Shared Decision-making: Investigating the Potential of an Interactive, Web-Based, Information Tool for People With Advanced Pancreatic Cancer
Conditions: Advanced Pancreatic Cancer
Sponsor: Bournemouth University

 
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Shared Decision-Making: Investigating the Potential of an Interactive, Web-
Based Information Tool to Support Treatment Choice of People with Advanced 
Pancreatic Cancer 
 
(Web-Based Tool to Support Treatment Choice in Advanced Cancer) 
 
Protocol Version and date 
Version 1, 22 June 2018 
ISRCTN No.:  
Not applicable  
Research Ethics Number 
 
NIHR Portfolio Number 
N/A 
Funder:  
Bournemouth University and  
Poole Hospital NHS Foundation Trust 
Sponsor:  
Bournemouth University 
Sponsor Reference Number: 
 
 
Protocol authorised by: 
 
Name & Role 
Date 
Signature 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Contact details 
 
Chief Investigator:   Dr Janet Scammell 
 
 
 
Associate Professor 
Department of Nursing and Clinical Sciences,  
Faculty of Health and Social Sciences 
 
 
 
Bournemouth University  
 
 
 
Bournemouth House 
 
 
 
17-19 Christchurch Road 
 
 
 
Bournemouth, BH1 3LH 
Telephone Number: 
01202 962751 
Email address: 
jscammell@bournemouth.ac.uk 
 
Researcher:  
Ejike T. Ezeh 
 
 
 
Postgraduate Researcher 
 
 
 
Bournemouth University  
 
 
 
Bournemouth House 
 
 
 
17-19 Christchurch Road 
 
 
 
Bournemouth, BH1 3LH 
 
Telephone Number: 
01202961733 
Email address:  
eezeh@bournemouth.ac.uk 
 

 
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Supervisors:  
Dr Janet Scammell 
Associate Professor 
Department of Nursing and Clinical Sciences,  
Faculty of Health and Social Sciences 
 
 
 
Bournemouth University  
 
 
 
Bournemouth House 
 
 
 
17-19 Christchurch Road 
 
 
 
Bournemouth, BH1 3LH 
Telephone Number: 
01202 962751 
Email address: 
jscammell@bournemouth.ac.uk 
 
 
 
 
Professor Tamas Hickish 
 
 
 
 
Consultant Medical Oncologist &  
Visiting Professor to Bournemouth University 
Bournemouth University 
Royal London House 
Bournemouth, BH1 3LT 
Telephone Number: 
01202 962183 
Email address: 
thickish@bournemouth.ac.uk 
 
Dr Nan Jiang 
Principal Academic in Software Quality & 
Software Testing 
Poole House P429,  
Talbot Campus, Fern Barrow, Poole, BH12 5BB 
Telephone number: 
01202 962741 
Email address: 
njiang@bournemouth.ac.uk 
 
 
 
 
 
Professor Sam Porter 
Professor and Head of Department 
Social Work & Social Sciences 
Bournemouth University  
Royal London House 
Bournemouth, BH1 3LT 
Telephone number: 
01202 964107 
Email address: 
porters@bournemouth.ac.uk 
 
 
Study Coordinating Centre 
Bournemouth University (BU) 
 
Study Coordinator:  Suzanne Wignall 
Telephone Number:  01202 961073 
Email address: 
swignall@bournemouth.ac.uk 
 
 
 
 
 
