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

 
 
 
Study Name: Health4Her-Automated 
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PROTOCOL 
 
Health4Her-Automated: A novel scalable brief intervention to 
address alcohol intentions and consumption among women 
attending breast screening services 
 
ClinicalTrials.gov Registration Number: NCT06019442 
Protocol Version # and date: Version 4, 11th August 2023 
 
Revision Chronology: 
Date of change 
Summary of changes 
8th November 2022 
Version 1: original document 
1st February 2023 
Version 2: further elaboration in line with HREC pre-review regarding limited disclosure and how 
this will be addressed in the summary report available to trial participants at study end. 
16th March 2023 
Version 3: Addition of a small pilot group (n~20) unable to participate on the day of screening, 
who are willing to complete a modified version of the active intervention offsite, thereby 
addressing potential issues with implementation identified in the previous phase of this 
research. New exclusion criterion: women who participated in the previous Health4Her study 
will be excluded from participating in H4H-A. 
11th August 2023 
Version 4: Update intervention description based on breast screening service consumer 
feedback. Addition of electronic summary information sent after intervention delivery. Update 
data security information. Addition of two secondary outcomes to assess change in the 
proportion of participants intending to reduce their alcohol consumption, and amendment to 
one literacy outcome in line with new intervention content. 
Investigators 
Dr Jasmin Grigg 
Ms Peta Stragalinos 
Dr Darren Lockie 
Ms Michelle Giles 
Prof Robin Bell 
Dr Alex Waddell 
Mr Joshua Seguin 
Dr Ling Wu 
Dr Jue Xie 
Mr Chris Prawira 
Dr Bosco Rowland 
Dr Chris Greenwood 
A/Prof Victoria Manning 
Prof Dan Lubman 
Sponsor 
Eastern Health 
Funded By 
Shades of Pink 
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 
1 
ADMINISTRATIVE INFORMATION ................................................................................................. 4 
1.1. 
Trial registration ........................................................................................................................... 4 
1.2. 
Expected duration of study .......................................................................................................... 4 
2 
INTRODUCTION AND BACKGROUND............................................................................................ 4 
3 
STUDY OBJECTIVES ....................................................................................................................... 5 
3.1 
Randomised controlled trial outcomes/hypotheses .................................................................... 5 
4 
STUDY DESIGN .............................................................................................................................. 6 
4.1 
Collaborative design of H4H-A ..................................................................................................... 7 
4.2 
Randomised controlled trial of H4H-A ......................................................................................... 7 
4.3 
Program evaluation ....................................................................................................................10 
5 
CONSENT ....................................................................................................................................10 
5.1 
Participation in the collaborative design of H4H-A ....................................................................10 
5.2 
Participation in the randomised controlled trial of H4H-A .........................................................11 
5.3 
Participation in qualitative program evaluation .........................................................................12 
6 
STUDY PROCEDURES ..................................................................................................................12 
6.1 
Study flow chart .........................................................................................................................12 
6.2 
Schedule of assessments............................................................................................................12 
7 
ASSESSMENTS ............................................................................................................................13 
7.1 
SCREENING MEASURES ..............................................................................................................13 
7.2 
OUTCOME MEASURES ...............................................................................................................13 
7.2.1 Primary outcome measure – drinking intentions .......................................................................13 
7.2.2 Drinking intentions .....................................................................................................................13 
7.2.3 Knowledge of alcohol as a breast cancer risk factor ..................................................................14 
7.2.4 Alcohol literacy ...........................................................................................................................14 
7.2.5 Alcohol consumption .................................................................................................................14 
7.2.6 Knowledge of other breast cancer risk factors ..........................................................................14 
8 
PARTICIPANT WITHDRAWAL ......................................................................................................15 
8.1 
Withdrawing consent to participate and/or future use of data .................................................15 
8.2 
Losses to follow-up ....................................................................................................................15 
9 
ADVERSE EVENTS AND RISKS......................................................................................................15 
9.1 
Risks ...........................................................................................................................................15 
9.2 
Adverse Events ...........................................................................................................................15 

 
 
 
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10 
DATA MANAGEMENT .................................................................................................................16 
10.1 
Data Collection ...........................................................................................................................16 
10.2 
Data Retention ...........................................................................................................................18 
11 
STUDY OVERSIGHT .....................................................................................................................18 
11.1 
Study Monitoring .......................................................................................................................18 
12 
ETHICS AND DISSEMINATION .....................................................................................................18 
12.1 
Research Ethics Approval ...........................................................................................................18 
12.2 
Modifications to the protocol ....................................................................................................18 
12.3 
Protocol Deviations ....................................................................................................................18 
12.4 
Confidentiality ............................................................................................................................18 
12.5 
Participant Reimbursement .......................................................................................................19 
12.6 
Financial Disclosure and Conflicts of Interest.............................................................................19 
12.7 
Dissemination and translation plan ............................................................................................19 
REFERENCES ...........................................................................................................................................20 
 

 
 
 
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1 
ADMINISTRATIVE INFORMATION  
1.1. 
TRIAL REGISTRATION 
Trial to be registered with ClinicalTrials.gov, registration number: NCT06019442 
 
