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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2023-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Health Knowledge, Attitudes, Practice Alcohol Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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Brief alcohol intervention (Health4Her-Automated) + lifestyle health promotion

The intervention arm will receive:

* brief alcohol intervention
* lifestyle health promotion focused on physical activity and maintaining a healthy weight for reducing breast cancer risk.

Participants will receive an iPad and earphones to self-complete the intervention. Alcohol and lifestyle information will be delivered by way of an animation on an iPad, and self-completed activities to reinforce intervention content.

Group Type EXPERIMENTAL

Brief alcohol intervention (Health4Her-Automated)

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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).

Lifestyle health promotion

The control arm will receive:

* lifestyle health promotion focused on physical activity and maintaining a healthy weight for reducing breast cancer risk.

Participants will receive an iPad and earphones to self-complete the control intervention. Lifestyle information will be delivered by way of an animation on an iPad, and a self-completed activity to reinforce intervention content.

Group Type OTHER

Lifestyle health promotion

Intervention Type BEHAVIORAL

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).

Interventions

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Brief 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).

Intervention Type BEHAVIORAL

Lifestyle health promotion

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes