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

Sponsor
Turning Point (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06019442
Collaborator
Monash University (Other), Eastern Health (Other), BreastScreen Victoria (Other), Lifepool (Other), Shades of Pink (Other)
90
1
2
2
44.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Brief alcohol intervention (Health4Her-Automated)
  • Behavioral: Lifestyle health promotion
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Other
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
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Drinking intentions [immediately post-randomisation]

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

Secondary Outcome Measures

  1. Drinking intentions [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 [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 [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 [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 [4-weeks post-randomisation]

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

  6. Alcohol literacy [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 [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 [4-weeks post-randomisation]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Maroondah BreastScreen Ringwood East Victoria Australia 3135

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Jasmin Grigg, PhD, Turning Point, Eastern Health; Monash University

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Turning Point
ClinicalTrials.gov Identifier:
NCT06019442
Other Study ID Numbers:
  • LR22-071-91112
First Posted:
Aug 31, 2023
Last Update Posted:
Sep 5, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Turning Point
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 5, 2023