1.2. 
EXPECTED DURATION OF STUDY 
This study is expected to take 12-months to complete (6-months to complete collaborative design and 
automation of the Health4Her platform; 6-months to conduct the effectiveness-implementation trial, 
and analyse the results)  
 
2 
INTRODUCTION AND BACKGROUND 
Alcohol is a major modifiable risk factor for breast cancer in women (4.4% breast cancer cases globally 
and 5.8% breast cancer cases in Australia are attributable to alcohol consumption) (1, 2), even in low 
amounts (3). Yet, population awareness of this risk remains low (<20%) (4, 5). 
In Australia, per capita alcohol consumption is declining, yet risky drinking including daily drinking has 
remained stable among women aged 40+ years, and has even increased among those aged 50-69 
years (6). While consumption earlier in life is also relevant to breast cancer development, recent intake 
is a determinant of breast cancer risk (7, 8), particularly after age 40 where consumption is strongly 
associated with breast cancer risk (7). Further, among women with a breast cancer history, alcohol 
intake of <1 standard drink per day is associated with an increased risk of breast cancer recurrence 
(9). Despite this, mid-older age women’s drinking remains largely under-recognised (10) and has not 
been a target of breast cancer prevention efforts. 
Alcohol brief interventions are recommended in the recently updated Australian guidelines for the 
treatment of alcohol use problems (11), and there is an expansive literature demonstrating their 
effectiveness in improving alcohol literacy and reducing consumption when delivered in general 
practice settings (12, 13). However, multiple barriers to their implementation remain (e.g. longer 
consultations are not adequately remunerated, training is suboptimal, and treatment services are not 
readily available when advice or referral is required), and there has been a call for other health 
profession involvement in responding to harmful alcohol consumption and leading clinical practice 
change to reduce alcohol-related harms (14). Population-based breast screening programs are 
uniquely positioned to provide timely and targeted health information and behaviour change 
strategies to improve women’s alcohol literacy and reduce consumption; the screening appointment 
can act as a window of opportunity to increase engagement with breast cancer risk reduction 
information. With approximately 43 million women participating in breast screening each year in 
Australia, the US and UK alone, this setting has potential for extensive reach.  
We recently completed a world-first trial (N=558), funded by VicHealth and the Eastern Health 
Foundation, supported by Maroondah BreastScreen (trial site) and BreastScreen Victoria, and 
approved by the Eastern Health Human Research Ethics Committee (LR19/011/50551), to test the 
effectiveness of a prototype of an electronic alcohol brief intervention (Health4Her; researcher-

 
 
 
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administered screening alcohol questions, intervention activated by the researcher for the participant 
to view on an iPad alone). The electronic alcohol brief intervention model was chosen to minimise 
disruption to service workflow and need for human resource to implement within the busy breast 
screening environment. In this trial, participants reported poor alcohol literacy (4 in 5 did not have 
knowledge of the alcohol-breast cancer link) and a desire for more information. The Health4Her 
intervention was found to be highly acceptable to breast screening service consumers. For the primary 
outcome, there were significant increases in the proportion of participants accurately identifying 
alcohol as a clear breast cancer risk factor from baseline to 4-weeks in intervention (OR=41.82, 95% 
CI=17.76, 98.49, p<0.001) and control (OR=4.92, 95% CI=2.75, 8.79, p<0.001) arms, with a significantly 
greater increase in the intervention arm (parmXtime<0.001) (Findings are currently under peer-review for 
publication). BreastScreen staff were highly supportive of the Health4Her intervention as part of 
routine care, however, the manually delivered intervention, dependent on dedicated human resource 
to administer, was considered unviable to implement in practice.  
As such, the overall aim of this study is to i) collaboratively design an automated alcohol brief 
intervention with women who participate in breast screening, ii) examine its effects on drinking 
intentions and alcohol consumption among women attending breast screening service for routine 
mammography and iii) understand the factors affecting intervention implementation using mixed-
methods program evaluation. 
 
3 
STUDY OBJECTIVES 
 
Our specific objectives are as follows: 
1. Collaboratively design an automated alcohol brief intervention (Health4Her-Automated; H4H-
A) with women who participate in breast screening and, after development, test the 
prototype, seek feedback, and refine the final product. 
2. Examine intervention effectiveness on drinking intentions, alcohol literacy and alcohol 
consumption among women attending a breast screening service for routine mammography. 
3. Evaluate the intervention’s reach, uptake, feasibility and acceptability. 
 
3.1 
RANDOMISED CONTROLLED TRIAL OUTCOMES/HYPOTHESES 
Primary outcome/hypothesis:  
a) Change in next-month drinking intentions (primary outcome): we hypothesise that there will 
be a greater change in the extent to which participants intend to reduce the amount of alcohol 
they consume among intervention participants, relative to control, between baseline and 
immediately post-intervention (likert scale response item) (15).  
Secondary outcomes / hypotheses: 
b) Change in next-month drinking intentions: we hypothesise that there will be a greater change 
in the extent to which participants intend to reduce the amount of alcohol they consume 

 
 
