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
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice, Alcohol Consumption
Sponsor: Turning Point

 
 
 
Study Name: Alcohol Breast Screening Project 
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PROTOCOL  
 
Health4Her: Increasing knowledge of alcohol as a risk factor for 
breast cancer among women attending breast screening services 
 
Clinicaltrials.gov Registration Number: NCT04715516  
Protocol Version # and date: Version 7, 8th August 2021  
 
Revision Chronology: 
Date of change 
 
Summary of changes 
1st February 2019 
Version 1: original document 
16th July 2019 
Version 2: update to section 5.3 Recruitment and identification of potential participants, addition 
of researcher script, conduct formative evaluation focus groups/surveys with Lifepool, 
clarification of subsample to complete alcohol consumption/intervention feasibility questions, 
increase number of participants to power the pilot trial (update power and sample size 
calculation), refine aims, update alcohol items, add protocol for providing contact details for 
additional support as required, add implied consent via use of a iPAD landing page, add VicHealth 
funder, update title, update timeline. 
29th July 2019 
Version 3: references to PICF in sections 8.1 and 8.2 changed to refer to Participant Information 
Sheet (PIS; consent provided via iPAD landing page) 
27th August 2019 
Version 4: Addition of donation to breast cancer research for pre-trial feasibility survey / focus 
group participation 
19th January 2021 
Version 5: refined study outcomes and measures. Updated power and sample size calculation, 
and data analysis plan. Minor changes to inclusion/exclusion criteria. Refined title and description 
of the intervention. Added verbal consent procedure to replace iPad landing consent page. Added 
Eastern Health COVID-19 safety procedures at Maroondah BreastScreen. Updated project 
timeline. 
12th May 2020 
Version 6: introduced potential for participants to provide written consent when recruitment is 
busy. Added process whereby Maroondah BreastScreen reception provide a reminder text 
message or phone call prior to recruitment days and flag the study occurring onsite. 
8th August 2020 
Version 7: Minor changes to protocol based on trial procedures in practice; updated description 
of data collection to more accurately reflect functionality of REDCap and use/security of 
identifiable and re-identifiable data.  
 
Sponsor 
Eastern Health 
 
Funded By 
2019 Easter Health Foundation Research and Innovation Grant 
2019 VicHealth Impact Research Grant 
 
Statement of Compliance 
This document is a protocol for a research project. This study will be conducted in compliance with 
all stipulation of this protocol, the conditions of the ethics committee approval, the NHMRC National 
Statement on Ethical Conduct in Human Research (2007) and the Note for Guidance on Good Clinical 
Practice (CPMP/ICH-135/95). 

 
 
 
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CONTENTS 
PROTOCOL SYNOPSIS ............................................................................................................................... 5 
1 
ADMINISTRATIVE INFORMATION ..................................................................................................... 7 
1.1. 
Trial registration ........................................................................................................................... 7 
1.2. 
Expected duration of study .......................................................................................................... 7 
1.3. 
Contributorship ............................................................................................................................ 8 
2 
INTRODUCTION AND BACKGROUND................................................................................................ 8 
3 
STUDY OBJECTIVES ........................................................................................................................... 9 
3.1 
Primary aim and hypothesis ......................................................................................................... 9 
3.2 
Secondary aims and hypotheses .................................................................................................. 9 
3.3 
Feasibility assessment ................................................................................................................11 
4 
STUDY DESIGN ................................................................................................................................11 
4.1 
Type of Study .............................................................................................................................11 
4.2 
Study Setting ..............................................................................................................................12 
5 
PARTICIPANTS AND RECRUITMENT ................................................................................................12 
5.1 
Number of Participants ..............................................................................................................12 
5.2 
Eligibility Criteria ........................................................................................................................12 
5.2.1 
Inclusion criteria .....................................................................................................................12 
5.2.2 
Exclusion criteria ....................................................................................................................12 
5.3 
Recruitment and identification of potential participants ...........................................................13 
5.4 
Consent ......................................................................................................................................13 
5.4.1 
Consent to future use of data ................................................................................................13 
6 
RANDOMISATION AND BLINDING ..................................................................................................14 
7 
INTERVENTION ...............................................................................................................................14 
7.1 
Intervention arms.......................................................................................................................14 
7.2 
Intervention Period ....................................................................................................................14 
7.3 
Intervention Conditions .............................................................................................................14 
7.3.1 
Group 1: Alcohol Brief Intervention .......................................................................................14 
7.3.2 
Group 2: Control Group .........................................................................................................14 
8 
STUDY PROCEDURES ......................................................................................................................15 
8.1 
Study flow chart .........................................................................................................................15 
8.2 
Schedule of assessments............................................................................................................16 

 
 
 
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9 
ASSESSMENT ..................................................................................................................................16 
9.1 
SCREENING MEASURES ..............................................................................................................16 
9.2 
OUTCOME MEASURES ...............................................................................................................16 
9.2.1 
Primary outcome measure – Knowledge of alcohol as a breast cancer risk factor ................16 
9.2.2 
Alcohol Measures ...................................................................................................................17 
9.2.2.1 
14-day Timeline Followback ...................................................................................................17 
9.2.2.2 
AIHW alcohol frequency/quantity items ................................................................................17 
9.2.3 
Alcohol health literacy............................................................................................................17 
9.2.4 
Wellbeing and Health Measures ............................................................................................17 
9.2.4.1 
EUROHIS-QOL single item ......................................................................................................17 
9.2.4.2 
SF-12 ......................................................................................................................................17 
9.2.5 
Alcohol Brief Intervention Feasibility Questions ....................................................................17 
10 
PARTICIPANT WITHDRAWAL ......................................................................................................18 
10.1 
Withdrawing consent to participate and/or future use of data .................................................18 
10.2 
Discontinuation criteria and Investigator withdrawal ................................................................18 
10.3 
Losses to follow-up ....................................................................................................................18 
11 
ADVERSE EVENTS AND RISKS......................................................................................................19 
12 
DATA MANAGEMENT .................................................................................................................19 
12.1 
Data Collection ...........................................................................................................................19 
12.2 
Data Retention ...........................................................................................................................20 
13 
STUDY OVERSIGHT .....................................................................................................................20 
13.1 
Study Monitoring .......................................................................................................................20 
14 
STATISTICAL METHODS ..............................................................................................................21 
14.1 
Sample Size Estimation ..............................................................................................................21 
14.2 
Statistical Analysis Plan ..............................................................................................................21 
15 
ETHICS AND DISSEMINATION .....................................................................................................21 
15.1 
Research Ethics Approval ...........................................................................................................22 
15.2 
Modifications to the protocol ....................................................................................................22 
15.3 
Protocol Deviations ....................................................................................................................22 
15.4 
Confidentiality ............................................................................................................................22 
15.5 
Participant Reimbursement .......................................................................................................22 
15.6 
Financial Disclosure and Conflicts of Interest.............................................................................22 
15.7 
Dissemination and translation plan ............................................................................................22 

