Evaluation of Acceptance and Usability of an App Promoting Healthy Behaviours Amongst Young Women at Increased Risk of Breast Cancer
Phase: NA
Conditions: Breast Cancer, Overweight and Obesity, Diet, Healthy, Weight Gain, Alcohol Drinking, Smoking Behaviors, Healthy Nutrition, Healthy Lifestyle, Healthy Eating Index
Sponsor: University of Manchester

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Research Protocol: Acceptance and usability of the healthy behaviours app                                                          Page 1 of 23 
RESEARCH PROTOCOL 
 
 
 
 
 
 
 
Evaluation of acceptance and usability of an app promoting healthy behaviours 
amongst young women at increased risk of breast cancer 
 
 

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Contents 
 
 
1) 
RESEARCH TEAM & KEY CONTACTS 
3 
2) 
INTRODUCTION 
5 
3) 
BACKGROUND 
5 
4) 
STUDY OBJECTIVES 
7 
5) 
STUDY DESIGN & PROTOCOL 
7 
6) 
STUDY PARTICIPANTS 
11 
7) 
OUTCOME MEASURES 
15 
8) 
DATA COLLECTION, SOURCE DATA AND CONFIDENTIALITY 
16 
9) 
STATISTICAL CONSIDERATIONS 
17 
10) DATA MONITORING AND QUALITY ASSURANCE 
18 
11) SAFETY CONSIDERATIONS AND ADVERSE EVENTS 
19 
12) PPI INVOLEMENT 
19 
15) PANDEMIC CONTINGENCY PLAN 
20 
16) PEER REVIEW 
20 
17) ETHICAL AND REGULATORY CONSIDERATIONS 
21 
18) STATEMENT OF INDEMNITY 
21 
19) FUNDING and RESOURCES 
21 
20) PUBLICATION POLICY 
21 
21) REFERENCES 
21 
 
 
 
 
 

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1) RESEARCH TEAM & KEY CONTACTS  
Chief Investigator: 
 
Name:     Mary Pegington 
 
Address:   The Nightingale Centre, Wythenshawe 
Hospital, Manchester University NHS Foundation 
Trust, M23 9LT 
 
Email: mary.pegington@manchester.ac.uk  
 
Telephone: 0161 2914412 
 
 
Co-investigators: 
 
Name:     Dr Michelle Harvie 
Address:   The Nightingale Centre, Wythenshawe Hospital, 
Manchester University NHS Foundation Trust, M23 9LT 
Email: michelle.harvie@manchester.ac.uk  
 
Name:    Dr Alan Davies 
Address:   Division of Informatics, Imaging & Data Sciences, 
School of Health Sciences, Faculty of Biology, Medicine & 
Health, The University of Manchester, Vaughan House, 
Portsmouth St, M13 9GB 
Email: alan.davies-2@manchester.ac.uk 
 
Name:    Dr Julia Mueller 
Address:   Prevention of Diabetes and Related Metabolic 
Disorders, MRC Epidemiology Unit, University of Cambridge, 
CB2 0QQ 
Email: Julia.Mueller@mrc-epid.cam.ac.uk  
 
Name:     Professor David French 
Address:   Division of Psychology and Mental Health, School 
of Health Sciences, Manchester Centre of Health Psychology, 
University of Manchester, Coupland 1 Building, Oxford Road, 
Manchester, M13 9PL  
Email: david.french@manchester.ac.uk 
 
Name:     Professor Anthony Howell 
Address:  Division of Cancer Sciences, School of Medical 
Sciences, University of Manchester, Manchester Cancer 
Research Centre/Oglesby Cancer Research Building, The 
Christie NHS Foundation Trust, 555 Wilmslow Road, M20 4GJ 
Email: anthony.howell@manchester.ac.uk 
 
Name:     Professor D Gareth Evans 
Address:  Division of Evolution, Infection and Genomics, 
School of Biological Sciences University of Manchester, St 
Mary's Hospital, Manchester University NHS Foundation 
Trust, Oxford Road, Manchester, M13 9WL 
Email: gareth.evans@mft.nhs.uk  
 
Name:     Dr Sacha Howell 
Address:  Medical Oncology, Division of Cancer Sciences, 
School of Medical Sciences, Faculty of Biology, Medicine and 
Health, The University of Manchester, Oglesby Cancer 
Research Centre, Manchester, M20 4GJ 
Email: sacha.howell@nhs.net  
Study Management Group: 
Mary Pegington, Michelle Harvie, Alan Davies, Julia Mueller, David French, Anthony Howell, Emily Smith (PPI 
participant). 
 

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Sponsor: 
 
Name: The University of Manchester  
 
Sponsor contact: Ms Lynne Macrae, Faculty 
Research Practice Governance Coordinator 
 
Address:  
Faculty of Biology, Medicine and Health  
5.012 Carys Bannister Building  
University of Manchester 
M13 9PL 
 
Email: FBMHethics@manchester.ac.uk 
 
Telephone: 0161 275 5436 
 
Lead R&D Trust contact(s): 
 
Name:     Manchester University NHS Foundation 
Trust (MFT) 
 
Contact: Elizabeth Mainwaring, Research 
Operations Manager 
 
Address:  
Research Office 
1st floor 
The Nowgen Centre 
29 Grafton Street 
Manchester 
M13 9WU 
  
Email: R&D.applications@mft.nhs.uk 
 
Telephone: 0161 276 3340 
 
 

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2) INTRODUCTION 
It is estimated that around 20% of breast cancers (BC) in the UK are preventable through adherence 
to appropriate health behaviours, i.e., healthy diet, physical activity, limited alcohol, not smoking, 
and that women at increased risk of BC could benefit from greater decreases in risk than the general 
population via health behaviour changes.  Young women (age <35 years) who are at increased risk 
of developing BC currently receive little or no information regarding health behaviours and BC risk, 
or support for behaviour change.  This feasibility study aims to explore whether a novel app is 
acceptable to women at increased risk and could potentially engage them with improved health 
behaviours which could reduce their future risk of BC. 
 
 
3) BACKGROUND  
The importance of health behaviours for BC prevention 
Breast cancer (BC) is the most frequent female malignancy worldwide, with over two million 
diagnoses annually worldwide and over 55,000 diagnoses in the UK1.  These figures are predicted to 
increase2.  
 
