Investigating the Use of Behavioural Science Informed Messages to Facilitate Attendance at Breast Cancer Screening
Phase: NA
Conditions: Breast Cancer
Sponsor: Imperial College London

 
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Investigating the use of behavioural science informed messages to 
facilitate attendance at Breast Cancer Screening 
 
 
 
 
Version 1.2 15/02/2022 
 
 
 
 
MAIN SPONSOR: Imperial College London  
FUNDERS: Imperial College London, NIHR Patient Safety Translational Research Centre 
STUDY COORDINATION CENTRE: xxx 
 
IRAS Project ID: 311717 
REC reference: xxx 
 
 
 
Protocol authorised by: 
 
Name & Role 
Date 
Signature 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Study Management Group 
 
Chief Investigator: Professor Ara Darzi 
 
Co-investigators: Amish Acharya, Gaby Judah, Hutan Ashrafian 
 
Statistician: Amish Acharya 
 
Study Lead: Gaby Judah 
 
Day-to-Day Study Management: Amish Acharya 
 
 
Study Coordination Centre  
 
For general queries, supply of study documentation, and collection of data, please 
contact: 
 
Study Coordinator: Amish Acharya 
Address: 10th Floor QEQM, St Mary’s Hospital, W2 1NY 
Registration:       
Tel: 02033126666/07811327985   
 
E-mail:  aa2107@ic.ac.uk 
 
 
 
 
 
 
 
 
 
Clinical Queries 
 
Clinical queries should be directed to Amish Acharya who will direct the query to the 
appropriate person 
 
Sponsor 
 
Imperial College London is the main research Sponsor for this study.  For further 
information regarding the sponsorship conditions, please contact the Head of 
Regulatory Compliance at: 
 
 
 
Research Governance and Integrity Team 
Imperial College London and Imperial College Healthcare NHS Trust 
Room 215, Level 2, Medical School Building 
Norfolk Place 
London, W2 1PG 
Tel: 0207 594 1862 
Imperial College - Research Governance and Integrity Team (RGIT) Website 
 
Funder 
 

 
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This work is being funded through an NHS England grant (London region) awarded 
to the study team at the NIHR Patient Safety Translational Research Centre 
(PSTRC). 
 
This protocol describes the study and provides information about procedures for entering participants.  
Every care was taken in its drafting, but corrections or amendments may be necessary. These will be 
circulated to investigators in the study.  Problems relating to this study should be referred, in the first 
instance, to the Chief Investigator.  
 
This study will adhere to the principles outlined in the UK Policy Frame Work for Health and Social Care 
Research. It will be conducted in compliance with the protocol, the Data Protection Act and other 
regulatory requirements as appropriate.  
 
Table of Contents                                                           
   Page No 
1. 
INTRODUCTION 
5 
1.1. 
BACKGROUND 
5 
1.2. 
RATIONALE FOR CURRENT STUDY 
6 
2. 
STUDY OBJECTIVES 
6 
3. 
STUDY DESIGN 
6 
3.1. 
STUDY OUTCOME MEASURES 
8 
4. 
PARTICIPANT ENTRY 
9 
4.1. 
PRE-REGISTRATION EVALUATIONS 
9 
4.2. 
INCLUSION CRITERIA 
9 
4.3. 
EXCLUSION CRITERIA 
9 
4.4. 
WITHDRAWAL CRITERIA 
9 
5. 
ADVERSE EVENTS 
9 
5.1. 
DEFINITIONS 
9 
5.2. 
REPORTING PROCEDURES 
10 
6. 
ASSESSMENT AND FOLLOW-UP 
10 
7. 
STATISTICS AND DATA ANALYSIS 
11 
8. 
REGULATORY ISSUES 
12 
8.1. 
ETHICS APPROVAL 
12 
8.2. 
CONSENT 
12 
8.3. 
CONFIDENTIALITY 
12 
8.4. 
INDEMNITY 
13 
8.5. 
SPONSOR 
13 
8.6. 
FUNDING 
13 
8.7. 
AUDITS 
13 
9. 
STUDY MANAGEMENT 
13 
10. 
PUBLICATION POLICY 
13 
11. 
REFERENCES 
13 
 
GLOSSARY OF ABBREVIATIONS 
BCT 
Behavioural Change Technique 
ICL 
Imperial College London 
NHS 
National Health Service 
NHSBSP 
NHS Breast Screening Programme 

 
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NHSE 
NHS England 
RCT 
Randomised Controlled Trial 
SMS 
Short Message Service 
 
KEYWORDS 
Breast cancer screening, uptake, behavioural science, SMS messaging 
 
STUDY SUMMARY 
 
TITLE Investigating the use of behavioural science informed messages to facilitate 
attendance at Breast Cancer Screening 
DESIGN Randomised Controlled Trial 
AIMS To determine the impact of SMS messages, and a video developed using 
behavioural science upon the uptake  
OUTCOME  
MEASURES 
Primary: percentage uptake of the invitation to screen. Secondary: percentage 
uptake of the invitation to screen amongst population subgroups (e.g. by 
demographic factors, and by invitation type). 
POPULATION All women aged between 50 and 70, invited to screen in the London breast 
cancer screening region. 
ELIGIBILITY Eligible to attend the NHSBSP in London during the study period.  
DURATION 6 months 
 

 
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REFERENCE DIAGRAM 
 
 
1. INTRODUCTION  
 
1.1. 
BACKGROUND 
 
Breast cancer is the most common cancer in the UK, with 1 in 8 women affected during their 
lifetime(1). Whilst survival rates are high, the 5-year survival rate is 72% higher with the 
earliest stage breast cancer, compared to the latest disease stage(2). The NHS Breast 
Cancer Screening Programme (NHSBSP) invites women aged 50 to 70 years old every 
three years to a mammogram. By enabling earlier detection, it is estimated that the NHSBSP 
saves 1300 lives per year(3).  
 
Despite the potential benefits of breast cancer screening, attendance is falling. Coverage 
rates have fallen nationally by 1.3% between 2016 and 2020. London has shown particularly 
poor rates (67.3%), with coverage in 2020 below the acceptable target of 70%(4). The 
COVID-19 pandemic has exacerbated these trends with an estimated 1 million 
mammograms missed, due to the cessation of screening to minimise transmission risk 
(5)(6). Counteracting these trends is a significant public health priority. 
 
Furthermore, there is increasing concern regarding the socio-demographic inequalities in 
breast screening uptake. For example, the odds of attendance amongst those from the most 

 
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deprived areas is 5% lower than those from less deprived areas (7)(8). In addition, in one 
study in London, the adjusted odds of attendance were almost three times higher amongst 
White British, compared to Asian women, and six times higher than Black women(9). The 
barriers faced by these groups need to be appreciated, and any intervention to increase 
attendance ensure that inequalities are not widened(10).   
 
Behavioural Science is a field of study concerning understanding the processes 
underpinning human action(11). Behavioural theories, such as the Capability Opportunity 
Motivation-Behaviour (COM-B) model (12, 13), have been used to understand the 
determinants of  several health behaviours including handwashing and smoking (14, 15). 
Recent studies have shown the application of behavioural science to screening may also 
facilitate uptake of invitations (16). In one study by Kerrison et al. the use of a reminder 
prompt SMS increased uptake by 5% (17). However, the use of plain text messages limits 
which behavioural determinants can be feasibly addressed, and what techniques can be 
used. Video messages can allow for more complex and a broader range of behavioural 
change techniques (BCTs) to be incorporated, and therefore have greater impact upon 
attendance. 
 
 
1.2. 
RATIONALE FOR CURRENT STUDY 
Whilst behavioural science-informed messages have previously been trialled by groups to 
facilitate breast screening attendance, their effectiveness has been variable (18). One of the 
reasons for this, is that SMS messages are of limited length and formatting capability, thus 
restricting the number of BCTs that can be included. Moreover, some behavioural techniques 
are more complex than others, and plain text can limit the extent to which these can be feasibly 
incorporated. Video messaging provides a delivery mechanism that may enable more 
complex, and different combinations to be trialled. There is however, a paucity of data 
regarding the impact of sending a video-based behavioural science message upon attendance 
rates at breast cancer screening programmes. This study looks to investigate the impact of a 
video-message, compared to behavioural science-based SMS messages and standard 
reminder SMS.  
 
2. STUDY OBJECTIVES 
 
The primary object is to determine the impact of behavioural science informed  (1) video and 
(2) SMS messages compared to usual care, upon uptake of breast cancer screening. 
Secondary objectives involve how this impact on attendance differs between population 
subgroups including people from differing demographic groups and people invited to open, 
as opposed timed appointments (see Study Design). 
 
3. STUDY DESIGN 
 
This study will be conducted as a randomised control trial (RCT) in the London screening 
region of the NHSBSP. The study will last over 6 months. The administrative hub for the 
NHSBSP in London is based at the Royal Free Hospital, who will oversee invitation 
scheduling, message delivery and outcome data collation through their existing delivery 
systems.  
 
Participants will be randomised using simple randomisation method in a 1:1:1 fashion to 
either intervention arm or usual care. Randomisation will utilise a computerised system in 
which each participant who is due for screening in the study period is randomly allocated a 

 
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number corresponding to the message they will receive. This will be undertaken by the 
screening hub, and will be passed on to the message delivery service who will ensure the 
correct template is sent. 
 
Written invitations are sent, as standard practice, by the NHSBSP to invite women to either 
(1) an appointment at a set time, date and location (so-called timed invitations) or (2) to call 
and book an appointment (or open invitation). Following this, as part of usual care, those 
selected for open invitations will receive a first SMS 7 days post written invitation. They will 
then receive two SMS reminders, 7 days and 2 days prior to the appointment, once it has 
been booked. Those who receive timed invitations will just receive the two reminder 
messages, 7 and 2 days prior to the appointment. The decision to offer an individual a timed 
or open invitation is made by the screening service based on their covid-19 recovery 
process, and will not be altered by this project. 
 
This RCT will involve randomising participants to receive the usual care messages 
(according to the timings outlined above), a plain text SMS incorporating BCTs or the BCT 
SMS with a new link to a video incorporating more BCTs (see figure 1 for message 
content in each of the three trial arms). 
 
The content of the intervention messages, and the video have been developed through 
extensive Patient and Public Involvement and Engagement work including 10 interviews, 2 
focus groups and 2 co-design workshops. Members of the public have been consulted 
throughout the process, especially regarding the representations of individuals in the video, 
and the message content. The feedback received has been used to alter the materials, and 
further feedback received. Through this iterative approach we have ensured content is 
appropriate. We have also sought feedback from members of the Oremi centre (a mental 
health day service specifically for African Caribbean and Arabic Speaking adults) and 
Gendered Intelligence (a trans-led organisation to improve the quality of life of trans people) 
to ensure individuals from these groups are happy with representations. Screening 
commissioners, led by Dr Kathie Binysh (NHS England Breast Screening Lead, London), 
have also approved this content. The NHS Identity team have provided approvals for the use 
of NHS logos/branding, and the team at London Northwest Healthcare NHS Trust approved 
the use of their name. 
 
The video will be hosted on a private page on the Imperial College London website, which 
will be available only to those who have been sent the link. The video will be translated into 
several languages, with voice overs also available in different languages, to ensure people 
from a diverse background are able to understand the content. 
 
After 3 months from the initial written invitations, data will be collated from the breast 
screening hub regarding whether an individual attended an appointment and whether the 
messages were successfully sent. This will be repeated at 6 months corresponding to the 
key performance indicator of the service. 
 
 
 
Figure 1. Message content for timed and open invitations for the trial arms (a) control, 
(b) plain text SMS with BCTs and (c) BCT SMS with new link to BCT video. 
 
 
 
 
Reminders at 7 and 2 days prior to appointment 
a) Control  
b) Behavioural SMS  
c) Behavioural SMS + Video  

 
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Don't forget your breast 
screening appointment is at 
10:36 am on 26/10/2021 at 
Edgware Community Hospital. 
To re-arrange or cancel your 
appointment call 0203 758 2024 
or visit www.london-
breastscreening.org.uk 
For further info please click 
here: 
https://youtu.be/7CAJqKnxKa4 
Following the breast cancer 
screening letter you received, 
don’t forget your appointment is 
at 10:36am on 26/10/2021 at 
Edgware Community Hospital.  
Detecting breast cancer early 
gives you the best chance to 
fully recover.  
To find out why we’re inviting 
you and what to expect watch 
this video: 
https://youtu.be/7CAJqKnxKa4  
To re-arrange or cancel your 
appointment call 0203 758 2024 
Following the breast cancer 
screening letter you received, 
don’t forget your appointment is at 
10:36am on 26/10/2021 at 
Edgware Community Hospital.  
Detecting breast cancer early 
gives you the best chance to fully 
recover.  
To find out why we’re inviting you 
and what to expect watch this 
video: https://imperial.ac.uk/ABBS 
To re-arrange or cancel your 
appointment call 0203 758 2024 
 
 
 
 
Message sent 7 days after the open invitation to book an appointment  
a) Control  
b) Behavioural SMS  
c) Behavioural SMS + Video  
Breast Screening appointments 
have changed. You will have 
received a letter on how to book 
an appointment. 
Please call the London Breast 
Screening Hub on 020 3758 
2024 or visit www.london-
breastscreening.org.uk to 
arrange an appointment at your 
nearest location. 
For further info please click 
here: https://youtu.be/7CAJqKnx
Ka4" 
 
Breast Screening appointments 
have changed.  You will have 
received a letter on how to book 
an appointment. Please call the 
London Breast Screening Hub 
on 020 3758 2024 or visit 
www.london-
breastscreening.org.uk to 
arrange an appointment locally. 
 
Detecting breast cancer early 
gives you the best chance to 
fully recover. To find out why 
we’re inviting you and what to 
expect watch this video: 
https://youtu.be/7CAJqKnxKa4 
Breast Screening appointments 
have changed.  You will have 
received a letter on how to book 
an appointment. Please call the 
London Breast Screening Hub on 
020 3758 2024 or visit 
www.london-
breastscreening.org.uk to arrange 
an appointment locally. 
 
Detecting breast cancer early 
gives you the best chance to fully 
recover. To find out why we’re 
inviting you and what to expect 
watch this video: 
https://imperial.ac.uk/ABBS 
 
 
3.1. 
STUDY OUTCOME MEASURES 
 
The primary outcome of this study is the percentage uptake of breast cancer screening, 
three months after the initial invitation letter. This will be reported as both intention-to-treat 
and per protocol, according to whether the SMS messages were received. Currently it is 
estimated that the screening service has access to 80% of mobile numbers of invitees.  
  
Secondary outcomes will involve how the uptake differs according to: 
 
 
- demographics (e.g. ethnicity, deprivation) 
 
- invitation type (open and timed invitation) 
 
- attendance history (previous non-attendee, recurrent attendee, first-time  
 
  invitee) 
 
We will also repeat the primary analysis to determine the uptake at 6 months. These 
timepoints were chosen firstly from the literature which suggests the impact of behavioural 
interventions occurs in the acute decision phase, but also following discussion with the 
screening service where 6 monthly reporting coincides with a key performance indicator. 

 
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4. PARTICIPANT ENTRY 
 
4.1. 
PRE-REGISTRATION EVALUATIONS  
As participants will be those invited as part of the NHSBSP, no additional pre-registration 
evaluations will be required. 
 
4.2. 
INCLUSION CRITERIA  
The inclusion criteria will match those used by the NHSBSP, as all invitations will come 
directly from the programme, as per usual care. These include: 
• 
Aged between 50 to 70 at the time of invitation 
• 
Lives within London screening region 
• 
Registered as female with GP  
 
4.3. 
EXCLUSION CRITERIA 
The exclusion criteria will match those used by the NHSBSP, as all invitations will come 
directly from the programme, as per usual care. These include: 
• 
Previous attendance at breast screening in the current (3-year cycle) 
• 
Opted out of receiving SMS messages 
• 
Opted out of screening  
• 
Previous bilateral mastectomy  
 
4.4. 
WITHDRAWAL CRITERIA  
As messages will be sent through the NHSBSP and undertaken as part of the usual care 
process the withdrawal criteria will match those of the screening service. Individuals can opt-
out of both messaging or screening at any time throughout the process and will be excluded. 
No data for those who highlight opt-outs will be held or analysed by researchers. The opt-out 
decision will be retained by screening services, and they will not be contacted with the 
messages. This process involves either indicating opt-out through the national data opt-out 
(should they wish not for their data to be used) or by contacting the London breast cancer 
screening service using the details provided on their invitation letter. Those who have opted 
out will not have data passed to researchers for analysis. However, following pseudo-
anonymisation it will not be possible for researchers to identify individuals who wish to have 
their data withdrawn.  
 
5. ADVERSE EVENTS  
 
5.1. 
DEFINITIONS  
Adverse Event (AE): any untoward medical occurrence in a patient or clinical study subject.   
 
Serious Adverse Event (SAE): any untoward medical occurrence or effect that: 
• 
Results in death 
• 
Is life-threatening – refers to an event in which the subject was at risk of death 
at the time of the event; it does not refer to an event which hypothetically might 
have caused death if it were more severe 
• 
Requires 
hospitalisation, 
or 
prolongation 
of 
existing 
inpatients’ 
hospitalisation 
• 
Results in persistent or significant disability or incapacity 
• 
Is a congenital anomaly or birth defect 
 

 
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Medical judgement should be exercised in deciding whether an AE is serious in other 
situations.  Important AEs that are not immediately life-threatening or do not result in death or 
hospitalisation but may jeopardise the subject or may require intervention to prevent one of 
the other outcomes listed in the definition above, should also be considered serious. 
 
5.2. 
REPORTING PROCEDURES  
All adverse events should be reported.  Depending on the nature of the event the reporting 
procedures below should be followed.  Any questions concerning adverse event reporting 
should be directed to the Chief Investigator in the first instance.   
 
5.3.1 Non serious AEs 
All such events, whether expected or not, should be recorded- it should be specified if only 
some non-serious AEs will be recorded, any reporting should be consistent with the purpose 
of the trial end points.  
 
5.3.2 Serious AEs 
An SAE form should be completed and emailed to the Chief Investigator within 24 hours.  
However, relapse and death due to breast cancer, and hospitalisations for elective treatment 
of a pre-existing condition do not need reporting as SAEs. 
 
All SAEs should be reported to the <name of REC> where in the opinion of the Chief 
Investigator, the event was: 
• 
‘related’, ie resulted from the administration of any of the research procedures; 
and 
• 
‘unexpected’, ie an event that is not listed in the protocol as an expected 
occurrence 
 
Reports of related and unexpected SAEs should be submitted within 15 days of the Chief 
Investigator becoming aware of the event, using the NRES SAE form for non-IMP studies.  
The Chief Investigator must also notify the Sponsor of all related and unexpected SAEs. 
 
Local investigators should report any SAEs as required by their Local Research Ethics 
Committee, Sponsor and/or Research & Development Office. 
 
Contact details for reporting SAEs 
RGIT@imperial.ac.uk 
CI email (and contact details below) 
Fax: xxx, attention xxx 
Please send SAE forms to: xxx 
Tel: xxx (Mon to Fri 09.00 – 17.00) 
 
6. ASSESSMENT AND FOLLOW-UP  
 
The end of the study will be 6 months after initiation. Following this period, we will undertake 
an assessment of the uptake of screening by participants. At two time-points (during and at 
the end of the study period) feedback from participants who have watched the video will be 
sought. This will involve anonymised feedback regarding an individual’s opinions on the 
content, characters, and style of the video. This feedback will be hosted on the video website 
and will be optional. Informed consent will be sought for the completion of this anonymous 

 
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questionnaire. The questionnaire is available at this link: 
https://imperial.eu.qualtrics.com/jfe/form/SV_1YPMnU1vvyeNDxA  
 
7. STATISTICS AND DATA ANALYSIS 
 
There will be three trial arms in this RCT. Based upon previous studies, and what would 
constitute a clinically meaningful effect size a power calculation has been conducted (18). 
Assuming 5% type 1 error probability, 80% power, and an effect size of 3%, results in a 
minimum sample size of 2797 people per study arm (8391 in total). Chi-squared non-
parametric statistic will be used to determine whether effects are significant. Secondary 
outcomes will examine the impact upon attendance amongst subgroups including those with 
different invitation type and from different demographic groups. A regression model will be 
developed to test these secondary hypotheses. 
 
Data flow for this project is demonstrated in figure 2.  
 
Figure 2 Demonstrating data flow of project. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Variables that will be extracted for analysis will include: 
 
1. Demographics 
• 
Age at invitation 
• 
Index of Multiple Deprivation (derived from postcode) 
• 
Ethnicity 
• 
Previous attendee/non-attendee/first-time invitee 
 
2. Invitation 
• 
Invitation type (open or timed) 
• 
Screening service location 
 
3. Outcome 
• 
Attendance at booked appointment 
 
Data Extraction from NBSS 
Pseudonymised 
Secure Data Transfer 
Analysis 
Breast Cancer 
Screening Hub 
at Royal Free 
Hospital 
Imperial College 

 
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Data and all appropriate documentation will be stored for a minimum of 10 years after the 
completion of the study, including the follow-up period.   
 
