Increasing Knowledge of Alcohol as a Risk Factor for Breast Cancer Among Women Attending Breast Screening Services

Study Overview
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Brief Summary
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Alcohol is a major modifiable risk factor for breast cancer in women, yet this is not widely understood by health practitioners or policy makers, let alone the general population. The investigators aim to test the effects of a targeted alcohol and lifestyle brief intervention for women attending breast screening services, to improve knowledge of alcohol as a risk factor for breast cancer and reduce harmful alcohol use.

Official Title
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A Brief Intervention to Increase Knowledge of Alcohol as a Breast Cancer Risk Factor Among Women Attending Breast Screening Services (Health4Her): A Pilot Randomised Controlled Trial

Conditions
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Health Knowledge, Attitudes, Practice, Alcohol Consumption

Intervention / Treatment
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* Behavioral: alcohol brief intervention
* Behavioral: lifestyle health promotion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female attending breast screening service for a routine mammography 40-74 years English as a first language or fluent regular access to a telephone able to provide informed consent to participate any level of alcohol consumption (including non-drinkers) Exclusion Criteria: hearing impairment sufficient to prohibit a telephone interview pregnancy not able to read or comprehend English to provide informed consent or receive the brief intervention

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: alcohol brief intervention + lifestyle health promotion<br>The intervention arm will receive 4 minutes of alcohol brief intervention, and 3 minutes of lifestyle health promotion (physical activity; maintaining a healthy weight), to increase knowledge of how to improve women's health and reduce breast cancer risk. Alcohol and lifestyle information will be delivered by way of an animation on an iPad. Participant responses to questions about current alcohol use will branch to personalised feedback consistent with level of alcohol consumption (i.e. drinking within or above current Australian Alcohol Guidelines). Take-home pamphlets - a pamphlet summarising the alcohol information presented during the animation, and a pamphlet on nutrition to maintain a healthy weight, will be provided. | Behavioral: alcohol brief intervention<br>* Nested within the lifestyle health promotion provided in both conditions, participants randomised to the experimental condition will receive an alcohol brief intervention. The strong evidence-base for alcohol brief intervention, amplified by Co-Investigators' Smith and Bragge's (BehaviourWorks) approaches to applied behaviour change, has provided the framework for the development of the alcohol brief intervention used in this study. This intervention comprises personalised feedback on alcohol consumption levels, comparison to gender/age drinking norms, and information and behaviour-change content regarding alcohol consumption (i.e. negative-framed messaging around alcohol risks and harms, positive-framed messaging on the health benefits of reducing alcohol intake, alcohol harm reduction strategies).<br>Behavioral: lifestyle health promotion<br>* Lifestyle health promotion specific to physical activity and maintaining a healthy weight, developed to be relevant to women attending breast screening services, will be provided.<br>|
| Other: lifestyle health promotion, not inclusive of alcohol information<br>The control arm will receive 3 minutes of lifestyle health promotion (physical activity; maintaining a healthy weight) to increase knowledge of how to improve women's health and reduce breast cancer risk, not inclusive of alcohol information. Lifestyle information will be delivered by way of an animation on an iPad. Take-home pamphlet - a pamphlet on nutrition to maintain a healthy weight will be provided. | Behavioral: lifestyle health promotion<br>* Lifestyle health promotion specific to physical activity and maintaining a healthy weight, developed to be relevant to women attending breast screening services, will be provided.<br>|

What is the study measuring?
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Primary 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drinking within current Australian Alcohol Guidelines | Proportion of participants drinking less than or equal to 10 standard drinks per week (within current Australian Alcohol Guidelines) (14-day Timeline Followback, TLFB) | 4-weeks and 3-months post-randomisation | 
| Drinking within current Australian Alcohol Guidelines (among participants who drink more than 10 standard drinks per week) | Among participants who drink more than 10 standard drinks per week at baseline: Proportion of participants drinking less than or equal to 10 standard drinks per week. (14-day TLFB) | 4-weeks and 3-months post-randomisation | 
| Alcohol consumption | Change in alcohol consumption (14-day TLFB; AIHW alcohol frequency quantity items) | 4-weeks and 3-months post-randomisation | 
| Alcohol consumption (among participants who drink more than 10 standard drinks per week) | Among participants who drink more than 10 standard drinks per week at baseline: Change in alcohol consumption (14-day TLFB; AIHW alcohol frequency quantity items) | 4-weeks and 3-months post-randomisation | 
| Health literacy - attitudes | Change in participants' attitudes regarding alcohol and breast cancer risk (5-point scale, strongly agree to strongly disagree; items adapted from previous literature, e.g. Fisher et al. 2017) | 4-weeks post-randomisation | 
| Health literacy - knowledge | Proportion of participants accurately identifying i) the amount of alcohol in an Australian standard drink; 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 and open-ended questions, adapted from previous literature, e.g. Bowden et al. 2014) | 4-weeks post-randomisation | 
| Health literacy - access to health information | Proportion of participants who have accessed health information on i) alcohol harms, ii) alcohol and breast cancer risk, and iii) alcohol harm-reduction | 4-weeks post-randomisation | 
| General health | Change in general health (SF-12) | 4-weeks and 3-months post-randomisation | 
| Quality of life | Change in quality of life (EUROHIS-QOL single item) | 4-weeks and 3-months post-randomisation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Women's health, Public Health, Health promotion/education