 
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among intervention participants, relative to control, between baseline and 4-weeks post-
intervention (likert scale response item) (15).  
c) Change in drinking intentions – standard drinks: we hypothesise that there will be a greater 
reduction in the intended number of standard drinks consumed over the next month among 
intervention 
participants, 
relative 
to 
control, 
between 
baseline 
and 
4-weeks 
(quantity/frequency response items) (16). 
d) Proportion of participants intending to reduce alcohol consumption: we hypothesise that there 
will be a greater change in the proportion of intervention participants, relative to control, 
intending to reduce their next-month alcohol consumption between baseline and 
immediately post-intervention (15). 
e)  Proportion of participants intending to reduce alcohol consumption: we hypothesise that 
there will be a greater change in the proportion of intervention participants, relative to 
control, intending to reduce their next-month alcohol consumption between baseline and 4-
weeks (15). 
f) Change in knowledge of alcohol as a breast cancer risk factor (alcohol-breast cancer literacy): 
we hypothesise that there will be a greater change in the proportion of intervention 
participants accurately identifying alcohol as a risk factor for breast cancer between baseline 
and 4-weeks, compared to control participants.   
g) Change in alcohol literacy: we hypothesise that there will be a greater change in the 
proportion of intervention participants, relative to control participants, accurately identifying 
the i) the increased breast cancer risk associated with drinking one average restaurant serve 
of wine a day; ii) number of standard drinks in an average restaurant serve of red wine; iii) 
maximum number of standard drinks per week recommended by current Australian Alcohol 
Guidelines between baseline and 4-weeks. 
h) Change in alcohol consumption: among women who have had an alcohol drink in the past 
month, we hypothesise that there will be a greater reduction in alcohol consumption among 
intervention participants relative to control participants, between baseline and 4- weeks. 
i) 
Change in knowledge of other breast cancer risk factors: we hypothesise that, in both 
intervention and control arms, there will be a significant increase in the proportion of 
participants accurately identifying inactivity and excess weight as risk factors for breast cancer 
between baseline and 4-weeks. (This represents a potential value-add of the intervention 
among women in the control group, and those who do not drink alcohol). 
 
4 
STUDY DESIGN 
 
This will be a hybrid type II effectiveness-implementation trial (17, 18) comprising a randomised 
controlled trial alongside a mixed-methods program evaluation, guided by applicable elements of the 
Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, 
Consolidated Framework for Implementation Research (CFIR) (19, 20) and Non-adoption, 
Abandonment, Scale-up, Spread, and Sustainability (NASSS) framework (21).  
 

 
 
 
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4.1 
COLLABORATIVE DESIGN OF H4H-A 
Study design: We will use an iterative, qualitative participatory design to co-produce and test the H4H-
A intervention and research procedures with breast screening service consumers. 
Setting: Researchers conducting collaborative design focus groups will be based at Turning Point, a 
national addiction treatment and research centre in Melbourne, Australia. Focus groups will be 
conducted onsite or online. 
Participants: Also utilised to inform our pilot trial, breast screening service consumers will be recruited 
predominantly from the Lifepool breast screening cohort (N=54,000) using systematic, purposive 
sampling to achieve representation of consumers from health inequity groups (e.g. rural, remote and 
regional consumers, CALD consumers).  
Data collection and analyses: Participatory co-design prioritises collaboration with target audiences 
to design successful products, systems, and services (22). A series of in-person and/or online 
collaborative design semi-structured workshops (incorporating ideas-generating and problem-solving 
activities) will be held with breast screen service consumers to identify issues related to automated 
alcohol brief intervention offered in the breast screening setting, and define what is needed to make 
a successful intervention. Ideas will be generated for intervention design, trial and dissemination in 
practice, to create and refine the intervention prototype and, after development, test the prototype, 
seek feedback, and refine the final product. Workshops will be audio-recorded, and transcribed 
verbatim. Workshop transcriptions, observations, and interactive data will be organised using NVivo, 
with data analysed using deductive thematic analysis. Interim data analyses and observations will 
feed-forward to subsequent workshops and inform intervention creation/testing. 
 
4.2 
RANDOMISED CONTROLLED TRIAL OF H4H-A 
Study design: A single site, double-blind, parallel-group randomised controlled trial, comprising 
baseline and 4-week follow-up assessments.  
Setting and participants: This trial will aim to recruit at least 78 participants (39 per trial arm). Women 
attending Maroondah BreastScreen for routine mammography (throughput ~65/screening day), aged 
40+ years, with or without a breast cancer history, and drinking at any level of alcohol consumption 
will be eligible to participate after they complete their screening appointment. Exclusion criteria: 
Women not able to read or comprehend English to enable participation, or who do not have access 
to computer, tablet or smartphone to complete the follow-up assessment, will be excluded from this 
iteration of the research. Women who are pregnant will be excluded (also an exclusion of breast 
screening). Women who participated in the previous Health4Her study will also be excluded (a woman 
can provide her name to the recruitment researcher for cross-checking against the previous 
participant list if she is unsure of previous participation. The same recruitment researcher that was 
onsite for the previous study will be onsite for this study. The researcher will exercise care to ensure 
security and privacy measures are used, i.e. the list will only include name and year of birth; the list 

 
 