 
Sponsor 
Bournemouth University  
 
 
Funder 
Bournemouth University 
Poole Hospital NHS Foundation Trust 

 
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Table of Contents 
1 
INTRODUCTION 
8 
1.1 
BACKGROUND 
8 
1.2 
RESEARCH RATIONALE 
9 
1.2.1 The need for an evidence-based information tool for APC treatment options 
9 
1.2.2 The support for the policy priority for patient-centred care in the UK 
9 
1.2.3 Enhancing clinicians’ communicative skills 
9 
1.2.4 Improving medical cost-effectiveness 
9 
2 
OBJECTIVES 
9 
2.1 
PRIMARY OBJECTIVE 
9 
2.2 
SECOND OBJECTIVES 
9 
3 
STUDY DESIGN 
10 
3.1 
RESEARCH METHODS 
10 
3.1.1 Phase 1: Systematic review and network meta-analysis 
10 
3.1.2 Phase 2a: Focus groups/interviews with clinicians 
11 
3.1.3 Phase 2b: Interviews with patients and relatives 
11 
3.1.4 Phase 3: Information tool development 
11 
3.1.5 Phase 4: Evaluation of developed information tool 
12 
3.2 
STUDY PRIMARY AND SECONDARY OUTCOME MEASURES 
13 
3.3 
DEFINITION OF END OF STUDY 
13 
3.4 
DATA COLLECTION 
13 
3.5 
SOURCE DATA 
13 
4 
PARTICIPANT SELECTION 
13 
4.1 
DEFINITION OF PARTICIPANT GROUPS 
13 
4.2 
RECRUITMENT 
14 
4.2.1 NHS recruitment 
14 
4.2.2 PCUK recruitment 
14 
4.2.3 Recruitment style 
14 
4.2.4 Stages of recruitment 
15 
4.3 
PRE-REGISTRATION OR RANDOMISATION EVALUATIONS 
16 
4.4 
INCLUSION CRITERIA AND EXCLUSION CRITERIA 
16 
4.5 
WITHDRAWAL CRITERIA 
17 
5 
TREATMENT OR THERAPY PLAN 
17 
5.1 
DESCRIPTION OF TREATMENT OR THERAPY 
17 
5.2 
TREATMENT ARMS 
17 
6 
ASSESSMENT AND FOLLOW-UP 
17 
6.1 
DURATION OF TREATMENT OR THERAPY 
17 
6.2 
DURATION OF FOLLOW-UP 
17 
6.3 
SUBJECT COMPLIANCE OR CRITERIA FOR REMOVAL FROM STUDY 
17 
7 
ASSESSMENT OF SAFETY 
17 
7.1 
DEFINITION 
17 
7.2 
RISKS 
18 
7.3 
BURDENS 
18 

 
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7.4 
REPORTING PROCEDURES FOR ADVERSE EVENTS 
18 
8 
STATISTICS AND DATA ANALYSIS 
18 
8.1 
DESCRIPTION OF STATISTICAL METHODS 
18 
8.2 
NUMBER OF PARTICIPANTS 
19 
8.3 
CRITERIA FOR TERMINATION OF THE STUDY 
20 
9 
ETHICAL, REGULATORY, ADMINISTRATIVE AND QUALITY 
ASSURANCE 
20 
9.1 
ETHICAL CONSIDERATIONS 
20 
9.2 
DECLARATION OF HELSINKI 
20 
9.3 
RESEARCH GOVERNANCE 
20 
9.4 
CONSENT PROCESS 
20 
9.5 
PARTICIPANT CONFIDENTIALITY 
20 
9.6 
STUDY MANAGEMENT 
21 
9.7 
MONITORING 
21 
9.8 
AUDIT AND INSPECTION 
21 
10 
DATA HANDLING AND RECORD KEEPING 
21 
10.1 ARCHIVING 
21 
11 
FINANCE, INDEMNITY AND INSURANCE 
21 
11.1 FUNDING 
21 
11.2 SPONSOR 
21 
11.3 INDEMNITY 
22 
12 
PUBLICATION POLICY AND INTELLECTUAL PROPERTY 
22 
 

 
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Amendment History 
 
Amendment 
No. 
Protocol 
Version 
No. 
Date 
issued 
Author(s) 
of 
changes 
Details 
of 
Changes 
made 
 
 
 
 
 
 
 
 
 
 
 
Study synopsis 
  
Study title 
Shared decision-making: investigating the potential of an 
interactive, web-based information tool to support treatment 
choice of people with advanced pancreatic cancer 
Sponsor 
Reference No. 
 
Study design 
Multiphase mixed methods design 
Study participants 
Oncologists,  
clinical nurse specialists,  
people diagnosed with advanced pancreatic cancer, and 
their  
relatives who provide care and support for them 
Sample size 
120 
Follow-up duration 
Not applicable 
Planned study 
period 
August 2018 – December 2019 
Primary objectives 
To investigate the potential of a web-based, interactive, 
information tool in facilitating shared decision-making for 
the choice of treatment for people with advanced 
pancreatic cancer (APC) 
 
Secondary 
objectives 
(i) 
To assess the quality of life, efficacy, and safety of 
chemotherapy treatments of APC through systematic 
review and network meta-analysis (NMA) of randomized 
controlled trials (RCTs). 
 
(ii) 
To explore the expectations and preferences of 
clinicians, people with APC, and their relatives, when 
making decisions about treatment, through focus groups 
and semi-structured interviews for clinicians, and people 
with APC (including their relatives), respectively. 
 