Recent overviews estimate potentially modifiable health behaviours to be responsible for a high 
proportion of BC in the UK (~20%)3.  Overweight/obesity and weight gain through adulthood are 
responsible for around 8%, 8% is associated with alcohol intake, while not breastfeeding is 
responsible for 5%3.  Other health behaviours that increase risk include smoking and lack of physical 
activity (PA)4. Each 5 kg gain in weight in adult hood is associated with a 6% increased risk in post-
menopausal BC (RR 1.06 [95% CI 1.05-1.08])4.  
 
A significant proportion of BC cases, around 38%, occur in the 18% of women who are at increased 
risk (>17% lifetime risk) due to family history, mammographic density and single nucleotide 
polymorphisms (SNPs)5.  Health behaviours have been shown to increase risk to an equal or greater 
extent in women with a family history of BC compared to those without. Prospective data from 
combined studies in Australia, US and Canada (n=15,550) found higher levels of PA reduced BC risk 
similarly in women with and without a FH of BC6. The US Women’s Health Initiative – Observational 
Study (n=85,644) found that adhering to three ‘breast healthy’ behaviours of <7 alcoholic drinks per 
week, >100 minutes moderate/vigorous exercise per week and maintaining healthy range BMI 
(18.5-24.9 kg/m2) at baseline and throughout non-pregnant adulthood was similarly associated with 
a lower BC risk for women with family history of later onset (>45 years) BC and for those without7.  
Analysis of UK Generations Study data (n=102,927) showed that smoking increases relative risk 
more in women with a family history of BC compared to women without8. An Australian cohort 
study (n=16,035) found that overweight and obesity has a greater proportional effect on increasing 
BC risk amongst women already at increased risk due to family history compared with women from 
the general population.  They concluded by stating “maintaining a healthy weight throughout adult 
life is of clinical significance for all women, and especially those with a family history of breast 
cancer”9.  Targeting health behaviour interventions to women at increased risk of BC could have a 
significant impact on reducing rates because even the same relative reduction in risk will lead to 
greater absolute reductions. 
 
Current health behaviours amongst women at increased risk 
Many women known to be at increased risk attend Family History, Risk and Prevention Clinics 
(FHRPCs) of which there are around 90 in the UK, including our own based at The Nightingale Centre, 

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Wythenshawe Hospital, Manchester University NHS Foundation Trust (MFT).  According to NICE 
guidance, FHRPCs should provide advice on health behaviours to lower BC risk10 but few do in 
practice due to limitations on time, skills and resources. Analyses of BMI and health behaviour data 
from women at increased risk (mean age 41.2, SD 3.5 years) in our clinic at The Nightingale Centre 
highlighted the prevalence of unhealthy health behaviours which were comparable to the general 
population, i.e. almost 60% had overweight or obesity, 30% did not meet physical activity 
recommendations, and 45% exceeded alcohol recommendations11.  Thus, there is an unmet need 
to provide cancer prevention health behaviour programmes for women at increased risk. 
  
We have previously shown that significant weight gain occurs between the ages of 18 and 35 years 
in women12.  Once weight is gained, it is very difficult to lose.  This project is focussed on women 
aged <35 years to improve health behaviours and try to prevent weight gain in this population at 
increased BC risk, rather than deal with weight problems once they have occurred. 
 
The need for a health behaviour app 
Our interview study amongst women at increased risk aged 25-35 years from our FHRPC showed 
these women were interested in joining a programme to promote health behaviours and prevent 
weight gain which was accessed via an app13. Further Public and Patient Involvement (PPI) work with 
women aged 25-35 years from our FHRPC who had been a healthy weight at age 18 years but had 
since gained at least a stone in weight also showed support for an app.  
 
Whilst there are a number of apps already on the market that aid weight loss there are currently no 
apps designed to prevent weight gain.  A search of the literature revealed no publications on 
development of such apps, therefore there is nothing that is currently suitable for testing in FHRPCs. 
There are many BC information and prevention apps which only provide static information, for 
example on risk factors and health behaviour advice.  None are interactive and grounded in 
recognised psychological theory; therefore they are unlikely to elicit behaviour change. The content 
of such apps has not been reviewed but a brief look at descriptions on the Google Play store 
indicates that they are not likely to be evidence-based, for example “Breast Cancer” app contains 
details of ‘foods that cause breast cancer’, “Breast Cancer Stages, Signs, Food and Meal Plan” app 
contains ‘30 foods [to] reduce breast cancer risk’, and “Breast Cancer Guide” app states that ‘85% 
of all breast cancer cases are caused by factors other than heredity, such as environmental toxins, 
bad eating habits, and stress’.  This conflicts with current evidence about modifiable BC factors 
mentioned above. 
 
Development of the current app 
We have developed an app using a co-design process involving young women from the FHRPC. Our 
multi-disciplinary team has previous experience of developing health apps. Inclusion of behavioural 
psychologists with expertise in developing digital health interventions in our project team has 
ensured that the app is grounded in psychological theory therefore more likely to be effective.  
 
The aim of the app is to improve health behaviours, i.e. healthy eating, alcohol, PA, smoking 
cessation and breastfeeding, and prevent weight gain.  The app includes encouraging self-
monitoring and goal setting, and provides education.  Social/peer support is provided via a private 
Facebook group. 
 
Testing the complex intervention 

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Evidence generation will follow “Evidence Standards Framework for Digital Health Technologies” 
guidance by NICE14 to evidence tier 3a, for example involving experienced health professionals in 
the app, design, development and testing, involving users with acceptability testing (the purpose of 
this study), ensuring content is accurate and up-to-date, and demonstrating its effectiveness.  This 
will help to ensure that the correct evidence is gathered to enable future use of the app in the NHS.  
The intervention is “complex” as it has a number of interacting components (information provision, 
social/peer support, goal setting) and a number of outcomes (weight, alcohol, PA, healthy eating, 
smoking)15.  Therefore we will follow “Developing and evaluating complex interventions: the new 
Medical Research Council guidance”15.  This study forms part of assessing feasibility before the 
evaluation phase. 
  