 
 
 
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REFERENCES ...........................................................................................................................................23 

 
 
 
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PROTOCOL SYNOPSIS 
TITLE 
Health4Her: Increasing knowledge of alcohol as a risk factor for breast cancer among 
women attending breast screening services 
OBJECTIVES 
Alcohol consumption is a major modifiable risk factor for breast cancer in women. 
Research demonstrates a strong link between alcohol and breast cancer risk, even at low 
drinking levels. This project aims to reduce alcohol consumption among women 
attending an Eastern Health BreastScreen service for routine mammography.  
DESIGN 
Pragmatic randomised controlled trial 
OUTCOMES 
Baseline, 4-week and 12-week measures will be administered.  
PRIMARY OUTCOME 
At 4-weeks post-randomisation, proportion of participants in the active condition 
(relative to control) accurately identifying alcohol as a clear risk factor for breast 
cancer. 
SECONDARY OUTCOMES 
At 4-weeks post-randomisation: 
- 
Change in participants' attitudes regarding alcohol and breast cancer risk 
(items adapted from previous literature, e.g. Fisher et al. 2017) 
- 
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 (items adapted 
from previous literature, e.g. Bowden et al. 2014) 
- 
Proportion of participants who have accessed health information on i) alcohol 
harms, ii) alcohol and breast cancer risk, and iii) alcohol harm-reduction 
At 4-weeks and 12-weeks post-randomisation: 
- 
Proportion of participants drinking less than or equal to 10 standard drinks per 
week (i.e. within current Australian Alcohol Guidelines) (14-day Timeline 
Followback; TLFB) 
- 
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) 
- 
Change in alcohol consumption (14-day TLFB; AIHW alcohol 
frequency/quantity items) 
- 
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) 
- 
Change in general health (SF-12) and quality of life (EUROHIS-QOL single item) 

 
 
 
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Feasibility of implementing alcohol brief intervention in a breast screening setting will 
be assessed through formative, process and impact evaluation,  examining factors such 
as: 
- 
The proportion of patients who agree to receive alcohol health promotion 
- 
Acceptability of the intervention prototype and research procedures 
- 
Women’s attitudes toward receiving alcohol health promotion intervention in 
the BreastScreen setting  
- 
Staff feedback on alcohol health promotion intervention implemented in the 
breast screen setting 
STUDY 
DURATION 
2.5 years 
INTERVENTIONS 
Active: 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. 
Control: 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. 
# PARTICIPANTS 
548 participants 
POPULATION 
Inclusion criteria:  
• 
Female, attending the BreastScreen setting for routine mammography 
• 
40+ years of age 
• 
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 

 
 
 
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1 
ADMINISTRATIVE INFORMATION  
1.1. 
Trial registration 
Trial to be registered with Clinicaltrials.gov, registration number: NCT04715516 
 
1.2. 
Expected duration of study 
This study is expected to take 24 months to complete. 
 
 
 
 
Jun 2019 – Feb 2021
Study set-up: (< Jun 2019: full protocol developed, ethics application submitted) 
finalise ethics approval, iOS software development, pamphlet development, full 
statistical analyses plan, randomisation schedule, REDCap database, RA 
recruitment and training, Maroondah BreastScreen site briefing 
(Sep 2019)  Set-up program evaluation, including formative evaluation with Lifepool
Feb 2021 – Nov 2021
Implement intervention: recruit 248 participants over 7 months, consent, baseline 
assessment, deliver alcohol brief intervention (or control), 4-week and 12-week 
follow-up telephone assessments, data entry.
(Aug 2021)  Last participant recruited 
(Nov 2021)  Last 12-week follow-up assessment completed
(Feb - Nov 2021)  Process and impact program evaluation
Sep 2021 - Feb 2022
Data cleaning, statistical and qualitative analyses, preparation of publications, 
finalise VicHealth reporting requirements (i.e. full research final report, research 
summary), acquittal report to EH Foundation, final report to HRECs, study archiving
(Aug – Dec 2021)  Implementation maintenance evaluation
Project Timeline – Health4Her
Dec 2019 - Sep 2020
Implement formative evaluation with Lifepool: online survey (N = 391) and focus
groups (N = 31) with women from the Lifepool community, to determine 
acceptability of alcohol and lifestyle health promotion offered within the breast 
screening setting, and to collaboratively design the health promotion content and 
research procedures planned for the Phase II trial. Adapt intervention accordingly.

