Attending a Breast Screening Service (Health4Her)

An Electronic Brief Intervention to Reduce Alcohol Consumption Intentions, Improve Alcohol Literacy, and Reduce Harmful Use Among Women Attending a Breast Screening Service: a Randomised Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06019442
Enrollment
143
Registered
2023-08-31
Start date
2023-09-01
Completion date
2023-12-01
Last updated
2024-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Knowledge, Attitudes, Practice, Alcohol Drinking

Keywords

Women's health, Public health, Health promotion

Brief summary

Alcohol is a major modifiable risk factor for female breast cancer; yet, awareness of this risk remains surprisingly low and is not systematically addressed in healthcare settings. This study aim to test the effectiveness of a co-designed, automated brief alcohol intervention (Health4Her-Automated) in reducing women's drinking intentions, improving alcohol literacy, and reducing consumption.

Detailed description

Alcohol is a major modifiable risk factor for female breast cancer, even in very low amounts. In Australia, alcohol consumption accounts for 6.6 per cent of cases in post-menopausal women, and 18 per cent of breast cancer deaths. Yet, awareness of this risk remains low and is not systematically addressed in healthcare settings. Embedding a brief alcohol intervention within lifestyle information offered to all women attending breast screening provides the opportunity to address harmful drinking in a discrete, non-judgmental way, to prevent alcohol-attributable breast cancer among this at-risk population. Brief alcohol interventions are short, single-session programs typically offered in general practice settings to gather information on a person's alcohol consumption and, in a non confrontational way, provide strategies and motivate change to reduce consumption and related risk of harm. An automated brief alcohol intervention, self-completed on a device such as an iPad, is a low-cost, labour- and time-efficient approach that overcomes many of the issues of providing intervention within busy healthcare environments. Building on the previous pilot trial of a prototype brief e-health intervention (which included alcohol-related questions asked by a researcher, and an animation viewed on an iPad that was activated by the researcher), the aim of the current study is to test the effectiveness of a co-designed, automated brief alcohol intervention (Health4Her-Automated) in reducing women's drinking intentions, improving alcohol literacy, and reducing consumption.

Interventions

BEHAVIORALBrief alcohol intervention (Health4Her-Automated)

Embedded within the lifestyle health promotion provided in both conditions, participants randomised to the experimental condition will receive a brief alcohol intervention. The brief alcohol intervention will comprise information and behaviour-change content regarding alcohol consumption, including: messaging around alcohol risks/harms (with a focus on alcohol use and breast cancer risk), positive-framed messaging on the health benefits of reducing alcohol intake, and alcohol harm-reduction / behaviour change strategies (e.g. drink counting, goal setting, behaviour substitution, problem solving). Post-session information will be provided via email (i.e. electronic brochure summarising brief alcohol intervention content).

Lifestyle health promotion, focused on physical activity and maintaining a healthy weight for reducing breast cancer risk, will be provided. Post-session information will be provided via email (i.e. electronic brochure summarising nutrition for maintaining a healthy weight).

Sponsors

Monash University
CollaboratorOTHER
Eastern Health
CollaboratorOTHER
BreastScreen Victoria
CollaboratorUNKNOWN
Lifepool
CollaboratorUNKNOWN
Shades of Pink
CollaboratorUNKNOWN
Turning Point
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The on-site researcher responsible for recruitment will not be blind to treatment assignment; the participating women self-completing baseline assessment, intervention, immediate post-intervention and 4-week follow-up assessments will be blinded to treatment assignment. The researcher who oversees follow-up assessment data collection will be blinded to treatment assignment.

Intervention model description

Randomised controlled trial (2 arms) + pilot of modified active arm The pilot group does not form part of the planned randomised controlled trial or power and sample size calculation, but is included based on findings from the previous phase of this research (e.g. women not having time to complete the intervention onsite). Therefore n\ 20 women who cannot participate on the day of breast screening will be offered to participate in the modified active arm offsite.

Eligibility

Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Female * 40+ years of age * Attending routine breast screening * With or without a breast cancer history * Reporting any level of alcohol consumption

Exclusion criteria

* Not able to read or comprehend English to enable participation * No access to a computer, tablet or smartphone to complete follow-up assessment * Women who are pregnant (also an exclusion from breast screening) * Participation in the pilot Health4Her trial

Design outcomes

Primary

MeasureTime frameDescription
Drinking intentionsimmediately post-randomisationChange in next-month drinking intentions (5-point scale: 1, not at all; 5, to a very large extent)

Secondary

MeasureTime frameDescription
Drinking intentions - standard drinks4-weeks post-randomisationChange in intended number of standard drinks consumed over the next month (composite of intention frequency/quantity response items)
Proportion of participants intending to reduce alcohol consumptionimmediately post-randomisationProportion of participants intending to reduce their next-month alcohol consumption (5-point scale: 1, not at all; 5, to a very large extent)
Knowledge of alcohol as a breast cancer risk factor4-weeks post-randomisationProportion of participants accurately identifying alcohol as a clear risk factor for breast cancer
Drinking intentions4-weeks post-randomisationChange in next-month drinking intentions (5-point scale: 1, not at all; 5, to a very large extent)
Alcohol consumption4-weeks post-randomisationAmong women who have had an alcohol drink in the past month, change in alcohol consumption (composite of frequency/quantity response items)
Knowledge of other breast cancer risk factors4-weeks post-randomisationProportion of participants accurately identifying inactivity and excess weight as risk factors for breast cancer
Alcohol literacy4-weeks post-randomisationProportion of participants accurately identifying i) the increased breast cancer risk associated with drinking one average restaurant serve of wine a day; ii) the number of standard drinks in an average restaurant serve of red wine; iii) the maximum number of standard drinks per week recommended by current Australian Alcohol Guidelines (multiple-choice questions)

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026