4) STUDY OBJECTIVES  
 
4.1. Aims 
1. To assess the acceptability and usability of the app to young women at increased risk of BC 
2. To assess the feasibility of study procedures before running a future efficacy study using the 
app as an intervention 
 
4.2. Objectives 
1. Explore views of users of the experiences during and after using the app  
2. Explore views of users on their experience of the two different recruitment procedures 
(targeted mailshot, or social media, newsletters and websites), and the online consent 
procedure. 
3. Interpret user data from the app including frequency and patterns of use of the different 
functions 
4. Analyse recruitment data to explore how the two different recruitment procedures could 
be improved for the next study 
5. Assemble a list of suggested changes to recruitment and consent procedures, and to the 
app, to be considered before the next study. 
6. Quantify health care professional (HCP) time required for administering the private 
Facebook chat group, and through e-mail/private message support. 
7. Quantify researcher time required for cleaning and analysis of app data. 
 
 
5) STUDY DESIGN & PROTOCOL 
5.1 Participants 
The study will recruit 35 young women (≤35 years) who are at increased risk of BC. 
 
5.2 Study Intervention and/or Procedures 
The participant journey is as shown in Figure 1.  Procedures are listed in Table 1.  
 
 
 

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Figure 1: Participant journey  
 
 
 
 

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Table 1: List of participant procedures. 
Procedure 
Frequency and time 
point(s) 
Duration 
Location 
Receives participant 
information sheet (PIS) 
x1 at recruitment 
15 minutes to 
read 
In post, or by e-mail. 
Location of reading it is 
participant’s choice. 
E-mails study team so show 
interest 
x1 at recruitment 
2 minutes 
Online: location is 
participant’s choice. 
Phone call from study team 
to check eligibility and 
explain next steps 
x1 at recruitment 
20 minutes 
Participant’s choice based 
on their chosen time, e.g. 
home, work. 
Completion of online 
consent 
x1  
10 minutes 
Online: location is 
participant’s choice. 
Receives e-mail with their 
unique study ID and links to 
download app, join private 
Facebook group and 
complete questionnaires as 
below. 
x1 
1 minute 
Online: location is 
participant’s choice. 
Download and set up app 
x1 
15 minutes 
Location is participant’s 
choice. 
Follow invite link to join 
private Facebook group 
Optional x1 
5 minutes 
Location is participant’s 
choice. 
Completion of Demographics 
and Health Behaviours 
Questionnaire 
x1 after consent 
(baseline) 
10 minutes 
Online: location is 
participant’s choice. 
Completion of BC risk beliefs 
questionnaire 
x2 after consent 
(baseline) and at 2 
months  
10 minutes 
Online: location is 
participant’s choice. 
Completion of Mobile 
Application Rating Scale 
(uMARS)16 questionnaire 
x2 at 1 and 2 months 
10 minutes 
Online: location is 
participant’s choice. 
MS Teams starter group 
session 
Optional x1 after baseline 
questionnaires submitted 
45 minutes 
MS Teams: location is 
participant’s choice. 
Submit health behaviour logs x0-8 depending on 
chosen frequency 
(between weekly and 
monthly) 
10 minutes 
Via app: location is 
participant’s choice. 
Read posts on private 
Facebook group and post or 
‘react’ (e.g. like) to the posts 
of others (optional) 
Optional 0+ after joining 
Facebook group 
1+ minutes 
Via private Facebook 
Group: location is 
participant’s choice. 
Completion of app feedback 
questionnaire 
Optional x1+ as and when 
wishes to give feedback 
on app during study 
5 minutes 
Online: location is 
participant’s choice. 
Read educational material 
on app 
x0-8+ depending on 
chosen frequency 
10 minutes  
Via app: location is 
participant’s choice. 

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Qualitative interview – up to 
20 women (optional and if 
invited) 
Optional x1 after study 
completion 
1 hour 
Patient choice (home or 
remote via MS Teams or 
phone) 
Receive and read 
questionnaire reminder e-
mail if doesn't complete a 
questionnaire after ~3 days 
0-5 
1 min 
Location is participant’s 
choice. 
Receive a questionnaire 
reminder phone call if 
doesn't complete a 
questionnaire after ~5 days 
0-5 
5 min 
Location is participant’s 
choice. 
 
5.3 Questionnaires 
All questionnaires will be hosted on Qualtrics.  Non-responders will receive an e-mail reminder 3 
days after questionnaire is due, and a telephone reminder after 5 days.  These durations may change 
due to weekends and holidays. 
 
5.4 Prevent: The Healthy Living App 
The app was built by software developers in ResearchIT at the University of Manchester and includes 
self-monitoring of health behaviours, goal setting, education and feedback.   
 
5.5 The Private Facebook Group 
Membership of the private Facebook group is by invite only and the account will be set to only allow 
invitation by the group administrator(s).  Upon receiving an e-mail invite, participants can request 
to join and the group administrator(s) will then approve the participants’ request.  Participants will 
join using their personal Facebook account.  The Facebook group is ‘private’ meaning that only 
invited members can see what members post, comment on and share within the group, and only 
invited members can see the list of members in the group.  The Facebook group is also ‘hidden’ 
meaning that only current, invited or former members of the group can see the group’s name and 
description, and can find the group in search, and only former members of the group can request 
to join. The participant’s membership of the group and any posts they make within the group are 
not visible on their profile.  However, this is a group chat and comments written will be visible by all 
other members of the study who have joined the private group and participants will be reminded 
of this and also that no personal details (e.g. address, family details) should be posted. University of 
Manchester “Social Media and CCTV – Guidelines for use in research” (display.aspx 
(manchester.ac.uk)) will be followed.  Any participant posting inappropriate content or comments 
will be removed from the group by the administrator, contacted by e-mail explaining why they have 
been removed, but will be allowed to remain in the study. 
 
A post about the weekly educational topic will be added to the Facebook group once a week.  This 
could be, for example, a poll or request for recipe exchange.  The moderator(s) will check the group 
at least once daily including weekends and reply to comments and private messages. 
 
5.6 Qualitative study plan  
We will undertake up to 20 semi-structured interviews at the end of the two month study. Sampling 
will be purposive, aiming to obtain women with a range of ages and ethnicities.  
 

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The interviews will be conducted by a University of Manchester qualitative health psychology 
researcher and the topic guide has been produced in conjunction with the research study team. 
Interview data will be digital audio-recorded (using encrypted audio recorder for phone and face-
to-face interviews and Microsoft Teams audio recording facility for interviews held on Microsoft 
Teams) and downloaded to secure University of Manchester drives as soon as possible, and deleted 
from the device and Teams account.  They will be transcribed verbatim using a University of 
Manchester approved professional transcription service.  We will follow University of Manchester 
guidance: “Taking recordings of participants for research purposes SOP (The University of 
Manchester)”.  The transcription service have signed an agreement with the University which 
includes confidentiality clauses.  Transfer of recordings to the transcription service will be in line 
with University of Manchester guidance which allows the use of either University of Manchester 
Dropbox Service or Zendto. 
 