 
8. REGULATORY ISSUES  
 
8.1. 
ETHICS APPROVAL  
The Study Coordination Centre has obtained approval from the xxx Research Ethics 
Committee (REC) and Health Research Authority (HRA). The study must also receive 
confirmation of capacity and capability from each participating NHS Trust before accepting 
participants into the study or any research activity is carried out. The study will be conducted 
in accordance with the recommendations for physicians involved in research on human 
subjects adopted by the 18th World Medical Assembly, Helsinki 1964 and later revisions. 
 
8.2. 
CONSENT   
 
No consent will be sought from participants, as the act of alerting them to differing message 
contents can impact upon their behaviour and may bias results. For example, alerting 
participants to a breast screening project using messages to improve uptake, may act as a 
prompt for individuals who may have not attended to attend. Furthermore, there is a need to 
test such messaging as a population-level intervention, to see if it has an overall effect. Basing 
such testing on small groups that have explicitly consented, will likely bias findings, and ignore 
the impact upon under-represented groups. Moreover, the current project is simply changing 
the wording of messages and incorporating a different video intervention, which has been 
approved by NHSE. Screening services have the capacity to autonomously change the 
content of screening reminders, for example in response to fluctuating uptake or change health 
policies on a local level. Explicit consent therefore is not being sought for this project, as it 
does not diverge from the existing care that individuals currently receive. Not requiring consent 
is in keeping with existing projects that have received ethical approval and been conducted in 
England on the use of behavioural science messaging (16,17). 
 
On the other hand, written consent will be sought from the online feedback form for the video 
intervention. Participants will be free to withdraw from completing this questionnaire at any 
time, or not to undertake the survey at all should they wish. Consent to enter the study will be 
sought from each participant only after a full explanation has been given, an information leaflet 
offered, and time allowed for consideration.  An online participant consent will be obtained.  
The right of the participant to refuse to participate without giving reasons will be respected.   
 
8.3. 
CONFIDENTIALITY  
 
The Chief Investigator will preserve the confidentiality of participants taking part in the study 
and is registered under the Data Protection Act. 
 
Data will be pseudo-anonymised, with the code retained by the NHS Screening Service for 
their purposes, researchers will not have access to this so will not be able to de-anonymise 
data. It will be extracted from the NBSS system with identifiers removed and transferred to the 
Big Data Analytical Unit (BDAU) at Imperial College London for analysis. The BDAU is the 
data science facility within the Centre for Health Policy (CHP) at Imperial College. Its mission 
is to ensure the maximum use, impact and dissemination of research using healthcare data. 
Our secure environment (BDAU SE) was the first ISO 27001 certified research environment 
within the College. It is also 100% compliant with NHS IG Toolkit Version 14.1 (EE133887) 

 
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and holds a “Standards Met” status for DSP Toolkit (EE133887-BDAU). The BDAU has years 
of experience hosting and analysing sensitive healthcare data for research. These include 
datasets from CPRD, NHS Digital, NHS England, and NHS Improvement. 
 
8.4. 
INDEMNITY 
Imperial College London holds negligent harm and non-negligent harm insurance policies 
which apply to this study. 
 
8.5. 
SPONSOR  
Imperial College London will act as the main Sponsor for this study.  Delegated responsibilities 
will be assigned to the NHS trusts taking part in this study.   
 
8.6. 
FUNDING  
 The Patient Safety and Translational Research Centre (PSTRC) at Imperial College London 
will fund this study through an NHS England grant received by the research team. No 
renumeration will be provided to participants, as the sending of messages will encompass 
usual practice. Message costs above the existing limits will be covered by the research team 
to ensure the screening service does not incur a deficit due to this study. 
 
8.7. 
AUDITS   
The study may be subject to audit by Imperial College London under their remit as sponsor 
and other regulatory bodies to ensure adherence to GCP and the UK Policy Framework for 
Health and Social Care Research.  
 
 
9. STUDY MANAGEMENT  
 
The day-to-day management of the study will be co-ordinated through Amish Acharya.   
 
 
10. PUBLICATION POLICY  
 
A robust publication policy is envisaged with aggregated unidentifiable data published in peer 
review journals and in conference presentations. To ensure widespread dissemination of the 
work to relevant stakeholders, dissemination will also include non-academic means such as 
blog posts. This work will also be incorporated into a PhD thesis. No identifiable data will be 
used in any publication. 
 
 
11. REFERENCES  
1. 'Cancer Research UK. Breast cancer statistics [Internet]. 2015 [cited 2021 Dec 1]. 
Available from: https://www.cancerresearchuk.org/health-professional/cancer-
statistics/statistics-by-cancer-type/breast-cancer 
 
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