(iii) 
To identify the features necessary for the design of a 
web-based information tool to facilitate SDM between 
clinicians and people with APC about choice of treatment. 
 
(iv) 
To evaluate the effectiveness of the developed 
information tool in SDM, through a pilot test with clinicians 
(doctors and nurse specialists), people with APC, and 
their relatives. 

 
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Primary endpoint 
Effectiveness of Shared decision-making 
Interventions  
Not applicable 
  

 
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Abbreviations 
 
AE 
Adverse Event 
BSC 
Best Supportive Care 
BU 
Bournemouth University 
BUCRU PPI 
 Bournemouth University Clinical Research Unit Patient and Public 
Involvement 
CI 
Chief Investigator 
DCS 
Decisional Conflict Scale 
EU 
European Union 
HRQoL 
Health Related Quality of Life 
MRC 
Medical Research Council 
NHS 
National Health Service 
NMA 
Network Meta-analysis 
PC 
Pancreatic Cancer 
PCUK 
Pancreatic Cancer United Kingdom 
PIS 
Participant Information Sheet 
R&KEO 
Research & Knowledge Exchange Office 
RCT 
Randomised Controlled Trial 
REC 
Research Ethics Committee 
SDM 
Shared Decision Making 
SUCRA 
Surface Under the Cumulative Rank Area 
SUS 
System Usability Scale 
 
Key Words 
Pancreatic cancer, web-based information tool, patient decision aid, mixed methods, 
systematic review, network meta-analysis, interviews, focus group 
 

 
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1 
Introduction 
1.1 
Background  
Pancreatic cancer (PC) is a disease with very low 5-year survival rates. Some 
estimates set this at less than 5% (Vincent et al. 2011; Balaban et al. 2016). In the 
European Union (EU), over 85,000 deaths were projected in 2017, which is a rise of 
around 8.0% from 2012 (Malvezzi et al. 2017). PC can be broadly classified as 
locally resectable, borderline resectable, locally advanced, and metastatic (Vincent et 
al. 2011). Treatments include surgery, chemotherapy, radiation therapy, and 
palliative care (Kamisawa et al. 2016). Surgery offers curative treatment, but 80% of 
patients are diagnosed in the advanced stage (locally advanced or metastatic) and 
are ineligible (Ducreux et al. 2015; Taieb et al. 2017). However, systemic therapy 
(such as chemotherapy) is a palliative option for people with advanced pancreatic 
cancer (APC) (Balaban et al. 2016). “Best supportive care” (BSC), or “supportive 
care”, is another option which involves symptom management and improving quality 
of life (Hui et al. 2013).  
Shared decision-making (SDM) is a process where clinicians and patients make 
decisions together using the best available evidence (Elwyn et al. 2010). SDM is 
recognised as a policy priority and ethical imperative by the National Health Service 
(NHS) and several healthcare regulators in the United Kingdom (UK), respectively 
(Coulter et al. 2017). The concept of equipoise is a scenario where there is more 
than one legitimate choice of treatment for a medical condition (Edwards et al. 2000; 
Elwyn et al. 2000). It offers an opportunity to apply SDM in discussing the choice of 
treatment for people with APC because there is no clear preference of treatment 
options in terms of benefits and risks for APC (Balaban et al. 2016). Moreover, a 
systematic review by Gravel et al. (2006) indicated, among other things, that SDM 
facilitated positive impact on the clinical process and patient outcomes. Encouraging 
SDM in APC treatment could yield similar results, including the reduction in selecting 
aggressive treatments that have little or no corresponding economic or personal 
benefits (Oshima Lee and Emanuel 2013; Veroff et al. 2013). 
Several tools have been developed to enhance SDM in relation to other medical 
conditions (Agoritsas et al. 2015; Elwyn et al. 2016). Some of these tools are for 
ovarian cancer (Vogel et al. 2013), stage IV lung cancer (Leighl et al. 2008), and 
colorectal cancer (Leighl et al. 2011). CONNECT ™ is a computer-based tool that 
was developed for the general improvement of the doctor-patient communication 
process (Meropol et al. 2013). Additionally, a systematic review conducted by Austin 
et al. (2015) showed that decision tools can improve patients’ knowledge and 
awareness of the treatment options available to them.  However, there is very little in 
literature about the use of evidence-based digital tools in discussing the expected 
outcomes of treatment for people with APC. Although predictive tools have been 
developed for PC (Ansari et al. 2013; Smith and Mezhir 2014; Walczak and 
Velanovich 2017), there is currently no web-based information tool that can provide 
clinical evidence on the treatment choices available to people with APC.  
However, there is an online decision aid developed for patients with APC in Canada 
(Gresham 2013). It has some useful features which can help its users make 
decisions about their treatment, including information about APC. However, its 
automation in comparing treatment options is basic, its depth of information 
necessary for decision-making, and its flexibility could be improved. Its target 
audience are the patients only. It also assumes that users typically have only 3 
options to choose from. 
It is necessary that patients are fully aware of the benefits and risks associated with 
any treatment that is being proposed to them. Also, to ensure that clinicians provide 
the best available evidence-based information in an easily understandable format for 
the patients, the purpose of this study is to develop an interactive, web-based 