 
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will be hosted on a secure server managed by Monash University eSolutions and accessible to only the 
recruiting researcher via a secure login; the list will never be shown to potential participants). 
Recruitment: Maroondah BreastScreen reception staff will provide a reminder text message one day 
prior to recruitment days to flag the study occurring onsite (as well as serving to confirm appointment 
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. 
Randomisation, interventions and procedure: The study will be described as the “Health4Her 
women’s health study” to minimise the salience of the trial’s alcohol focus, and to increase its 
relevance for all women. In the active and control arms, participants will be provided with an iPad and 
earbuds, and will self-complete consent (via a landing page) and baseline assessment before being 
randomly assigned (1:1 allocation ratio, utilising a “permuted blocks of variable size” scheme 
embedded in the iPad) to receive 1) ~4 minutes of alcohol brief intervention plus ~3 minutes of 
lifestyle information (active arm: H4H-A), or 2) ~3 minutes of lifestyle information not inclusive of 
alcohol information (control arm) via interactive animation. An assessment immediately post-
intervention will be completed on the iPad (comprising only the set of intention questions containing 
the primary outcome item). A 4-week follow-up assessment will be completed offsite via online 
survey, with the follow-up researcher prompting/assisting with survey completion when required.  
Alcohol brief intervention (active arm): Finalised through the collaborative design process, 
and based on brief intervention and applied behaviour change principles, the alcohol brief 
intervention will include information and behaviour-change content regarding alcohol 
consumption such as: messaging around alcohol risks/harms, positive-framed messaging on 
the health benefits of reducing alcohol intake, and behaviour change strategies (e.g. drink 
counting, goal setting, behaviour substitution, problem solving) (12, 23-26). This iteration of 
the research provides an opportunity to refine and add to the evidence-based intervention 
elements utilised in the pilot (e.g. provide the intervention in ‘chunks’, where the participant 
will view 1-2 minutes of animation before completing a brief activity such as setting goals or 
problem solving strategies), with the goal of strengthening intervention response. NB. H4H-A 
will be aligned with the National Health and Medical Research Council’s recently revised 
Australian Alcohol Guidelines (i.e. no more than 10 standard drinks per week, with the 
message ‘the less you drink, the lower your risk of alcohol-related harm’). Post-session 
information will be provided via email (i.e. an electronic brochure summarising alcohol brief 
intervention content).    
Lifestyle information (control and active arm): Finalised through the collaborative design 
process, potential elements will be: information on physical activity and maintaining a healthy 
weight, which can also reduce breast cancer risk (27, 28). Post-session information will be 
provided via email (i.e. an electronic brochure on nutrition for maintaining a healthy weight). 

 
 
 
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Implementation evaluation of a modified active arm: This 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. A theme from the previous program evaluation was 
that there may be some barriers to implementing the intervention onsite in practice, due to i) women 
not having time to complete the intervention onsite, and ii) there being not enough space to 
implement the intervention at smaller services. Therefore, a small group of women (n~20) who cannot 
participate on the day of screening (e.g. due to other commitments, paid parking timing out, etc. as 
identified in the previous study) will be offered to participate in the modified active arm offsite. 
Women who agree to take part in this element of the research will access the intervention after their 
appointment using their personal device (e.g. computer, iPhone, iPad) and will be offered a QR code 
before leaving the breast screening setting and/or sent a text/email following their appointment with 
the link to the Health4Her-Automated platform, to receive the participant information sheet, and 
complete verbal consent, baseline assessment and alcohol brief intervention. While the two-arm trial 
remains the main focus of this study (i.e. testing the benefits of an alcohol and lifestyle brief 
intervention offered to women attending breast screening, which can act as a window of opportunity 
to increase engagement with breast cancer risk reduction information), the addition of the modified 
active arm will permit evaluation of this alternative implementation approach.   
Power and sample size estimate:  
While this study will examine reach, uptake, feasibility and acceptability as important end-points, it 
will be powered to test the effectiveness of H4H-A in decreasing women’s drinking intentions. The 
sample size has been calculated using data from a previous, related study examining the effects of 
alcohol warning information about the alcohol-breast cancer link on drinking intentions (15). Using a 
Likert 5-point response scale (1 = not at all, 5 = to a very great extent, this study showed that the 
warning information, Alcohol increases your risk of breast cancer, increased participants’ intention to 
reduce the amount of alcohol they consume from a pre-exposure mean of 2.37 (SD = 1.18) to a post-
exposure mean of 2.63 (SD = 1.22).  
Given some differences in the previous study (i.e. the message about alcohol and breast cancer risk 
was not personally relevant to the whole sample comprising males and females 18-65 years; a single 
health message was provided, which is different to the Health4Her intervention containing several 
‘active ingredients’ based on alcohol brief intervention and applied behaviour change principles), we 
anticipate a greater increase in participants’ intention to reduce the amount of alcohol they consume 
in the current study. Further, based on our previous research, we anticipate some assessment 
reactivity among the control group.  
Power and sample size estimations were conducted using General Linear Mixed Model Power and 
Sample Size (GLIMPSE) software. We estimate (factoring in 5% attrition, and 30% of women attending 
breast screening who do not drink or have not drank in the past month) that a total sample size of at 
least 78 (39 per group) will have 80% power (α <0.05) (a total sample size of 90 [45 per group] will 
provide 85% power, α <0.05) to detect a change in women’s drinking intentions of 2.37 to 3.37 (change 
= 1.00) in the intervention group, and a change of 2.37 to 2.63 (change = 0.26) in the control group 
between baseline and immediately post-intervention. Therefore, this study will aim to recruit a total 

