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

NCT06019442 | Completed

• 1 other identifier: LR22-071-91112
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Knowledge, Attitudes, Practice; Alcohol Drinking

Keywords

Women's health; Public health; Health promotion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Drinking intentions

  4-weeks post-randomisation

• Drinking intentions - standard drinks

  4-weeks post-randomisation

• Proportion of participants intending to reduce alcohol consumption

  immediately post-randomisation

• Proportion of participants intending to reduce alcohol consumption

  4-weeks post-randomisation

• Knowledge of alcohol as a breast cancer risk factor

  4-weeks post-randomisation

Study Arms (2)

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

EXPERIMENTAL

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); Behavioral: Lifestyle health promotion

Lifestyle health promotion

OTHER

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

Interventions

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).

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

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).

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

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• + years of age
• Attending routine breast screening
• With or without a breast cancer history
• Reporting any level of alcohol consumption

You may not qualify if:

• Not able to read or comprehend English to enable participation
• No access to a computer, tablet or smartphone to complete follow-up assessment
• Participation in the pilot Health4Her trial

Sponsors & Collaborators

• Turning Point: lead
• Monash University: collaborator
• Eastern Health: collaborator
• BreastScreen Victoria: collaborator
• Lifepool: collaborator
• Shades of Pink: collaborator

Study Sites (1)

Maroondah BreastScreen

Ringwood East, Victoria, 3135, Australia

Location

MeSH Terms

Conditions

Behavior; Alcohol Drinking

Interventions

Ethanol; Methods

Condition Hierarchy (Ancestors)

Drinking Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Investigative Techniques

Study Officials

• Jasmin Grigg, PhD

  Turning Point, Eastern Health; Monash University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 13, 2023
• First Posted: August 31, 2023
• Study Start: September 1, 2023
• Primary Completion: October 6, 2023
• Study Completion: December 1, 2023
• Last Updated: February 9, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)