 
 
 
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1.3. 
Contributorship  
 
Name 
Summary of contribution 
Professor Dan Lubman 
Turning Point, Eastern Health; Eastern Health 
Clinical School, Monash University 
Principal Investigator. Develop protocol. 
Oversee project management and the research 
team. 
Dr Jasmin Grigg 
Turning Point, Eastern Health; Eastern Health 
Clinical School, Monash University 
Co-Investigator. Develop protocol. Project 
management. 
Associate Professor Victoria Manning 
Turning Point, Eastern Health; Eastern Health 
Clinical School, Monash University 
Co-Investigator. Inform the development of 
protocol. Oversee project management. 
Professor Robin Bell 
Department of Epidemiology and Preventive 
Medicine, School of Public Health and 
Preventive Medicine, Monash University 
Co-Investigator (on the pilot component of this 
project only). Inform the development of 
protocol. Oversee project management. 
Dr Darren Lockie 
Maroondah BreastScreen, Eastern Health 
Co-Investigator. Inform the development of 
protocol. Oversee project implementation at 
Maroondah BreastScreen 
Associate Professor Liam Smith 
BehaviourWorks Australia, Monash Sustainable 
Development Institute, Monash University 
Co-Investigator. Inform the alcohol health 
promotion content. Inform the development of 
protocol. 
Associate Professor Peter Bragge 
BehaviourWorks Australia, Monash Sustainable 
Development Institute, Monash University 
Co-Investigator. Inform the alcohol health 
promotion content. Inform the development of 
protocol. 
Ms Michelle Clemson 
Maroondah BreastScreen, Eastern Health 
Co-Investigator. Oversee project 
implementation at Maroondah BreastScreen. 
 
 
2 
INTRODUCTION AND BACKGROUND 
Alcohol use is a major modifiable risk factor for breast cancer in women, even in low amounts, with 
evidence of a clear dose-response relationship. Indeed, meta-analyses reveal that the relative risk of 
breast cancer increases by 4%, 23% and 61% for light, moderate and heavy alcohol consumption, 
respectively (Bagnardi, 2015).  
Women who are eligible for mammography are typically aged 50-74 years and, due to their age, are 
at increased risk for breast cancer (McPherson, 2000; White, 2014). This is a population who are 
particularly vulnerable to the harmful effects of alcohol. While breast cancer mortality has reduced 
by 28-30% due to earlier detection (Roder, 2008) and improved treatment protocols (Burton, 2012), 
a key health promotion and disease prevention strategy is to reduce women’s drinking (WHO, 2017). 
In Australia, awareness of the link between alcohol and breast cancer is surprisingly low (Bowden, 
2014). While recommended upper limits of alcohol use are emerging as too generous, and 
associated with increased breast cancer risk, this is not widely understood even by health 
practitioners or policy makers, let alone the general population (Simapivapan, 2017). Low health 

 
 
 
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literacy regarding alcohol is a significant barrier to making informed decisions about reducing one’s 
alcohol use (Rundle-Thiele, 2013). 
Risky alcohol use – including daily drinking – is most common and stable among this cohort (AIHW, 
2016; Daly, 2009), yet remains largely under-detected (O’Connell 2003). As such, a large proportion 
of women do not receive information, advice or effective intervention. Delivering a targeted health 
promotion strategy aimed at reducing alcohol consumption, within the context of an already 
institutionalised breast screening program, represents a unique opportunity to prevent alcohol-
attributable harm in a large population for which there is great potential for health gain. 
Internationally, computerised alcohol brief interventions (i.e. feedback on personal drinking levels 
compared with age/gender norms, alongside information about alcohol risks/harms) have received 
strong empirical support as a simple, cost-effective method of reducing drinking and related harm 
(Donoghue, 2014), and one which overcomes the logistical issues of providing intervention within 
busy healthcare environments. 
No evidence currently exists regarding the utility of brief intervention delivered within breast 
screening services, a setting uniquely positioned to provide timely, strategic public health messages 
to prevent alcohol-attributable harm. With 240,970 Victorian women undergoing mammography in 
2015 (BreastScreen Victoria, 2016), this setting has the potential for extensive reach. The breast 
screening setting provides a significant opportunity to engage this population in alcohol health 
promotion, and complements and adds value to this established healthcare service. 
Therefore, we seek to conduct the first randomised controlled trial examining the efficacy of a 
computerised brief intervention in reducing risky drinking identified within a breast screening 
setting. 
 
 
3 
STUDY OBJECTIVES 
 
3.1 
Primary aim and hypothesis 
At 4-weeks post-randomisation, proportion of participants in the active condition (relative to 
control) accurately identifying alcohol as a clear risk factor for breast cancer.  
We hypothesise that at 4-weeks post-randomisation, compared to the control group, a greater 
proportion of participants receiving alcohol brief intervention will be able to accurately identify 
alcohol as a clear risk factor for breast cancer. 
3.2 
Secondary aims and hypotheses 
At 4-weeks post-randomisation: 
• 
Change in participants’ attitudes regarding alcohol and breast cancer risk (items adapted 
from previous literature, e.g. Fisher et al. 2017) 

 
 
 
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• 
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) 
Proportion of participants who have accessed health information on i) alcohol harms, ii) 
alcohol and breast cancer risk, and iii) alcohol harm-reduction 
We hypothesise that at 4 weeks post-randomisation, compared to the control group: 
(i) (Among women who drink >10 standard drinks per week at baseline) Participants 
receiving alcohol brief intervention will be significantly more likely to endorse an 
attitude of harm reduction toward alcohol and breast cancer risk 
(ii) A significantly greater proportion of participants receiving alcohol brief intervention will 
be able to accurately identify 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 
(iii) (Among women who drink >10 standard drinks per week at baseline) A significantly 
greater proportion of participants receiving alcohol brief intervention will have accessed 
health information on i) alcohol harms, ii) alcohol and breast cancer risk, and iii) alcohol 
harm-reduction 
At 4-weeks and 12-weeks post-randomisation: 
• 
Proportion of participants drinking less than or equal to 10 standard drinks per week (i.e. 
within current Australian Alcohol Guidelines) (14-day Timeline Followback; TLFB) 
• 
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) 
• 
Change in alcohol consumption (14-day TLFB; AIHW alcohol frequency/quantity items) 
• 
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) 
• 
Change in general health (SF-12) 
• 
Change in quality of life (EUROHIS-QOL single item) 
 
 
We hypothesise that compared to those in the control group, at 4-weeks and 12-weeks post-
randomisation: 
(iv) A significantly greater proportion of participants receiving alcohol brief intervention will 
be drinking less than or equal to 10 standard drinks per week (i.e. within current 
Australian Alcohol Guidelines) 

 
 
 
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(v) Of participants who drink more than 10 standard drinks per week, a significantly greater 
proportion of those receiving alcohol brief intervention will be drinking less than 10 
standard drinks per week 
(vi) Participants receiving alcohol brief intervention will report significantly greater 
reductions in alcohol consumption 
(vii) Of participants who drink more than 10 standard drinks per week, those receiving the 
alcohol brief intervention will report significantly greater reductions in alcohol 
consumption 
(viii) 
Participants receiving alcohol brief intervention will report significantly greater 
improvements in general health and quality of life 
 
3.3 
Feasibility assessment 
Feasibility of implementing the alcohol brief intervention in a breast screening setting will be 
assessed through formative, process and impact evaluation, by examining factors such as: 
(i) The proportion of patients who agree to receive alcohol health promotion 
(ii) Acceptability of the intervention prototype and research procedures 
(iii) Women’s attitudes toward receiving alcohol health promotion intervention 
(iv) Staff feedback on alcohol health promotion intervention implemented in the breast screen 
setting 
 
 
4 
STUDY DESIGN 
 
4.1 
Type of Study 
This study is a single site, parallel group, two arm, pragmatic randomised controlled trial (RCT), with 
participants randomly allocated to receive either:  
 
Active: Alcohol brief intervention + lifestyle health promotion  
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. 
 
Control: lifestyle health promotion, not inclusive of alcohol information 
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 

 
 
 
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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. 
 
4.2 
Study Setting  
The proposed pilot study will be conducted at Eastern Health’s Maroondah BreastScreen. This 
service has an annual throughput of 29,824 women (~570 per week), making it an ideal setting to 
test the alcohol brief intervention.  
The study will be conducted in line with Eastern Health’s COVIDSafe Plan to ensure the safety of 
Maroondah BreastScreen’s clients and staff as well as Researcher 1, who will be recruiting 
participants and conducting the baseline assessment. COVID-19 safety procedures will include, for 
example, wearing of masks by the Researcher and participants, using alcohol wipes to clean iPad 
devices prior to and after each use, the provision of single-use earphones to watch the health 
promotion video (which women can take home with them), the maintenance of physical distancing 
and limiting researcher-participant interactions to a maximum of 15 minutes.  
 
5 
PARTICIPANTS AND RECRUITMENT   
 
5.1 
Number of Participants 
The study aims to recruit 548 participants (274 participants per trial arm). 
 
5.2 
Eligibility Criteria 
Individuals will be randomly assigned to one of the study treatments only if they meet eligibility 
criteria.  
 
5.2.1 
Inclusion criteria 
Individuals must meet all of the following criteria to be enrolled in this study:  
• 
Female, attending the BreastScreen setting for routine mammography  
• 
Aged 40+ years 
• 
English as a first language or fluent 
• 
Regular access to a telephone  
• 
Able to provide informed consent to participate 
Women at any level of alcohol risk, including non-drinkers, will be eligible to participate to determine 
any change in non-drinking status and other outcomes over time. This approach also serves to negate 
the stigma that may occur if only women drinking at risky levels are included in the study. 
 
5.2.2 
Exclusion criteria 
Individuals meeting any of the following criteria will be excluded from the study:  
• 
Hearing impairment sufficient to prohibit a telephone interview 
• 
Pregnancy 

 
 
 
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• 
Not able to read or comprehend English to provide informed consent or receive the brief 
intervention 
 
 
5.3 
Recruitment and identification of potential participants 
Recruitment will occur at the Maroondah BreastScreen site 2-days per week over 7 months from Feb 
2021. Women will be sent a study flyer with their breast screening appointment reminder email 3 
days prior to their appointment. Maroondah BreastScreen reception staff will provide a reminder 
text message or phone call one day prior to recruitment days to flag the study occurring onsite (as 
well as confirming women’s attendance). Upon arrival at Maroondah BreastScreen, the receptionist 
will query whether women are aware of the study and provide them with a study flyer to read while 
waiting for their appointment. Study posters will also be visible on the waiting room notice board 
and in the screening rooms. At the end of the screening appointment, the radiographer will ask 
whether the client would like to hear more about the study from the onsite researcher / be involved, 
and if the client agrees or has further questions, the radiographer will introduce the client to 
Researcher 1. Participation in the study will occur only after the screening appointment is complete. 
A script has been developed to assist Researcher 1 with discussing the project with potential 
participants.  
5.4 
Consent 
Researcher 1 will either i) provide a verbal explanation of the trial (aims, procedures, risks and 
benefits), in lay terms, to women who are interested in participating, guided by the participant 
information sheet; or ii) (if the Researcher is finishing up with another participant) provide a written 
summary of the trial (aims, procedures, risks and benefits), guided by the participant information 
sheet. Potential participants will have the opportunity to discuss the trial and ask questions. 
Participants will be advised that they can withdraw from the study at any time without prejudice and 
that their decision whether to take part or not to take part, or to take part and then withdraw, will 
not affect their routine care or their relationship with Maroondah BreastScreen or Eastern Health. 
Women who are willing to take part will be asked to provide either i) verbal informed consent to 
participate in the study, recorded by Researcher 1 in the trial’s REDCap electronic data form; or ii) 
written consent to participate in the study, recorded in paper form. Participants will be asked to 
provide consent to the following items: 1. I consent to participate in the computer survey and health 
promotion. 2. I consent to receive two follow-up calls from a study researcher, in 4 and 12 weeks’ 
time. 3. I consent to the information I provide for this project to be used in possible future related 
projects, as described in the Participant Information Sheet. I understand that future, related projects 
will only ever use my information in such a way that I cannot be identified. 
A copy of the participant information sheet will be provided to the participant. The consent process 
and participation in study procedures will occur after the participant’s breast screen appointment, 
so as to not interfere with routine service delivery. 
5.4.1 
Consent to future use of data 
As part of informed consent, and outlined in the participant information sheet, participants will be 
asked to provide their consent for their re-identifiable data (i.e. their name will not be attached to 
the data, but only by the unique participant code assigned to both personal information and data, 
making the data technically re-identifiable), to be used in any future, related research projects 
conducted by the research team or for student projects. Separate ethics approval will be sought for 
any subsequent, related project requesting to use these data. Security of participant data will be 

 
 
 
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upheld at all times, and persons working with the research team on subsequent, related studies will 
not ever have access to participants’ personal information/identifiable data, nor the spreadsheet 
containing re-identifiable information. 
 
6 
RANDOMISATION AND BLINDING 
Women who consent to participate will complete a quick demographic questionnaire and a series of 
brief measures (evaluating alcohol use, alcohol literacy, quality of life and general health) 
administered by Researcher 1 or partially self-completed if the Researcher is helping another 
participant, before being provided with an iPad and randomised at a 1:1 ratio (using computer 
sequenced block randomisation) to receive the computerised active or control condition.  
Randomisation will use a standard computer generated “permuted blocks of variable size” scheme 
for each stratum. Randomisation lists for each stratum will be generated at the start of the study by 
the data scientist assisting with the development of the iPad intervention and linked to a unique 
identification code. The data scientist will play no other role in the randomisation. Randomisation 
will be linked to a unique identification code, which will be in a re-identifiable format.  
Participants will be informed that the study is concerned with promoting health across a range of 
lifestyle factors (e.g. alcohol use, diet/exercise), which accurately corresponds to the planned 
outcome measures and intervention conditions and therefore will blind participants to group 
allocation. Intervention and control computer tasks will be visually identical and will be self-paced. 
The study researcher performing outcome assessments (Researcher 2) is expected to remain blind to 
trial allocation.   
7 
INTERVENTION 
7.1 
Intervention arms  
There will be two trial arms (alcohol brief intervention, control group). 
7.2 
Intervention Period 
The intervention period runs for 4-7 minutes.  
7.3 
Intervention Conditions 
7.3.1 
Group 1: Alcohol Brief Intervention 
Nested within the lifestyle health promotion provided in both conditions, participants randomised to 
the experimental condition will receive an alcohol brief intervention (7 minutes total). 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). 
7.3.2 
Group 2: Control Group 
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 to Group 2 (4 minutes 

 
 
 
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total). Data from several studies suggest that mere exposure to baseline questions about alcohol use 
can impact positively on alcohol consumption levels (McQueen, 2011). Baseline questioning effects 
may operate through similar mechanisms, prompting reflection and the self-regulation of behaviour 
(McCambridge, 2011). Still, pooling effect sizes over large numbers of alcohol BI studies has been able 
to provide a powerful estimate of how this form of health promotion performs (Kaner, 2007; 
McQueen, 2011; O'Donnell, 2013). Therefore, while participants in the control condition may 
experience some benefit from participation, we expect this will be less than that obtained for the 
active condition. 
 
8 
STUDY PROCEDURES  
 
8.1 
Study flow chart  
 
  
RECRUITMENT
Maroondah BreastScreen onsite recruitment 
Onsite Researcher: 2 days per week over 6 months from Feb 2021
ELIGIBILITY, INFORMED CONSENT, BASELINE
Performed by Researcher 1: (i) PIS provided and trial explained, (ii) 
Eligibility assessed, (iii) informed consent sought, (v) brief baseline 
assessment administered by Researcher 1
PARTICIPANT RANDOMISATION
1:1 ratio using computer sequenced block randomisation embedded 
in the iPad software
Group 2: 
Lifestyle health promotion, 
not inclusive of alcohol 
information
Group 1: 
Alcohol Brief Intervention + 
lifestyle health promotion
FOLLOW UP ASSESSMENTS
Performed by Researcher 2 via telephone at 4-weeks and 12-weeks 
post-intervention (primary and secondary outcome measures; 
feasibility questions)
Researcher 1 collect 
staff feedback on alcohol 
brief intervention 
implemented in the 
breast screen setting

 
 
 
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8.2 
Schedule of assessments 
 
  
Pre-trial 
BreastScreen 
setting 
Telephone 
Telephone 
Week:  
  
0 
4 
12 
Trial explanation 
  
x 
 
 
Eligibility 
  
x 
 
 
PIS provided 
  
x 
 
 
Informed consent 
  
x 
 
 
RANDOMISATION 
  
x 
 
 
INTERVENTION 
  
x 
 
 
MEASURES 
  
 
 
 
Alcohol Use (14-day Timeline Followback; AIHW 
alcohol frequency/quantity items)) 
  
x 
x 
x 
Alcohol literacy (attitudes, knowledge - primary 
outcome, access to further information) 
  
x 
x 
 
Quality of life (EUROHIS-QOL single item) 
  
x 
x 
x 
General health (SF-12) 
  
x 
x 
x 
Feasibility questions (trial participants) 
  
 
 
x 
Feasibility questions (focus groups and survey 
with Lifepool women) 
x 
  
  
  
 
 
9 
ASSESSMENT 
Researcher 1 will perform the eligibility assessment. Follow-up assessments (4-week, 12-week) will 
be conducted over the telephone by Researcher 2. Baseline and follow-up assessments will take 5-10 
minutes to complete. 
9.1 
SCREENING MEASURES 
Standard demographic characteristics (e.g., age, gender, education level) will be recorded during the 
initial eligibility assessment, as well as information pertaining to the study’s inclusion/exclusion 
criteria.  
9.2 
OUTCOME MEASURES 
9.2.1 
Primary outcome measure – Knowledge of alcohol as a breast cancer risk 
factor 
An item adapted from previous research in this area (e.g. Fisher, Wilkinson et al. (2017)) will be used 
to measure participants’ knowledge of alcohol as a breast cancer risk factor. Participants will be 
asked to rate 6 factors (family history of breast cancer, physical inactivity, antiperspirant deodorant 
use, alcohol, processed meats and being overweight) as either a clear risk factor for breast cancer 
(“there is strong, consistent evidence that this factor increases the risk of breast cancer”), possible 
risk factor (“there is some evidence that this factor increases the risk of breast cancer, but not 
enough to be certain”), not a proven risk factor (“the evidence is too limited to determine whether 
this factor increases the risk of breast cancer”), or unsure.  The correct responses were taken from 
Cancer Australia’s 2018 review of the evidence on breast cancer risk factors (Cancer Australia 2018).  
The primary outcome will be the proportion of participants in the active condition (relative to 

 
 
 
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control) who accurately identify alcohol as a clear risk factor for breast cancer at 4-weeks post-
intervention.  
9.2.2 
Alcohol Measures 
9.2.2.1 14-day Timeline Followback  
The 14-day Timeline Followback (TLFB) (Sobell and Sobell 1992) is a calendar-based assessment tool 
created to assist participant recall of drug and alcohol consumption over the previous month, with 
well-established psychometric properties (Agrawal, Sobell et al. 2008, Robinson, Sobell et al. 2014). 
The TLFB will be used to measure amount of alcohol consumed over the past 14 days and to inform 
normative feedback provided in the brief intervention.  
9.2.2.2 AIHW alcohol frequency/quantity items  
The Australian Institute of Health and Welfare (AIHW) alcohol frequency/quantity items will be used 
to measure frequency / volume of alcohol consumption, and to inform normative feedback provided 
in the brief intervention. It consists of two items which ask about past-month frequency alcohol 
consumption, and the number of drinks consumed on a typical drinking day.  
9.2.3 
Alcohol health literacy 
Alcohol health literacy will be measured using a brief questionnaire to ascertain the following: i) 
attitudes regarding alcohol and breast cancer risk using a series of 5-point Likert scales from strongly 
agree to strongly disagree (adapted from previous literature, e.g. Fisher, Wilkinson et al. (2017)); ii) 
alcohol knowledge (additional to the primary outcome) using a series of multiple choice and open-
ended questions (i.e. amount of alcohol in an Australian standard drink, standard drinks in an 
average restaurant serve of wine, knowledge of Australian Alcohol Guidelines) adapted from 
previous literature (e.g. Bowden, Delfabbro et al. (2014)); and iii) access to health information on 
alcohol harms, alcohol-breast cancer risk, and alcohol harm reduction. Alcohol items will be nested 
among general health questions to conceal the focus on alcohol. 
9.2.4 
Wellbeing and Health Measures 
9.2.4.1 EUROHIS-QOL single item 
The EUROHIS-QOL 8-item index (Nosikov and Gudex 2003) is a reliable and valid instrument for 
assessing quality of life (QOL). It demonstrates cross-cultural performance and is recommended for 
use in public health research (Schmidt, Mühlan et al. 2006). We will be using the global question 
(“On a scale of 1 to 5, with 1 being “very poor” and 5 being “very good”, how would you rate your 
quality of life?”) from the EUROHIS-QOL 8-item index, which has been validated for use as a single-
item approach to assessing QOL (Nosikov and Gudex 2003). 
9.2.4.2 SF-12 
The widely used 12-Item Short-Form Health Survey (SF-12) (Ware, 1998) will be used in this study as 
a brief measure of general health. 
9.2.5 
Alcohol Brief Intervention Feasibility Questions  
Feasibility of the alcohol brief intervention in a breast screening setting will be assessed by 
examining women’s attitudes toward receiving alcohol health promotion intervention in the context 
of the breast screening setting.  

 
 
 
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Before the trial commences, focus groups (V1 27 08 19) recruited from Lifepool (a participant 
resource of Victorian women who are eligible for/have had a screening mammogram) will be used to 
test the acceptability of the intervention prototype and research procedures. A survey (V1 27 08 19) 
will also be sent to Lifepool participants to determine women’s views on receiving alcohol advice in 
the context of the BreastScreen setting. We will also access existing Lifepool data to examine alcohol 
consumption levels (i.e. need for alcohol brief intervention) in this cohort of women who are 
eligible/have had a screening mammogram. Relevant approvals will be sought from Lifepool. 
Brief telephone semi-structured interviews with trial participants at follow-up will elicit feedback on 
the intervention (e.g. “which parts, if any, of the computerised health promotion were most helpful 
to you? How were these most helpful?”; “What did you think about the delivery, format and duration 
of the computerised health promotion?”). A subsample of the active arm (~30 participants who are 
not abstainers) will be selected, using random start systematic sampling, to provide this feedback. 
Verbal consent will be sought to voice record feedback sessions. Confidentiality and privacy of 
recordings will be upheld at all times, and will be stored securely, in line with ethical and regulatory 
requirements.     
Staff feedback on alcohol health promotion intervention implemented in the breast screen setting 
will also be sought by way of a brief survey.  
10 PARTICIPANT WITHDRAWAL 
10.1 
Withdrawing consent to participate and/or future use of data 
All participants have the right to withdraw their consent to take part in the trial. The right to 
withdraw without consequence (i.e. without affecting their care received by Maroondah 
BreastScreen or Eastern Health) will be outlined during the consenting process and in the participant 
information sheet. If a participant wishes to withdraw consent, verbal revocation of consent can be 
provided by the participant. No further contact with the participant will be initiated by the research 
team upon verbal revocation of informed consent. Participants will have the option to remove all of 
their previously collected data or just remove consent for further data collection. 
10.2 
Discontinuation criteria and Investigator withdrawal 
In instances where it has been identified that a participant meets exclusion criteria during the study, 
this will be explained sensitively to the individual, with referral to appropriate support as required.  
Where it has been identified that it is not in the best interests of the participant to remain in the 
study (i.e. during follow-up), Researcher 2 will alert the Principal Investigator who, in deliberation 
with Co-Chief Investigators when necessary, will make the decision whether to withdraw the 
participant from the trial. In the event that it is determined appropriate to withdraw a participant 
from the trial, the reasoning for this will be explained sensitively to the participant. The participant 
will be withdrawn and offered information on how to access other support.  
Following withdrawal from the trial no further data collection will occur, with the exception of the 
details regarding adverse events, as described in section 11 of this protocol.  
 
