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Completed

NCT Number: NCT06019442

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

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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Key information

Conditions

Health Knowledge, Attitudes, Practice Alcohol Drinking Behavior Drinking Behavior

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maroondah BreastScreen

Ringwood East, Victoria, 3135, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Brief alcohol intervention (Health4Her-Automated)

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

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).

Primary outcomes

  1. Drinking intentions

    Time frame: immediately post-randomisation

    Change in next-month drinking intentions (5-point scale: 1, not at all; 5, to a very large extent)

Secondary outcomes

  1. Drinking intentions

    Time frame: 4-weeks post-randomisation

    Change in next-month drinking intentions (5-point scale: 1, not at all; 5, to a very large extent)

  2. Drinking intentions - standard drinks

    Time frame: 4-weeks post-randomisation

    Change in intended number of standard drinks consumed over the next month (composite of intention frequency/quantity response items)

  3. Proportion of participants intending to reduce alcohol consumption

    Time frame: immediately post-randomisation

    Proportion of participants intending to reduce their next-month alcohol consumption (5-point scale: 1, not at all; 5, to a very large extent)

  4. Proportion of participants intending to reduce alcohol consumption

    Time frame: 4-weeks post-randomisation

    Proportion of participants intending to reduce their next-month alcohol consumption (5-point scale: 1, not at all; 5, to a very large extent)

  5. Knowledge of alcohol as a breast cancer risk factor

    Time frame: 4-weeks post-randomisation

    Proportion of participants accurately identifying alcohol as a clear risk factor for breast cancer

  6. Alcohol literacy

    Time frame: 4-weeks post-randomisation

    Proportion 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)

  7. Alcohol consumption

    Time frame: 4-weeks post-randomisation

    Among women who have had an alcohol drink in the past month, change in alcohol consumption (composite of frequency/quantity response items)

  8. Knowledge of other breast cancer risk factors

    Time frame: 4-weeks post-randomisation

    Proportion of participants accurately identifying inactivity and excess weight as risk factors for breast cancer

Sponsors and collaborators

Lead sponsor

Turning Point

Other

Collaborators

  • BreastScreen Victoria
  • Eastern Health
  • Lifepool
  • Monash University
  • Shades of Pink

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 31, 2023
Registry last updated
Feb 9, 2024

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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