The Interview schedule contains a list of questions to be discussed in this study. The work will remain 
flexible with respect to participants’ commitments, but we will cover the main topics outlined 
below. It is common in qualitative data collection methods to develop topics and questions as new 
ideas emerge from early data collection. Therefore, we may add new questions and refine topics as 
the interviews progress and data collection continues thus improving participant understanding of 
questions/understanding participant experiences fully.  
 
The focus of these interviews is to explore participants’ experience of using the app, the usability of 
this app, whether it has been useful to them in changing their health behaviours (e.g. healthy eating, 
PA, alcohol intake), and understand how the app may have influenced health behaviours or feelings 
towards breast cancer.  
 
5.7 End of Study Procedures 
The end of the study is defined as when the last participant has completed their interview.   
 
Weekly educational information within the app, and associated post of the private Facebook group 
will continue until all participants have had two month access to the app.  Once all interviews are 
complete, all participants will be e-mailed to inform them that the study is complete, any entries 
they make in the app will no longer be monitored, and all participants will be removed from the 
private Facebook group. HCP monitoring of the private Facebook group will happen until this point.  
It is not possible to withdraw access to the app from participants’ phones.  Access to the app and 
private Facebook group will continue beyond two month access so that participants can still access 
at the time of their interview. 
 
In the case of premature study closure, participants will be informed by e-mail and in a post on the 
private Facebook group after which access to the private Facebook group will be withdrawn. 
 
 
6) STUDY PARTICIPANTS 
6.1 Inclusion Criteria:  
• 
Female 
• 
Age 18-35 years 
• 
Live in the UK 
• 
Moderate or high risk of BC (see 6.5 for definition) 

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• 
Ability to communicate in English 
• 
Ability to download and use an app (available on both ioS and Android) 
 
 6.2 Exclusion Criteria:  
• 
Previous BC (other cancers will not be excluded) 
• 
Previous preventative mastectomy 
• 
Currently trying to gain weight 
• 
Previous weight loss surgery 
• 
Currently taking weight loss medication, prescribed (for example orlistat, liraglutide, 
Naltrexone/Bupropion [Mysimba]) or other 
• 
Have a medical condition that influences diet and weight, for example, diabetes, 
inflammatory bowel disease or cystic fibrosis 
• 
Current diagnosis of a psychiatric disorder, for example bipolar psychotic disorder or current 
self-harm 
• 
Current alcohol or drug dependency 
• 
Current or previous diagnosis of an eating disorder 
 
6.3 Recruitment:  
Participants at moderate or high risk of BC will be recruited in 2 different ways: 
• 
Receiving a targeted mailshot from the FHRPC – cover letter and PIS 
• 
Viewing advertisement on Prevent Breast Cancer website/newsletter or on other websites 
and social media platforms such as Facebook and Twitter. 
 
Recruitment from within the FHRPC 
We have previously successfully recruited to research studies using mailshots to FHRPC participants.  
Other methods of recruitment will be used to expand diversity within the recruited population as it 
is known that the ethnicity of clinic attendees is mainly white.  We aim to recruit around 30 women 
via the FHRPC mailshot and around 5 women from outside of the FHRPC via novel methods to make 
up the cohort of 35 women. 
 
Invitation letters will be sent from the FHRPC at MFT only to women recorded as being moderate or 
high risk on the FHRPC database (≥17% or 1 in 6 lifetime risk).  Based on previous experience 
regarding study recruitment using mailshot within the FHRPC a 15% uptake is expected therefore 
200 letters will be posted to recruit 30 women. There are currently >1,000 women <35 years on the 
FHRPC database.  Should recruitment not have been achieved within 4 weeks, a further mailshot 
will be done with the aim of completing recruitment.  The number of letters posted will be based 
on the percentage uptake figure so far achieved. 
 
Recruitment from outside of the FHRPC 
Advertising on social media will follow University of Manchester “Social Media and CCTV – 
Guidelines for use in research” (display.aspx (manchester.ac.uk)), i.e. a personal account will not be 
used and specific individuals will not be targeted for recruitment.  Interested potential participants 
will be asked to contact the study team by e-mail and will receive the PIS or can view it via the 
ISRCTN website where it will be attached to the study record.   
 
All potential recruits 

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A date/time for telephone eligibility check will be organised by e-mail for completion of Screening 
Proforma.  This phone call will be with Mary Pegington (Research Dietitian and study CI) to check 
eligibility and explain the study process.  They will be asked if they have read and understood the 
PIS.  There will be ample opportunity within this call for potential participants to ask questions. If 
they are interested in proceeding they will be e-mailed instructions to complete online consent 
(together with a Word document listing the questions that will be on the consent form that they 
can keep for their records), after which they will be provided links to download the app and 
complete the online questionnaires. We will ensure that there are at least 24 hours between 
receiving the PIS and receiving the link for the consent form by e-mail. In the intervening time there 
will be a telephone conversation to check eligibility and answer any questions. 
 
In order to report uptake to the study and reasons for screen fail, if participants are not eligible we 
will ask if we can keep the answers they have given to the eligibility questions and record their verbal 
consent.  With their consent we will complete all of the eligibility questions with them.  By doing 
this we will identify and report multiple reasons for screen failure. We will not keep their name so 
that the information is anonymised.  If they do not consent to us keeping this anonymous 
information we will destroy it. 
 
