Clinical trial NCT06019442: An Electronic Brief Alcohol Intervention for Women Attending a Breast Screening Service (Health4Her)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice
Alcohol Drinking
Keywords: Women's health
Public health
Health promotion
Lead sponsor: Turning Point
Sponsor class: OTHER
Collaborators: name: Monash University
name: Eastern Health
name: BreastScreen Victoria
name: Lifepool
name: Shades of Pink
First posted: 2023-08-31
Enrollment: 143
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Drinking intentions
timeFrame: immediately post-randomisation
Secondary outcomes:
measure: Drinking intentions
timeFrame: 4-weeks post-randomisation
measure: Drinking intentions - standard drinks
timeFrame: 4-weeks post-randomisation
measure: Proportion of participants intending to reduce alcohol consumption
timeFrame: immediately post-randomisation
measure: Proportion of participants intending to reduce alcohol consumption
timeFrame: 4-weeks post-randomisation
measure: Knowledge of alcohol as a breast cancer risk factor
timeFrame: 4-weeks post-randomisation
measure: Alcohol literacy
timeFrame: 4-weeks post-randomisation
measure: Alcohol consumption
timeFrame: 4-weeks post-randomisation
measure: Knowledge of other breast cancer risk factors
timeFrame: 4-weeks post-randomisation
Other outcomes:
Locations:
city: Ringwood East
country: Australia
facility: Maroondah BreastScreen
state: Victoria
Study officials:
affiliation: Turning Point, Eastern Health; Monash University
name: Jasmin Grigg, PhD
role: PRINCIPAL_INVESTIGATOR
References: