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

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Drinking; Health Knowledge, Attitudes, Practice
• Intervention / Treatment: Behavioral: Brief alcohol intervention (Health4Her-Automated); Behavioral: Lifestyle health promotion

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.

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Ringwood East, Victoria, Australia, 3135
      • Maroondah BreastScreen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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).; 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).
Other: 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.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Turning Point
• Collaborators: Monash University; Eastern Health; BreastScreen Victoria; Lifepool; Shades of Pink
• Investigators: Principal Investigator: Jasmin Grigg, PhD, Turning Point, Eastern Health; Monash University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): October 6, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: August 13, 2023
• First Submitted That Met QC Criteria: August 29, 2023
• First Posted (Actual): August 31, 2023

Study Record Updates

• Last Update Posted (Actual): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Health promotion; Women's health; Public health
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: LR22-071-91112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not Ethics approval to seek patient permission to share data outside this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No