10.3 
Losses to follow-up 
Participants who cannot be contacted after 5 phone calls will be deemed to be missing at that data 
collection time point. The research team will attempt to contact them again at the next data 
collection time point, following the same procedure. 

 
 
 
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11 ADVERSE EVENTS AND RISKS  
11.1  
Risks 
The risks of harm and discomfort to participants are anticipated to be relatively minor. Some 
participants who do experience alcohol problems may find that discussing their alcohol use 
(including at follow-up assessments) triggers cravings for alcohol or psychological distress. However, 
our experience from previous studies suggests that this is uncommon and any distress is usually 
minor and transient. 
11.2  
Adverse Events 
The research team will look out for possible adverse effects throughout the conduct of this trial. Any 
adverse events (AEs) or serious adverse events (SAEs) occurring during the course of this study, 
whether or not they are deemed to be related to participation in this study, will be followed 
rigorously, and in conjunction with the participant’s treating primary care practitioner (PCP) when 
required (PCP details will be requested from the participant when this is deemed appropriate). 
Participants will be withdrawn from the study if any events compromise their treatment or well-
being.  
11.3  
Additional support and resources 
During baseline and telephone follow-up assessments, all participants will be advised to contact 
their primary care provider if they are concerned about any aspect of their health raised during the 
course of this research (i.e. alcohol use, general health and lifestyle factors). Take home pamphlets 
for women receiving the alcohol information (active arm) will contain the contact details for 
additional sources of support (e.g. DirectLine, CounsellingOnline). The researcher performing follow-
up assessments will also provide participants with specific contact details for additional support 
whenever a need for this is identified.  
 
12 DATA MANAGEMENT 
12.1 
Data Collection 
There are several components of data collection and storage for this trial. 
An electronic Case Report Form (eCRF) will be completed for each participant using REDCap 
(Research Electronic Data Capture), which contains all demographic, screening and study data. 
REDCap is a secure, web-based application designed to support data capture and storage for 
research studies collecting highly sensitive information (including case report forms, real time data 
entry validation and audit trails). REDCap is hosted on a secure server and managed by Eastern 
Health IT Services, and researchers access it via a secure login. Only approved members of the 
research team will have access to the eCRF. While a unique identifying code is generated by REDCap 
in order to retain data integrity, REDCap is used to collect all data for participants, which means that 
it stores identifiable data (i.e. name, contact information) as well as study data (i.e. participant 
responses to trial measures). However, identifiers will be flagged in REDCap, which then provides 
additional protection for these data elements (e.g. identifiers can then be automatically removed 
from all data exports where the user does not have permission to export identifiers). Data access 
and identifiers will be accessible only to the Co-Primary investigator (Jasmin Grigg) and the research 
assistants conducting baseline and follow-up assessments. On completion of the data collection, 

 
 
 
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non-identifiable trial data will be transferred from the eCRF to a statistical software package for 
analysis. 
The Qualtrics Insight Platform, a secure platform and Monash University’s preferred online survey 
tool which uses Transport Layer Security (TLS) encryption (also known as HTTPS) for all transmitted 
data, will be used for some data collection in this study – i.e. the baseline data on alcohol 
consumption that precedes the alcohol/control brief intervention provided to participants on the 
iPad. Data includes identifiable (i.e. first name only) and re-identifiable information (i.e. screening 
number, randomisation number). Participants’ first name (i.e. identifiable information) is required in 
order to generate the personalised alcohol/control brief intervention. Identifiers will be removed 
from all exported data generated by Qualtrics before being transferred to a statistical software 
packaging for analysis. Access to Qualtrics data is via a secure login and will be limited to the 
research assistant directly involved in baseline data collection and Dr Jasmin Grigg. 
Spread sheets containing identifiable information (i.e. name, contact number) and re-identifiable 
information (i.e. screening number, randomisation number) as well as administrative information 
will be used for the purpose of a) recruitment, and b) conducting follow-ups. These spreadsheets will 
only be accessed by the research assistants performing these roles, and will be password-protected 
and held on secure drives.  
Electronic calendar-calculator spreadsheets containing TLFB substance use data contain only re-
identifiable information (i.e. screening number, randomisation number) will only be accessed by the 
research assistants performing these roles, and will be password-protected and held on secure 
drives.  
As paper records need to be used because of the fast pace of this trial (i.e. baseline assessments are 
partially completed by the participant in paper form) and will be PDF replicas of the trial’s REDCap 
forms, it is not always feasible to remove identifiable information from the study data recorded on 
these paper records. All information in paper form will be stored securely in a locked filing cabinet 
on a secure level at Turning Point, and will be accessible only to the researchers conducting data 
collection and the trial manager, Dr Jasmin Grigg.  
 
12.2 
Data Retention 
All data collected during this study will be retained by the Investigator for a period of 5 years as 
outlined in the Australian Code for the Responsible Conduct of Research. 
 