6.4 Recruitment of women from outside of the FHRPC 
Women recruited from outside of the FHRPC will be accepted if they meet the criteria for referral 
to Secondary Care as detailed in section 1.3.3 of NICE Clinical Guideline 164 “Familial breast cancer: 
classification, care and managing breast cancer and related risks in people with a family history of 
breast cancer”10.  Women without a personal history of BC meeting the following criteria will be 
eligible:  
• 
one first-degree† female relative diagnosed with BC at <40 years or 
• 
one first-degree male relative diagnosed with BC at any age or 
• 
one first-degree relative with bilateral BC where the first primary was diagnosed at <50 
years or 
• 
two first-degree relatives, or one first-degree and one second-degree* relative, diagnosed 
with BC at any age or 
• 
one first-degree or second-degree relative diagnosed with BC at any age and one first-
degree or second-degree relative diagnosed with ovarian cancer at any age (one of these 
should be a first-degree relative) or 
• 
three first-degree or second-degree relatives diagnosed with BC at any age. 
† first-degree relative = mother/father, sister/brother, daughter/son 
* second degree relative = grandparent, grandchild, aunt/uncle, niece/nephew, half-sister/half-
brother 
 
Potential participants who are unsure of whether they meet the above criteria will be encouraged 
to contact the study team for clarification on whether they are eligible, particularly if any of the 
below are present within their family: 
• 
bilateral BC  
• 
male BC  
• 
ovarian cancer  
• 
Jewish ancestry  
• 
sarcoma in a relative younger than age 45 years  
• 
glioma or childhood adrenal cortical carcinomas  

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• 
complicated patterns of multiple cancers at a young age 
• 
paternal history of BC (two or more relatives on the father's side of the family). 
 
One of the FHRPC clinicians (e.g. Professor Tony Howell, Professor Gareth Evans, Dr Sacha Howell) 
will provide final decision on eligibility where family history does not clearly fit with the NICE referral 
guidelines. 
 
6.5 Verification of risk for women recruited outside of the FHRPC 
Before consent we will only verify family history verbally with the participant during completion of 
the Screening Proforma.  It is recognised that this could result in individual(s) joining the study who 
do not meet the above NICE criteria, for example because of false information given by the 
participant due to deception or misunderstanding17.  The risk this poses to the study is considered 
minimal due to the low possibility of this occurring.  The risk to participants admitted erroneously 
to the study is also considered low as this is not a medical intervention and any distress would be 
dealt with in the same way for all participants by following the Distress Protocol document.  A 
participant found to be not at increased risk of BC after consent to the study will be contacted before 
removal from the study and support will be provided by signposting to relevant agencies, e.g. their 
GP, or free counselling via the NHS. 
 
6.6 Referral to FHRPC for women recruited outside of the FHRPC 
Women identified as being at increased risk of breast cancer will be advised to seek referral to a 
local NHS FHRPC via their GP for full assessment and verification of family history, and the ability to 
access risk reducing treatments / enhanced screening as applicable. This will not a requirement to 
join the study and will not delay their commencement of the study. 
 
6.7 Concerns or queries about services offered by the FHRPC (from both participants and non-
participants) 
For example, questions about eligibility for chemoprevention will be discussed anonymously with 
FHRPC staff and an appropriate response relayed to the individual.  FHRPC patients with queries 
about their treatment, e.g. unsure when their next mammogram is due, will be reminded of the 
contact details for the FHRPC. 
 
6.8 Reimbursement 
There are no payments for taking part in the study. 
 
6.9 Participants who withdraw consent (or lose capacity to consent):  
Participants can withdraw consent at any time without giving any reason, as participation in the 
research is voluntary, without their care or legal rights being affected. Participants can request that 
any data collected on them during their time in the study is destroyed. If it is brought to the attention 
of the research team that a participant has lost capacity to consent during the study, for example 
by the participant's GP, they would be withdrawn from the study.  No further data would be 
collected. Once data has been anonymised it will not be possible to remove it. As only the participant 
can delete their own Facebook data (i.e. posts/comments/reactions/private messages they have 
made within the private Facebook group), their Facebook data will remain in the group for analysis 
(unless they remove it) and they are made aware of this on the PIS.  
 
 

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7) OUTCOME MEASURES 
 
Table 1: Outcome measures and how they will be evaluated 
Process to 
evaluate 
Method of data 
collection 
Aims to explore 
Method of analysis / data to 
be presented 
Timepoint of 
analysis 
Recruitment 
methods 
 
  
Recruitment 
data 
 
 
 
 
Interviews 
Recruitment source of 
the participants 
 
 
 
 
Acceptability of 
recruitment procedure 
Recruitment data, e.g. 
percentage response to 
mailshot, percentage uptake, 
breakdown of numbers 
recruited via each method 
 
Analysis of qualitative 
interviews 
At end of 
recruitment 
phase 
 
 
 
Interviews at 
end of study 
Consent 
method 
Interviews 
Acceptability of 
consent procedure 
Analysis of qualitative 
interviews 
Interviews at 
end of study 
App: 
participant 
views 
 
Interviews, final 
questionnaire, 
app feedback 
questionnaires, 
feedback 
received by e-
mail 
 
Acceptability of the 
app, barriers and 
facilitators to 
engagement, likes and 
don’t likes within app, 
usability, likelihood of 
extended use. 
Analysis of qualitative 
interviews, Analysis of final 
questionnaire and app 
feedback questionnaires: e.g. 
functions most liked, 
suggested changes. 
 
 
Middle, during 
and end of 
study 
App: 
participant 
usage 
App usage data 
Frequency of use, 
pattern of use across 
the two months, 
interaction with 
components within 
app. 
Analysis of app analytics. 
• Number of times visited the 
app 
• Clicks on links within the app 
to external sites  
• Clicks from notifications 
• Clicks on help buttons 
• Flow through the app (which 
screens in which sequence)  
• Duration spent on each page 
/ on the app in total 
End of study 
App: 
completion of 
information 
including logs  
Download of 
completed 
information 
including logs 
Correct completion of 
the settings 
information and 
completion frequency 
of the logs  
Actual vs chosen frequency of 
completion of logs and change 
over time. 
 
Any errors in information 
inputted e.g. kg entered as 
stones and pounds. 
 
Number of logs completed for 
each health behaviour. 
End of study 

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Process to 
evaluate 
Method of data 
collection 
Aims to explore 
Method of analysis / data to 
be presented 
Timepoint of 
analysis 
HCP time 
required 
 
HCP time logs 
HCP time required for 
moderating Facebook 
chat group, and 
through e-mail/private 
message support. 
Breakdown of HCP time spent 
in total and per person on 
moderating Facebook chat 
group, responding to private 
messages and e-mails. 
End of study 
Engagement 
with the 
Facebook 
group 
Download of 
data from the 
group. 
Number of participant 
interactions in the 
Facebook group, 
pattern of interactions 
over the two months. 
Analysis of Facebook 
download (see 9.1.1) 
End of study 
Time needed 
to collect, 
clean and 
analyse data 
Staff time logs 
Estimate of staff time 
and costs for larger 
study 
Breakdown of staff time spend 
on the study, including 
cleaning the app data. 
 
