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

Alcohol Drinking Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06019442
• Other study ID #: LR22-071-91112
• Status: Completed
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: December 2023
• Source: Turning Point
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: December 1, 2023
• Est. primary completion date: October 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Health Knowledge, Attitudes, Practice

Intervention

Behavioral:
• 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).
• 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).

Locations

Country	Name	City	State
Australia	Maroondah BreastScreen	Ringwood East	Victoria

Sponsors (6)

Lead Sponsor	Collaborator
Turning Point	BreastScreen Victoria, Eastern Health, Lifepool, Monash University, Shades of Pink

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drinking intentions	Change in next-month drinking intentions (5-point scale: 1, not at all; 5, to a very large extent)	immediately post-randomisation
Secondary	Drinking intentions	Change in next-month drinking intentions (5-point scale: 1, not at all; 5, to a very large extent)	4-weeks post-randomisation
Secondary	Drinking intentions - standard drinks	Change in intended number of standard drinks consumed over the next month (composite of intention frequency/quantity response items)	4-weeks post-randomisation
Secondary	Proportion of participants intending to reduce alcohol consumption	Proportion of participants intending to reduce their next-month alcohol consumption (5-point scale: 1, not at all; 5, to a very large extent)	immediately post-randomisation
Secondary	Proportion of participants intending to reduce alcohol consumption	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-weeks post-randomisation
Secondary	Knowledge of alcohol as a breast cancer risk factor	Proportion of participants accurately identifying alcohol as a clear risk factor for breast cancer	4-weeks post-randomisation
Secondary	Alcohol literacy	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)	4-weeks post-randomisation
Secondary	Alcohol consumption	Among women who have had an alcohol drink in the past month, change in alcohol consumption (composite of frequency/quantity response items)	4-weeks post-randomisation
Secondary	Knowledge of other breast cancer risk factors	Proportion of participants accurately identifying inactivity and excess weight as risk factors for breast cancer	4-weeks post-randomisation