13 STUDY OVERSIGHT  
13.1 
Study Monitoring  
The Chief Investigators of this study have expertise relevant to the trial and capacity to monitor the 
research team, monitor compliance with the protocol, monitor compliance with ethical and clinical 
governance, provide standardised training and other means of quality control and assurance as 
appropriate, oversee trial arm fidelity, monitor adverse events reported, and provide necessary 
support to the research team (e.g. debriefing). Regular liaison between the research staff and 
Principal Investigator will occur to permit discussion of day-to-day trial progress and any potential 

 
 
 
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concerns. The broader research team will meet intermittently to review overall progress of the 
project. 
 
 
14 STATISTICAL METHODS 
14.1 
Sample Size Estimation 
Since the aims of this pilot RCT include preliminary hypothesis testing for effectiveness, a power and 
sample size calculation has been performed (Moore, Carter et al. 2011). Power and sample size 
estimates were carried out using PS: Power and Sample Size Calculation V3.1.2 (Dupont and 
Plummer 1990), assuming a type 1 error probability of α <0.05, 2-tailed, and equal-sized groups. 
Power calculations are based on the primary endpoint, proportion of participants who accurately 
identify alcohol as a clear risk factor for breast cancer.  
Our sample size estimation is based on our previousonline survey study with 391 women who have 
attended/are eligible to attend breast screening services (Health4Her Phase I). If the proportion of 
control participants who accurately identify alcohol as a clear risk factor for breast cancer is 0.22 and 
the true response rate for participants receiving the alcohol brief intervention is 12% greater at 0.34, 
and compensating for 20% attrition at follow-up, then 548 participants (274 per arm) will provide 
power of 80% to be able to reject the null hypothesis. 
Given the lack of definitive evidence regarding alcohol BI effects in women, and particularly women 
of middle- and older-age in a breast screening setting, this powered pilot RCT will inform the 
development of a subsequent, comprehensive multicentre trial. This pilot RCT will generate 
preliminary data on intervention response using exploratory surrogate/proximal markers of 
effectiveness (e.g. proportion of participants accurately identifying alcohol as a breast cancer risk 
factor, proportion of participants drinking within guidelines, alcohol consumption and well-being), 
and will provide concrete estimates of risky alcohol consumption prevalence, and expected rates of 
missing data and participant attrition specific to the population under study (Moore, Carter et al. 
2011).  
14.2 
Statistical Analysis Plan  
 
A detailed statistical analysis plan will describe the statistical methods for each outcome as well as 
how missing data will be dealt with. Data will be collated, cleaned and validated, using programmed 
edit checks, in a database that will be locked prior to analyses. All statistical tests will be two-tailed, 
with alpha level set to 0.05. Statistical analyses will be adjusted for multiple comparisons when 
indicated. 95% confidence intervals will be reported throughout. All randomised participants will be 
included in the analysis (i.e. intention-to-treat) for primary and secondary outcomes. Demographic 
characteristics (e.g. age) and baseline measurements (e.g. knowledge of alcohol as a clear risk factor 
for breast cancer, alcohol consumption) will be summarised and reported by intervention arm. The 
analyses will examine change in outcomes over time (4-weeks and/or 12-weeks) relative to baseline. 
The complete details of the analyses will be specified in a Statistical Analysis Plan that will be 
reviewed and approved by a study team prior to database lock. Analyses will be conducted using the 
most appropriate procedures in R and STATA. 
 
15 ETHICS AND DISSEMINATION   
This study will be carried out according to the Declaration of Helsinki, the NHMRC National 
Statement on Ethical Conduct in Research Involving Humans (1999) and the Notes for Guidance on 

 
 
 
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Good Clinical Practice as adopted by the Australian Therapeutic Goods Administration (2000) 
(CPMP/ICH/135/95) and the ICH GCP Guidelines. 
15.1 
Research Ethics Approval 
This protocol and the informed consent document and any subsequent modifications will be 
reviewed and approved by the Eastern Health Human Research Ethics Committee (HREC). A letter of 
protocol approval by the HREC will be obtained prior to the commencement of the study, as well as 
approval for other study documents subject to HREC review. It is the responsibility of the Principal 
Investigator to report annual study progress to the Eastern Health HREC. 
15.2 
Modifications to the protocol  
Protocol amendments will be submitted to the Eastern Health HREC. No changes to the protocol will 
be implemented without prior approval. 
15.3 
Protocol Deviations  
All protocol deviations must be recorded on the CRF and must be reported to the Principal 
Investigator. Protocol deviations will be assessed for significance by the Principal Investigator, and 
reported to the Eastern Health HREC if deemed to have a potential impact on the integrity of the 
study results, patient safety or ethical acceptability of the trial. 
15.4 
Confidentiality 
The trial will be conducted in accordance with applicable Privacy Acts and Regulations. All 
information regarding trial participants must be treated in strict confidence. Data, which identify any 
trial participant, must not be revealed to anyone not directly involved in the trial or the clinical care 
of that participant. 
15.5 
Participant Reimbursement 
Trial participants will go into a draw to win one of ten $100 supermarket vouchers. For the pre-trial 
component of this project being undertaken with the Lifepool cohort, an incentive of a pledge of $1 
to breast cancer research for every survey completed will be used to optimise survey participation. 
Additionally, an incentive of a pledge of $10 to breast cancer research for focus group participation 
will be used to optimise participation. 
15.6 
Financial Disclosure and Conflicts of Interest 
The trial is funded via a 2019 Eastern Health Foundation Research and Innovation Grant and a 
VicHealth Impact Research Grant.  
15.7 
Dissemination and translation plan 
Dissemination of findings to the research community will be via peer-reviewed publications and 
conference presentations. Participants will be informed they can access the Eastern Health website 
for a summary report of trial findings in 2022. The summary report will also be made available at 
Maroondah BreastScreen.  
 
 
 

 
 
 
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