End of study 
 
8) DATA COLLECTION, SOURCE DATA AND CONFIDENTIALITY 
 
Table 2: Data collection methods 
Method of data collection 
Source data 
Confidentiality plan 
Recruitment data 
Screening Proforma 
 
 
E-mails from interested participants 
to secure nhs.net e-mail address 
 
Screening Proformas will be completed 
directly on to the University of 
Manchester secure server. 
E-mails will be kept on the secure server 
until recruitment data is entered for full 
reporting of study recruitment data18, 19.  
E-mails to the NHS.net e-mail address 
are stored on NHS servers. 
Information held on app 
 
Information completed by 
participants on app, e.g. health logs, 
entered onto app by participants  
(see separate document: “App 
screenprints”).  When participants 
enter data into the app it is stored 
on the University of Manchester 
secure ‘Storage Connect’ drive 
Participants do not enter their name 
on to the app. 
 
Data downloaded from University of 
Manchester ‘Storage Connect’ drive 
that comes from app entries. 
Data from completed logs saved on 
‘Storage Connect’ which is a secure 
University of Manchester drive.  Data 
will be held in anonymous form without 
names therefore downloads will also be 
anonymous. 
 
 
 
 
Anonymous data downloads will be 
held on the University of Manchester 
secure server for analysis. 
Questionnaires  
Questionnaires completed by 
participant via Qualtrics, a GDPR-
compliant online survey tool 
approved by University of 
Data will be downloaded from Qualtrics 
in anonymous form and stored on 
secure University of Manchester 
servers. 

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Manchester Information Governance 
Office. 
 
Participants enter their study ID number 
when completing these, instead of their 
name. 
App usage data  
 
Data downloaded from University of 
Manchester ‘Storage Connect’ drive 
that comes from app usage tracking. 
As per “Information held on app” 
above. 
E-mails 
All e-mail correspondence with 
participants will be via the secure 
nhs.net address which is hosted on 
secure NHS servers. 
No e-mails will be printed or forwarded 
from this address. 
E-mails to the NHS.net e-mail address 
are stored on NHS servers. 
Interviews  
(see document: Qualitative 
study plan and interview 
schedule) 
Transcripts of interviews. 
Audio-recordings and transcripts will be 
anonymised and held on secure 
University of Manchester drives.  
Transcription will be done by a 
university-approved transcription 
service who are under a confidentiality 
agreement. Transfer of recordings to 
the transcription service will be in line 
with University of Manchester guidance 
which allows the use of either 
University of Manchester Dropbox 
Service or Zendto. In subsequent write 
up, direct quotes may be used but will 
not be accompanied by names or other 
identifying information. 
Facebook data 
Data, e.g. the text of posts, will be 
copied and pasted from the private 
Facebook group to Excel with 
identifying information removed.  
Study ID numbers will be used 
instead of names.  Number of 
reactions to each post will be 
entered. 
No identifying information will be in the 
Excel document which will be saved on 
the secure University of Manchester 
servers. 
Access to the private Facebook group is 
by invite only to study participants who 
are reminded not to post personal 
information (such as address, family 
details). 
 
Study data and material will be accessible by the study team and may also be looked at by individuals 
from the University of Manchester or from regulatory authorities, for monitoring and auditing 
purposes, and this may include access to personal information. 
 
 
9) STATISTICAL CONSIDERATIONS 
9.1 Statistical Analysis 
This study is to assess the acceptability and usability of the app before a larger feasibility study is 
planned and as such is not powered according to the outcome measures of that larger study. 
 
9.1.1 Quantitative analysis 

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Key baseline demographics and health behaviours will be presented, e.g. smoking status, alcohol 
intake and PA in previous week, age, living circumstances, ethnicity20, education level, employment 
status,  sociodemographic status (deprivation score: English Indices of Multiple Deprivation [EIMD] 
derived from full postcodes21), children, previous attendance at FHRPC, using mean (SD), median 
(25th-75th percentile), n (%) as appropriate.  
 
Data from the private Facebook group will be extracted by copying and pasting into Excel, and 
anonymised.  Data will be comments, posts (or descriptions of posts in the case of photo or video 
posts), numbers of reactions. The use of an application programme interface (API) will not be 
considered for this small study.  Quantitative data will be presented, e.g. number of comments in 
reaction to weekly educational posts (total, average number per post and range, subjects evoking 
the highest number of comments, number of users commenting), number of posts by participants, 
number of likes and reactions (total, average number per post and range, subjects evoking the 
highest number of reactions, number of users reacting), number of private messages to the 
moderators (number of users messaging, total number of messages received and sent)22.  No 
qualitative analysis is planned on the text. 
 
App usage data (number of times visited the app, clicks on links within the app to external sites, 
clicks from notifications, clicks on help buttons, flow through the app (which screens in which 
sequence), duration spent on each page / on the app in total) will also be presented descriptively. 
 
9.1.2 Qualitative analysis 
Transcripts will be analysed using thematic analysis23. Analysis will be inductive: open-ended, 
exploratory, and driven by the data. Thematic analysis is arguably the foundation of all qualitative 
analyses. It is free from theoretical bonds and is therefore adaptable to a wide range of 
methodologies. This freedom of epistemology means that the qualitative data from this study can 
provide a parallel and complimentary perspective to the other methods of data collection being 
used in this study. Thematic analysis can account for both individual and group consensus, so that 
both convergent and divergent experiences across the corpus of the data can be taken into account 
as the process of analysis involves searching for all salient themes that emerge from the data. 
Analysis will be conducted by a trained qualitative researcher (University of Manchester staff).  
Codes will be discussed, revised and refined in conjunction with Professor David French. 
 
9.2 Sample Size 
The study will recruit 35 women, of which up to 20 will be interviewed. A decision on when to stop 
further interviews will be made when no novel insights appear in the interviews according to the 
concept of "information power"24.  The study sample size of 35 will allow for a 20% drop out and 
selection of a range of women to interview, for example both heavy and light engagers with the 
app.  The study is not powered to assess efficacy of the app at changing health behaviours but two 
months usage by 28+ users will enable the quantitative data to give helpful indications of changes 
required before a larger efficacy study. 
 