 
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information tool to assist in the process of shared decision-making between 
clinicians, and patients and their relatives (or caregivers).  
 
1.2 
Research rationale 
1.2.1 The need for an evidence-based information tool for APC treatment options  
There is currently no web-based, SDM tool for APC that presents information on 
available treatment options in a visual, and concise way to patients so that they and 
their clinicians can make informed choices. Acceptability and reliability are two 
important factors to be considered when developing such tools (Coulter et al. 2017). 
1.2.2 The support for the policy priority for patient-centred care in the UK  
In the United Kingdom, shared decision-making is viewed as a priority in patient care 
(Coulter et al. 2017). However, effective SDM is enhanced through well-informed 
participants, and that is an objective of the proposed information tool.  
1.2.3 Enhancing clinicians’ communicative skills  
Geessink et al. (2017) identified communicative skills in healthcare professionals as 
a requisite for successful SDM. The proposed information tool is hoped to enhance 
clinicians’ capacity to communicate available treatment options with their patients by 
presenting pertinent facts in a concise and user-friendly manner for them.  
1.2.4 Improving medical cost-effectiveness  
This tool could also potentially challenge the “more-is-better” attitude (assumption 
that expensive treatment equals better healthcare) held by the public (Levinson et al. 
2015). Evaluation of some patient decision aids showed improved cost-effectiveness 
in some medical conditions (O'Connor et al. 2004). Introducing the information tool to 
APC treatment could potentially yield similar results. 
 
2 
Objectives 
2.1 
Primary objective 
To investigate the potential of a web-based, interactive, information tool in facilitating 
shared decision-making in the choice of treatment for people with advanced 
pancreatic cancer 
 
2.2 
Second objectives 
(i) To assess the quality of life, efficacy, and safety of chemotherapy 
treatments of APC through systematic review and network meta-analysis 
(NMA) of randomized controlled trials (RCTs). 
 
(ii) To explore the expectations and preferences of clinicians, people with 
APC, and their relatives, when making decisions about treatment, through 
focus groups and semi-structured interviews for clinicians, and people with 
APC (including their relatives), respectively. 
 
(iii) To identify the features necessary for the design of a web-based 
information tool to facilitate SDM between clinicians and people with APC 
about choice of treatment. 
 
(iv) To evaluate the effectiveness of the developed information tool in SDM, 
through a pilot test with clinicians (doctors and nurse specialists), people 
with APC, and their relatives. 

 
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3 
Study design 
A multiphase mixed methods research design has been adopted for this study. It 
involves a series of either sequential or  concurrent discrete phases (Creswell 2010, 
p.100). This design was chosen because of the nature of the research questions that 
are both qualitative and quantitative, and because multiphase mixed methods is 
suitable for evaluation of intervention programs (Creswell 2014). This project involves 
evaluation of an information tool. 
Error! Reference source not found. is an overview of the research design. Phases 
1 and 2 will occur concurrently and will generate information required for the tool 
development in phase 3. Finally, Phase 4 will test the developed tool. The next 
section (Research methods) describes these phases in detail. 
 
 
 
 
 
 
 
 
 