 
 
 
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sample size of at least 78 participants. Based on the barriers to participation and implementation 
identified in the previous phase of this research, the current study will provide an opportunity to 
collect some pilot data to inform scaled up research and implementation, to provide an indicator of 
outcomes for participants who complete a modified version of the alcohol brief intervention offsite 
using their own personal device (n~20). 
Statistical analyses: A full Statistical Analyses Plan will be developed prior to trial commencement. All 
statistical tests will be two-tailed, with the alpha level set to 0.05 and analyses conducted using the 
most appropriate procedures in Stata or R. All randomised participants will be included in the analyses 
(i.e. intention-to-treat) for primary and secondary outcomes. Analyses will examine change in 
outcomes over time (baseline, immediately post-intervention, 4-weeks). For intention outcomes, we 
will examine differences in responses according to baseline alcohol consumption risk status (i.e. 
drinking at a level within/exceeding current national alcohol guidelines). For alcohol outcomes, 
sensitivity analyses will be performed for women who a) report drinking any alcohol in the past month, 
and b) are identified to be drinking at a level exceeding current national guidelines for weekly and/or 
single day consumption. The Generalised Linear Mixed Model approach with fixed effects for 
treatment and time, and their interaction, and random effects for subjects and assessments within 
subjects, will be applied to examine the treatment effect of the intervention on all outcomes. 
 
 
4.3 
PROGRAM EVALUATION  
Study design: A comprehensive mixed-methods program evaluation will be undertaken utilising 
quantitative and qualitative data (i.e. trial / screening service administrative data, quantitative and 
qualitative feedback from trial participants, qualitative feedback from Maroondah BreastScreen staff). 
Participants: Quantitative feedback will be collected from all trial participants via the 4-week follow-
up online survey. Qualitative feedback will be collected from a subset of participants (semi-structured 
telephone interviews), site staff and managers involved in implementation (focus groups) post-trial. 
Program evaluation data collection and analyses: Summary statistics of trial administrative data (e.g. 
rate of uptake, engagement without assistance, level of assistance needed, reasons for 
nonparticipation, participant characteristics, rate of alcohol/breast cancer risk reduction information-
sharing with friends/family) will be presented. Applicable elements of the RE-AIM (20), CFIR (19) 
and/or NASSS (21) implementation research frameworks will be used to guide the development of 
semi-structured participant interviews and staff focus groups, and interpretation of feedback. 
Interviews and focus groups will be audio-recorded and transcribed verbatim. Data will be organised 
using NVivo, and analysed using deductive thematic analysis. 
5 
CONSENT   
 
5.1 
PARTICIPATION IN THE COLLABORATIVE DESIGN OF H4H-A 
For participation in a collaborative design workshop, researchers will provide a written (via email or 
post) and verbal explanation (aims, process, potential benefits and risks). Potential participants will 

 
 
 
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have the opportunity to discuss the study and ask questions. Participants will be advised that they can 
withdraw from the study at any time and that their decision whether to take part or not to take part, 
or to take part and then withdraw, will not affect their relationship with Eastern Health. The 
researcher will seek verbal informed consent from the individual to a) participate in the interview, and 
b) have their interview audio-recorded, with the understanding that the data they provide (i.e. what 
they say, demographic information provided) will only be used in an anonymised format (i.e. in such 
a way that they cannot be identified) in reports, publications and/or presentations that arise from this 
project. 
5.2 
PARTICIPATION IN THE RANDOMISED CONTROLLED TRIAL OF H4H-A 
For participation in the randomised controlled trial, an explanation of the trial will be embedded at 
the start of intervention participation (aims, process, potential benefits and risks). Participants will be 
advised via the embedded explanation 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. Potential participants will have the opportunity to discuss the trial with a researcher 
and ask questions.  
Women who are willing to take part will provide consent to participate in the study via check-boxes 
at the start of intervention participation. Participants will be asked to provide consent to the following 
items: 1) I consent to participate in the computer survey and receive health promotion as part of the 
“Health4Her women’s health study”. 2) I consent to participate in a follow-up survey via email in 4 
weeks’ time (a researcher can help me if I need). 3) I consent to participate in a telephone interview 
about the study, if I am selected to do so. 
A copy of the participant information sheet will be provided to the participant (link embedded at start 
of intervention, and emailed). 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. 
The randomised controlled trial component of this study necessarily requires limited disclosure 
including active concealment of the trial's alcohol focus. The trial will be described as the “Health4Her 
women’s health study” to minimise the salience of the trial’s alcohol focus, to a) increase its relevance 
for all women attending breast screening (so that women who drink alcohol are not singled out for 
participation), and to blind participants to group allocation. Participants will instead be informed that 
the study is concerned with promoting health across a range of lifestyle factors, which accurately 
corresponds to the intervention conditions (active = ~4 minutes of alcohol brief intervention plus ~3 
minutes of lifestyle information; control = ~3 minutes of lifestyle information not inclusive of alcohol 
information) and planned outcome assessments (comprising questions about diet, exercise, and 
alcohol). It is anticipated that participants will not be exposed to an increased risk of harm as a result 
of limited disclosure/concealment; this approach was endorsed by breast screening service consumers 
in our recently completed preliminary study of Health4Her.    