 
10) DATA MONITORING AND QUALITY ASSURANCE 
The study will be subject to the audit and monitoring regime of the University of Manchester. The 
Study Management Group (Section 1) is responsible for ensuring the appropriate, effective and 
timely implementation of the study including monitoring adherence to protocol. The day-to-day 

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operational management of the study is co-ordinated by Mary Pegington who reports weekly to Dr 
Michelle Harvie.  
 
10.1 Data retention 
The anonymised dataset will be stored on the secure University of Manchester research drive for 
10 years.  Consent forms will be downloaded from Qualtrics and kept on the secure University of 
Manchester research drive for two years after the end of the study as per University of Manchester 
"Records Retention Schedule" (https://documents.manchester.ac.uk/display.aspx?DocID=6514) 
and the file names will contain the participant initials (reflecting the name on the consent form) and 
not the study ID as this link is to be broken.  After data analysis is complete, the fully anonymised 
data will be uploaded on to Figshare as per University of Manchester guidance and will remain there 
indefinitely (Sharing (The University of Manchester Library)). 
 
 
11) SAFETY CONSIDERATIONS AND ADVERSE EVENTS  
This study is considered low risk.  Women in the study have a family history of BC and the study 
team will be sensitive regarding this – see Distress Protocol document.  During the study, data on 
alcohol intake and weight will be downloaded weekly and if app entries indicate either 1) a weight 
increase of 5% from the first weight entered (e.g. an increase from 60 to 63 kg, or 9 st 6 lb to 9 st 13 
lb), or 2) >14 units alcohol per week for three weeks, we will contact the participant by e-mail to 
offer support (by e-mail or phone consultation) and it will be the participant’s choice whether to 
accept that support.  As part of the study, signposting is available for women who wish to stop 
smoking or reduce alcohol intake.  
 
Should any of the interviews take place in person we will follow the University of Manchester policy 
on lone working (Lone working (The University of Manchester)) for example the interviewer will use 
a buddy system to ensure that a designated colleague is aware of their movements.  Mary Pegington 
will be the buddy in the first instance but if she is not available the buddy will be another member 
of the research team. The interviewer will provide the buddy with date, time and address of 
interview and name of interviewee in a password-protected document by e-mail, along with their 
car make, model, colour and registration.  The interviewer will call the buddy before entering the 
property, and upon exiting the property.  In the event of no response, the buddy will call the 
interviewer at 30 minutes after the expected time of departure from the address, and again at 60 
minutes.  If no response at this time they will inform the interviewee’s line manager (David French) 
and the police. Details of all calls and attempted calls will be documented on the password-
protected document.  On completion of the interview and safe departure of the interviewee, the 
password-protected document will be deleted by the interviewer and the buddy.  Appropriate 
procedures will be followed in pandemic conditions, for example mask wearing, space and 
ventilation, and sanitising of surfaces. 
 
The risks to confidentiality are minimal as all data is entered directly on to secure electronic 
platforms and participants are reminded not to enter personal information (such as address, family 
details) on to the private Facebook group. 
 
 
12) PPI INVOLVEMENT 
A PPI participant is a member of the TMG and has been involved with: 
- 
Review of the protocol 

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- 
Review of study paperwork including PIS and invitation letters 
PPI participants will be reimbursed according to NIHR guidance 
(https://www.nihr.ac.uk/documents/payment-guidance-for-researchers-and-
professionals/27392). 
 
 
13) 
POTENTIAL LIMITATIONS 
The study is only two months long therefore we will be unable to assess app usage over a longer 
timeframe. However this study is not aiming to achieve that, and the questionnaires and interviews 
will inform whether longer term use is likely, and changes that are required to improve engagement 
and longevity that will be employed in the subsequent feasibility study. 
 
 
14) 
PLANNED FUTURE STEPS 
As per “Developing and evaluating complex interventions: the new Medical Research Council 
guidance”15, this study forms part of assessing feasibility before the evaluation phase and after this 
study we plan to continue following this guidance. 
 
Further development and testing 
If this study shows that the app is acceptable to the target audience, it will be used in a future 
planned feasibility study. The feasibility study will in turn inform the feasibility of a larger, definitive 
multicentre, randomised controlled trial to test the effectiveness and cost-effectiveness of the app 
amongst young women at increased risk of BC. 
 
Implementation 
Should the intervention be effective it could be implemented amongst the following groups: 
• 
Introduction to all FHRPCs in the UK  
• 
Widen scope to women at increased risk of BC not only by means of family history, e.g. Dr 
Sacha Howell’s project in Manchester plans identify more women at increased risk due to 
breast density and single-nucleotide polymorphisms (https://research.cmft.nhs.uk/news-
events/new-study-addresses-early-breast-cancer-detection-in-high-risk-young-women)  
• 
Widen scope to include women at increased risk above age 35 
• 
Other high risk cancer groups, i.e. lynch syndrome 
 
 
15) PANDEMIC CONTINGENCY PLAN 
This study includes optional face-to-face interviews with all other aspects of the study being 
remotely-delivered.   Therefore this study will be able to continue in the event of a pandemic and 
the option of face-to-face interviews will be withdrawn if these are no longer considered safe or not 
allowed under current restrictions.  Interviews will instead take place via Microsoft Teams or phone. 
 
 
16) PEER REVIEW 
This protocol has been reviewed by all Co-Investigators.  The Co-Investigators have a wide base of 
clinical and research expertise: behavioural psychology (Prof David French, Dr Julia Mueller), health 
data science (Dr Alan Davies), research dietetics (Mary Pegington*, Dr Michelle Harvie*), oncology 
(Prof Tony Howell*, Dr Sacha Howell*) and genetics (Prof Gareth Evans*). Five of the team are 

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affiliated with the FHRPC at Wythenshawe Hospital (*).  We also have a PPI representative from our 
FHRPC as one of our co-investigators. The team have published over 1,000 peer-reviewed articles 
between them. 
 
 
17) 
ETHICAL AND REGULATORY CONSIDERATIONS  
NHS Research Ethics Committee and HRA approval will be obtained before commencing research. 
 
The study will be conducted in full conformance with all relevant legal requirements and the 
principles of the Declaration of Helsinki, Good Clinical Practice (GCP) and the UK Policy Framework 
for Health and Social Care Research 2017. 
 
 
18)    STATEMENT OF INDEMNITY  
The University has insurance available in respect of research involving human subjects that provides 
cover for legal liabilities arising from its actions or those of its staff or supervised students.  The 
University also has insurance available that provides compensation for non-negligent harm to 
research subjects occasioned in circumstances that are under the control of the University. 
 
