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

Primary Purpose

Health Knowledge, Attitudes, Practice, Alcohol Drinking

Status
Not yet recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Brief alcohol intervention (Health4Her-Automated)
Lifestyle health promotion
Sponsored by
Turning Point
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Health Knowledge, Attitudes, Practice focused on measuring Women's health, Public health, Health promotion

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Maroondah BreastScreen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

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

Lifestyle health promotion

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Drinking intentions
Change in next-month drinking intentions (5-point scale: 1, not at all; 5, to a very large extent)
Drinking intentions - standard drinks
Change in intended number of standard drinks consumed over the next month (composite of intention frequency/quantity response items)
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)
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)
Knowledge of alcohol as a breast cancer risk factor
Proportion of participants accurately identifying alcohol as a clear risk factor for breast cancer
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)
Alcohol consumption
Among women who have had an alcohol drink in the past month, change in alcohol consumption (composite of frequency/quantity response items)
Knowledge of other breast cancer risk factors
Proportion of participants accurately identifying inactivity and excess weight as risk factors for breast cancer

Full Information

First Posted
August 13, 2023
Last Updated
August 30, 2023
Sponsor
Turning Point
Collaborators
Monash University, Eastern Health, BreastScreen Victoria, Lifepool, Shades of Pink
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1. Study Identification

Unique Protocol Identification Number
NCT06019442
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turning Point
Collaborators
Monash University, Eastern Health, BreastScreen Victoria, Lifepool, Shades of Pink

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Knowledge, Attitudes, Practice, Alcohol Drinking
Keywords
Women's health, Public health, Health promotion

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brief alcohol intervention (Health4Her-Automated) + lifestyle health promotion
Arm Type
Experimental
Arm Description
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.
Arm Title
Lifestyle health promotion
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brief alcohol intervention (Health4Her-Automated)
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle health promotion
Intervention Description
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).
Primary Outcome Measure Information:
Title
Drinking intentions
Description
Change in next-month drinking intentions (5-point scale: 1, not at all; 5, to a very large extent)
Time Frame
immediately post-randomisation
Secondary Outcome Measure Information:
Title
Drinking intentions
Description
Change in next-month drinking intentions (5-point scale: 1, not at all; 5, to a very large extent)
Time Frame
4-weeks post-randomisation
Title
Drinking intentions - standard drinks
Description
Change in intended number of standard drinks consumed over the next month (composite of intention frequency/quantity response items)
Time Frame
4-weeks post-randomisation
Title
Proportion of participants intending to reduce alcohol consumption
Description
Proportion of participants intending to reduce their next-month alcohol consumption (5-point scale: 1, not at all; 5, to a very large extent)
Time Frame
immediately post-randomisation
Title
Proportion of participants intending to reduce alcohol consumption
Description
Proportion of participants intending to reduce their next-month alcohol consumption (5-point scale: 1, not at all; 5, to a very large extent)
Time Frame
4-weeks post-randomisation
Title
Knowledge of alcohol as a breast cancer risk factor
Description
Proportion of participants accurately identifying alcohol as a clear risk factor for breast cancer
Time Frame
4-weeks post-randomisation
Title
Alcohol literacy
Description
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)
Time Frame
4-weeks post-randomisation
Title
Alcohol consumption
Description
Among women who have had an alcohol drink in the past month, change in alcohol consumption (composite of frequency/quantity response items)
Time Frame
4-weeks post-randomisation
Title
Knowledge of other breast cancer risk factors
Description
Proportion of participants accurately identifying inactivity and excess weight as risk factors for breast cancer
Time Frame
4-weeks post-randomisation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jasmin Grigg, PhD
Phone
+61 3 8413 8723
Email
jasmin.grigg@monash.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dan I Lubman, PhD
Phone
+61 3 8413 8413
Email
dan.lubman@monash.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jasmin Grigg, PhD
Organizational Affiliation
Turning Point, Eastern Health; Monash University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maroondah BreastScreen
City
Ringwood East
State/Province
Victoria
ZIP/Postal Code
3135
Country
Australia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darren Lockie, FRANZCR
Email
dlockie@breastscreen.org.au

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not Ethics approval to seek patient permission to share data outside this study.

Learn more about this trial

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

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