 
 
 
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5.3 
PARTICIPATION IN QUALITATIVE PROGRAM EVALUATION  
Participation in the qualitative component of the program evaluation involves a) the subset of trial 
participants invited to participate in a semi-structured telephone interview, and b) site staff and 
managers invited to participate in a focus group post-trial. Researchers will provide a written (via email 
or post) and verbal explanation (aims, process, potential benefits and risks). Potential participants will 
have the opportunity to discuss the study and ask questions. Participants will be advised that they can 
withdraw from the study at any time and that their decision whether to take part or not to take part, 
or to take part and then withdraw, will not affect their relationship with Eastern Health. The 
researcher will seek verbal informed consent from the individual to a) participate in the interview, and 
b) have their interview audio-recorded, with the understanding that the data they provide (i.e. what 
they say, demographic information provided) will only be used in an anonymised format (i.e. in such 
a way that they cannot be identified) in reports, publications and/or presentations that arise from this 
project. 
 
6 
STUDY PROCEDURES  
 
6.1 
STUDY FLOW CHART  
 
 
 
 
6.2 
SCHEDULE OF ASSESSMENTS 
  
Pre-trial 
Maroondah BreastScreen 
Online survey 
Time point:  
 
 
Assessment 
  
0 
(immediately 
pre-
intervention) 
1 
(immediately 
post-
intervention) 
2  
(4-weeks  
post-
intervention) 
COLLABORATIVE DESIGN OF H4H-A  
   In-person and online workshops with breast screening service  
   consumers 
x 
 
 
 
IMPLEMENTATION OF H4H-Aa 
   Eligibility assessment (breast screening staff will assess English  
   comprehension; question about access to computer, tablet or  
 
x 
 
 

 
 
 
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   smartphone embedded at start of intervention) 
   Trial explanation (embedded at start of intervention) 
  
x 
 
 
   PIS (link embedded at start of intervention, and emailed) 
  
x 
 
 
   Informed consent (embedded at start of intervention) 
  
x 
 
 
   Randomisation 
  
      x 
 
   Intervention 
  
      x 
 
   Measures 
 
 
 
 
     Primary outcome 
 
 
 
 
       Drinking intentions (5-point Likert scale) 
 
x 
x 
x 
     Secondary outcomes 
 
 
 
 
        Drinking intentions (QF intentions) 
 
x 
 
x 
        Alcohol-breast cancer literacy 
  
x 
 
x 
        Alcohol literacy 
 
x 
 
x 
        Alcohol consumption (past-month QF) 
  
x 
 
x 
        Knowledge of other breast cancer risk factors 
 
x 
 
x 
PROGRAM EVALUATIONa 
   Trial / service administrative data collection 
  
(throughout implementation) 
   Participant feedback 
  
(end trial) 
   Site staff and manager feedback 
  
(end trial) 
a Participants in the modified active arm being piloted will participate in eligibility assessment, informed consent, baseline, intervention, 
follow-up and program evaluation in the same way as participants in the active / control arms, but will not be randomised and will 
complete all activities offsite.  
 
7 
ASSESSMENTS 
Eligibility and baseline assessment will be self-completed on the iPad provided at Maroondah 
BreastScreen. The 4-week follow-up assessment will be self-completed online via a link sent by email 
or SMS (as preferred) Baseline and follow-up assessments will take 5-10 minutes to complete. 
7.1 
SCREENING MEASURES 
Standard demographic characteristics (e.g., age, gender, education level) will be recorded during the 
eligibility and baseline assessment, as well as information pertaining to the study’s inclusion and 
exclusion criteria.  
7.2 
OUTCOME MEASURES 
7.2.1 
PRIMARY OUTCOME MEASURE – DRINKING INTENTIONS 
Behavioural intention is considered in many health-behaviour models as being a necessary pre-
requisite for producing a behaviour (39). Specifically, intentions for alcohol consumption have been 
demonstrated to be important predictors of actual drinking behaviour (39). Drinking intentions will be 
measured using an adapted item from previous, related research (15), “Over the next month, to what 
extent do you intend to reduce the amount of alcohol you consume?” (5-point scale response option; 
1 ‘not at all’ to 5 ‘to a very large extent’).  
7.2.2 
DRINKING INTENTIONS 
Drinking intentions will also be measured using adapted versions of alcohol frequency/quantity 
items used in national alcohol intake surveys (40), i.e. intended frequency of alcohol consumption in 
the next month (categorical response item), intended type/number of drinks consumed on a typical 

 
 