 
19)    FUNDING and RESOURCES 
MP (CI) is funded for this study by National Institute for Health Research (NIHR) Manchester 
Biomedical Research Centre (BRC).  Study costs are funded by NIHR Manchester BRC, for example: 
• 
Admin time at MFT for identifying participants, posting invitation letters, tracking 
questionnaire completion. 
• 
A trained qualitative researcher from The University of Manchester will design and perform 
the interviews, analysis, and write up. 
• 
Research Software Engineer support at University of Manchester. 
 
 
20)    PUBLICATION POLICY  
Following completion of the study, data will be analysed and results published in a peer-reviewed 
journal.  If participants have given consent to be contacted with a summary of the results they will 
receive this after publication.  
 
 
21)    REFERENCES 
1. 
Cancer Research UK. Cancer mortality statistics 
https://www.cancerresearchuk.org/health-professional/cancer-statistics/mortality2021 
[08/03/21]. Available from: https://www.cancerresearchuk.org/health-professional/cancer-
statistics/mortality. 
2. 
Maddams J, Utley M, Moller H. Projections of cancer prevalence in the United Kingdom, 
2010-2040. Br J Cancer. 2012;107(7):1195-202. 
3. 
Brown KF, Rumgay H, Dunlop C, Ryan M, Quartly F, Cox A, et al. The fraction of cancer 
attributable to modifiable risk factors in England, Wales, Scotland, Northern Ireland, and the 
United Kingdom in 2015. Br J Cancer. 2018;118(8):1130-41. 

Version 3.0 26/04/2022 
IRAS ID: 307594 
 
 
Research Protocol: Acceptance and usability of the healthy behaviours app                                                          Page 22 of 23 
4. 
World Cancer Research Fund, American Institute for Cancer Research. Continuous Update 
Project Expert Report. Diet, nutrition, physical activity and breast cancer. 2018. 
5. 
Brentnall AR, van Veen EM, Harkness EF, Rafiq S, Byers H, Astley SM, et al. A case-control 
evaluation of 143 single nucleotide polymorphisms for breast cancer risk stratification with 
classical factors and mammographic density. Int J Cancer. 2020;146(8):2122-9. 
6. 
Kehm RD, Genkinger JM, MacInnis RJ, John EM, Phillips KA, Dite GS, et al. Recreational 
Physical Activity Is Associated with Reduced Breast Cancer Risk in Adult Women at High Risk for 
Breast Cancer: A Cohort Study of Women Selected for Familial and Genetic Risk. Cancer Res. 
2020;80(1):116-25. 
7. 
Gramling R, Lash TL, Rothman KJ, Cabral HJ, Silliman R, Roberts M, et al. Family history of 
later-onset breast cancer, breast healthy behavior and invasive breast cancer among 
postmenopausal women: a cohort study. Breast Cancer Research. 2010;12(5):R82. 
8. 
Jones ME, Schoemaker MJ, Wright LB, Ashworth A, Swerdlow AJ. Smoking and risk of 
breast cancer in the Generations Study cohort. Breast Cancer Res. 2017;19(1):118. 
9. 
Hopper JL, Dite GS, MacInnis RJ, Liao Y, Zeinomar N, Knight JA, et al. Age-specific breast 
cancer risk by body mass index and familial risk: prospective family study cohort (ProF-SC). Breast 
Cancer Res. 2018;20(1):132. 
10. 
NICE. Clinical guideline CG164. Familial breast cancer classification, care and managing 
breast cancer and related risks in people with a family history of breast cancer. 2013. 
11. 
Pegington M, Evans DG, Howell A, Donnelly LS, Wiseman J, Cuzick JM, et al. Lifestyle 
behaviours and health measures of women at increased risk of breast cancer taking 
chemoprevention. Eur J Cancer Prev. 2019;28(6):500-6. 
12. 
Pegington M, French DP, Harvie MN. Why young women gain weight: A narrative review of 
influencing factors and possible solutions. Obes Rev. 2020;21(5):e13002. 
13. 
Hewitt RM, Pegington M, Harvie M, French DP. How acceptable is a weight maintenance 
programme for healthy weight young women who are at increased risk of breast cancer? Psychol 
Health. 2020;35(7):854-71. 
14. 
National Institute of Health and Care Excellence. Evidence Standards Framework for Digital 
Health Technologies. 2018. 
15. 
Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and 
evaluating complex interventions: the new Medical Research Council guidance. BMJ. 
2008;337:a1655. 
16. 
Kennedy M, Kumar R, Ryan NM, Bennett J, La Hera Fuentes G, Gould GS. Codeveloping a 
multibehavioural mobile phone app to enhance social and emotional well-being and reduce health 
risks among Aboriginal and Torres Strait Islander women during preconception and pregnancy: a 
three-phased mixed-methods study. BMJ Open. 2021;11(11):e052545. 
17. 
Kerr B, Foulkes WD, Cade D, Hadfield L, Hopwood P, Serruya C, et al. False family history of 
breast cancer in the family cancer clinic. European Journal of Surgical Oncology (EJSO). 
1998;24(4):275-9. 
18. 
Buus N, Perron A. The quality of quality criteria: Replicating the development of the 
Consolidated Criteria for Reporting Qualitative Research (COREQ). International Journal of Nursing 
Studies. 2020;102:103452. 
19. 
Lancaster GA, Thabane L. Guidelines for reporting non-randomised pilot and feasibility 
studies. Pilot and Feasibility Studies. 2019;5(1). 
20. 
Race Disparity Unit CO. List of ethnic groups  [Available from: https://www.ethnicity-facts-
figures.service.gov.uk/style-guide/ethnic-groups. 

Version 3.0 26/04/2022 
IRAS ID: 307594 
 
 
Research Protocol: Acceptance and usability of the healthy behaviours app                                                          Page 23 of 23 
21. 
Office for National Statistics. Postcode Directories: UK Data Service Census Support. 
2021(08/03/21). 
22. 
Franz D, Marsh HE, Chen JI, Teo AR. Using Facebook for Qualitative Research: A Brief 
Primer. Journal of Medical Internet Research. 2019;21(8):e13544. 
23. 
Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in 
Psychology. 2006;3(2):77-101. 
24. 
Malterud K, Siersma VD, Guassora AD. Sample Size in Qualitative Interview Studies. 
Qualitative Health Research. 2016;26(13):1753-60.