 
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drinking day in the next month (visual drag and drop item). A composite value will be calculated 
from responses to these items, estimating intended standard drinks consumed in the next month. 
7.2.3 
KNOWLEDGE OF ALCOHOL AS A BREAST CANCER RISK FACTOR 
An item adapted from previous research in this research area (30) will be used to measure 
participants’ knowledge of alcohol as a breast cancer risk factor. Participants will be asked to rate six 
factors (family history of breast cancer, physical inactivity, antiperspirant deodorant use, alcohol, 
processed meats and being overweight) using a scaled-response option: 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 (31).  
7.2.4 
ALCOHOL LITERACY 
Alcohol literacy will be measured using three questions to ascertain knowledge of i) the amount of 
alcohol in an Australian standard drink, ii) the number of standard drinks in an average restaurant 
serve of wine, and iii) the maximum number of standard drinks per week recommended by current 
Australian Alcohol Guidelines (multiple-choice and free-text response items) adapted from previous 
literature (35). Alcohol-specific items will be nested among general health questions to conceal the 
focus on alcohol.  
As a measure of distributed alcohol literacy (36), a question ascertaining whether participants 
shared the health information they learned with others (e.g. family members, friends) will be 
included (binary response item). 
7.2.5 
ALCOHOL CONSUMPTION 
Alcohol consumption will be measured using adapted versions of alcohol frequency/quantity items 
used in national alcohol intake surveys (40), i.e. frequency of alcohol consumption during the past 
month (categorical response item), and type/number of drinks consumed on a typical drinking day 
during the past month (visual drag and drop item). A composite value will be calculated from 
responses to these items, estimating standard drinks consumed during the past month. This 
composite value will also be used to inform which normative feedback is provided in the brief 
intervention.  
7.2.6 
KNOWLEDGE OF OTHER BREAST CANCER RISK FACTORS 
Two questions will be used to measure participants’ knowledge of inactivity and excess weight as clear 
risk factors for breast cancer (scaled-response items) (37, 38). 
 

 
 
 
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8 
PARTICIPANT WITHDRAWAL 
8.1 
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 consent process and in the participant information sheet. 
If a participant wishes to withdraw consent, verbal or written (i.e. via email) 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. 
8.2 
LOSSES TO FOLLOW-UP 
Participants who have not completed the online survey and cannot be contacted after 5 phone 
calls/emails/SMS will be deemed to be lost to follow-up. 
 
9 
ADVERSE EVENTS AND RISKS  
9.1 
RISKS 
The risks of harm and discomfort to participants are anticipated to be minor and transient (e.g. some 
distress or discomfort may be experienced discussing health or health behaviours). Participants will 
be informed that if they wish to discontinue the study due to feelings of discomfort or distress, they 
can stop participating at any time. Participants will be provided with a list of support services that they 
can contact as needed. 
9.2 
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 general practitioner (GP) when required (GP details will be 
requested from the participant when this is deemed appropriate). Participants will be withdrawn from 
the study if any events compromise any existing treatment or their well-being.  
 
9.3 
Additional support and resources 
Participants will be advised (via the trial explanation embedded at start of intervention, and the 
participant information sheet) to contact their GP 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). 
The participant information sheet will contain the contact details for additional sources of support 
(e.g. Lifeline, DirectLine, CounsellingOnline).  
 

 
 
 
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10 DATA MANAGEMENT 
10.1 
DATA COLLECTION 
The Health4Her-Automated platform will comprise an electronic form that will be completed for each 
participant, and will contain participant information and study data. Developed by Action Lab 
(Department of Human-Centred Computing, Monash University), the project uses Google Cloud 
Platform (GCP) services, including Firestore, to handle electronic protected health information (ePHI). 
In order to meet the requirements of the Health Insurance Portability and Accountability Act (HIPAA), 
the project ensures the essential services, as outlined below, are appropriately configured following 
best practices: 
Access Controls and Authentication: Firestore provides robust access controls and authentication 
mechanisms to ensure that only authorised individuals can access ePHI. This includes features like 
Identity and Access Management (IAM), which allows granular control over who can access and 
manage Firestore resources. 
Encryption (Data security and protection): Firestore encrypts data at rest by default. Data are 
encrypted using Google's default encryption keys. 
Network and Infrastructure Security: Google Cloud employs various security measures to protect the 
infrastructure and network supporting Firestore. These include physical security controls, firewalls, 
network segmentation, and intrusion detection systems to safeguard against unauthorised access. 
Auditing and Monitoring: Firestore logs and audit trails are used to track access to ePHI and monitor 
system activities. It allows us to detect and respond to any security incidents or breaches promptly. 
Data Backup and Disaster Recovery: Automated data backups offered by Firestore are in place within 
the primary GCP resource location, which geographically resides in Australia (AUSTRALIA-
SOUTHEAST1 Sydney), for disaster recovery purposes.  
Ability to execute authorised and complete destruction of data: Firestore provides the ability to 
delete data both programmatically and through the project console. Deleting data (including its 
backups) will remove it from Firestore and data will not be recoverable. Data collected by the 
Health4Her web system will be retained for 5 years from the end of the collaboration. After this time, 
only non-identifiable data will be kept, indefinitely, as per Monash University policy and the Australian 
Code for the Responsible Conduct of Research (2018). 
Longevity of the systems within the cloud: GCP ensures that its services, ranging from computing 
engines to storage solutions, are designed for extended lifespans and minimal disruption. GCP ensures 
resilience and longevity through regular system updates, backward compatibility, and long-term 
support options. 
Prevention of unauthorised disposal: GCP offers robust access controls and logging mechanisms 
through its Identity and Access Management (IAM) service. Only authorised users will have access to 
the project and be able to perform deletion. Additionally, with Firestore's built-in audit trails via Cloud 
Audit Logs, every action performed on the data is logged, providing transparency and accountability. 

 
 
 
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The team will review these logs regularly (at least once per day) to help in detecting and acting upon 
any unauthorised disposal attempts. 
Protection of copyright and proprietary interests in data: GCP's terms of service, complemented by 
its robust security infrastructure, make it clear that users retain ownership rights to the data they 
store. Firestore, as a part of GCP, extends this principle, ensuring that data stored within its databases 
remains the intellectual property of the user. 
Data retrievability (while in the cloud): Firestore emphasises real-time data access and efficient 
querying, combined with the ability to export data snapshots to Google Cloud Storage for additional 
backup. Together, these tools and features ensure that user data is not only secure but also readily 
accessible and recoverable whenever needed. 
Extractability (if the service is discontinued): Firestore permits users to manually export their 
database contents to Google Cloud Storage, making data transfer and migration more streamlined. As 
such the team will have autonomy over the data and have ongoing access irrespective of the 
platform's future. 
Access Controls and Authentication: Firestore provides robust access controls and authentication 
mechanisms to ensure that only authorised individuals can access ePHI. This includes features like 
Identity and Access Management (IAM), which allows granular control over who can access and 
manage Firestore resources. 
Only approved members of the research team will have access to the data. While a unique identifying 
code will be generated for each participant in order to retain data integrity and manage data across 
time points, the platform will be used to collect all data for participants, which means that it will store 
identifiable data (i.e. name, contact information) as well as study data (i.e. participant responses to 
trial measures). However, identifiers will be flagged and will be removed from all data exports, to 
provide additional protection for these data elements. The data and identifiers will be accessible only 
to the Chief Investigator (Jasmin Grigg) and the Action Lab team members involved in platform 
maintenance during trial implementation, and the research assistants managing and cleaning baseline 
and follow-up data. On completion of data collection, non-identifiable trial data will be transferred 
from the platform to a statistical software package for analysis. 
Electronic 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 process evaluation during recruitment 
(e.g. keeping record of engagement without assistance, level of assistance needed, etc.), and b) 
managing follow-ups (e.g. keeping record of follow-up attempts, assistance with survey completion, 
etc.). These spreadsheets will only be accessed by the research assistants performing these roles, and 
will be password-protected and held on secure drives.  
Finally, all audio-recordings will be password-protected and held on a secure drive. Turning Point uses 
a professional transcribing company, Pacific Transcription, which complies with the Australian Privacy 
Principles contained in the Privacy Act 1988 (Cth), as well as the Guidelines on Privacy in the Private 
Health Sector issued by the Federal Privacy Commissioner under the National Health Act 1953 (Cth), 

 
 
 
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maintains a secure online website to uphold data security, and has all necessary safeguards in place 
to protect the information of research participants and uphold participant privacy and confidentiality. 
10.2 
DATA RETENTION 
All data collected during this study will be retained by the Investigator for a period of at least 5 years 
as outlined in the Australian Code for the Responsible Conduct of Research. 
 
11 STUDY OVERSIGHT  
11.1 
STUDY MONITORING  
The Investigators of this study have expertise relevant to the study and capacity to monitor the 
research team, monitor compliance with the protocol, monitor compliance with ethical and clinical 
governance, provide training and other means of quality control and assurance as appropriate, 
oversee trial arm fidelity, and provide necessary support to the research team. Regular liaison 
between the research staff and Principal Investigator will occur, and the broader research team will 
meet as needed. 
 
12 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 Good Clinical 
Practice as adopted by the Australian Therapeutic Goods Administration (2000) (CPMP/ICH/135/95) 
and the ICH GCP Guidelines. 
12.1 
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. 
12.2 
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. 
12.3 
PROTOCOL DEVIATIONS  
All protocol deviations must be recorded 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 study. 
12.4 
CONFIDENTIALITY 
The study will be conducted in accordance with applicable Privacy Acts and Regulations. All 
information regarding study participants will be treated in strict confidence. Data that identify any 

 
 
 
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study participant will not be revealed to anyone not directly involved in the collection and 
management of data for this study. 
12.5 
PARTICIPANT REIMBURSEMENT 
Participants of a collaborative design workshop will receive a $30 supermarket voucher. An incentive 
of a pledge of $10 to breast cancer research for trial participation (and an additional $10 pledge for 
qualitative program evaluation participation) will be used to optimise participation. 
12.6 
FINANCIAL DISCLOSURE AND CONFLICTS OF INTEREST 
The research is funded by Shades of Pink.  
12.7 
DISSEMINATION AND TRANSLATION PLAN 
Dissemination of findings to the research and clinical communities will be via peer-reviewed 
publications and conference presentations. Participants of the collaborative design component of this 
research will be informed they can access the Turning Point website for a summary report of research 
findings in 2024. The summary report of the trial will be made available to trial participants and non-
participating clients of Maroondah BreastScreen in 2024. Since limited disclosure including active 
concealment of the trial’s alcohol focus is necessary, the summary will include a full explanation of the 
trial’s aims and methods, and the reason why concealment was necessary.

 
 
 
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