 
Figure 1: 
Study Design Diagram 
 
3.1 
Research methods 
3.1.1 Phase 1: Systematic review and network meta-analysis  
A systematic review and network meta-analysis (SR & NMA) of clinical trials in APC 
treatment shall be performed. The aim is to assess the comparative efficacy and 
safety of the different chemotherapy treatments for APC from reported randomised 
controlled trials. This will provide a basis for the design of the information tool. 
Network meta-analysis is chosen because it has the capacity to make comparison 
between treatments in different studies when they have a common-comparator 
treatment (Jones et al. 2011; Catala-Lopez et al. 2014). Traditional meta-analysis 
summarizes treatment effects for similar studies that compare the same kind of 
regimens, however network meta-analysis is designed to summarize and compare 
effects of different studies. For example, if study 1 compares treatment A vs. B, and 
study 2 compares treatment B vs. C, there is a common comparator, treatment B, 
between studies 1 and 2. Using network meta-analysis, it is statistically possible to 
compare the effects of treatment C vs. A,  even if they were never compared in an 
actual study (Zoccai 2014, p.27), provided that these studies exhibit the transitivity 
assumption, that is, they are similar in all respects (Salanti et al. 2014).  The outcome 
of this network meta-analysis shall be a probability ranking of different available 
treatment options based on a chosen endpoint (study outcome), and surface under 
the cumulative area (SUCRA) statistic (Salanti et al. 2011). The endpoints chosen for 
this network meta-analysis are: overall survival, progression-free survival, disease 
Focus groups and 
semi-structured 
interviews 
(Phase 2) 
Information tool 
development 
(Phase 3) 
Pilot test of 
information tool 
(Phase 4) 
 Systematic Review 
and Network Meta-
analysis 
(Phase 1) 

 
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control rate, toxicity (neutropenia, leukopenia, thrombocytopenia, nausea, fatigue), 
and health-related quality of life (HRQoL). 
The eligibility criteria of included studies for the SR & NMA are: 
 
i. 
First-line chemotherapy treatment. These are treatments used as the primary 
or initial treatment 
ii. 
Phase III randomised controlled trials. These are trials designed for actual 
participants from the target population to determine drug effect 
iii. 
Locally advanced or metastatic PC 
iv. 
Full-text articles 
v. 
English version of reported trials 
vi. 
Studies considering Best Supportive Care (BSC) will be included. These kinds 
of studies typically compare a regimen against symptom management. 
vii. 
Studies published from 1997 onwards; this criteria was chosen because of a 
landmark  study (Burris et al. 1997) that established a chemotherapy 
treatment standard for APC. 
 
Databases to be searched include PubMed, MEDLINE, EMBASE, CENTRAL, Web 
of Science, and Scopus. Manual search of article references will also be done. 
3.1.2 Phase 2a: Focus groups/interviews with clinicians 
Focus groups (or semi-structured interviews) will be conducted for clinicians (doctors 
and clinical nurse specialists) involved in cancer treatment. The focus groups (or 
personal interviews if more convenient for the participants) will be done to explore the 
experiences of the participants in discussing treatment options with patients before 
commencement of treatment. The potential use of an information tool for SDM will be 
explored during the discussions. It is anticipated that an observer who is a member of 
the supervisory team (or somebody nominated by them) will assist the postgraduate 
researcher during the conduct of the focus groups. 
The venue for the focus groups (or semi-structured interviews) will be at the 
hospitals. The maximum duration is 1 hour. 
3.1.3 Phase 2b: Interviews with patients and relatives 
Patients and their relatives shall be interviewed separately to elicit their experiences 
about the consultations they had with clinicians, their mode of information access 
regarding pancreatic cancer, and what they felt could have helped them in making 
choices. Preferences about quality-of-life issues, information needs, and attitudes 
about the use of a web-based tool shall be explored.  
The venue for each interview will be at the hospital, or by phone, or via Skype (or any 
appropriate teleconferencing application). For patients and relatives, there is an 
option of conducting the interview at the residence of the participants (or other 
convenient locations).  
All focus groups and interviews will be audio-recorded (with permission of 
participants) for transcription purposes. 
3.1.4 Phase 3: Information tool development 
A web-based information tool shall be designed using an appropriate technology. 
Shiny package for R1, or Java Enterprise Edition 2 are being considered for this 
phase. A human-centred approach (Giacomin 2014) will be adopted in reasoning 
about the information tool development. It involves communicating with the intended 
users and understanding their needs, experiences and incorporating feedback into 
the development process. 
                                               
1 https://shiny.rstudio.com/ 
2 http://www.oracle.com/technetwork/java/javaee/overview/index.html 

 
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The information tool shall incorporate data from the SR & NMA, and from the 
qualitative data analysis from phase 2. Its essential functionalities will include the 
ability to display the available treatment options to users based on selected 
outcomes, while comparing the benefits and risks of each option. 
The web-based tool will be hosted on BU web development server. 
3.1.5 Phase 4: Evaluation of developed information tool 
The resulting web-based information tool will be tested for its functionality, usability, 
and effectiveness in SDM. Target users are clinicians, patients and relatives of 
patients. Users will be asked to perform certain tasks with the developed tool. These 
tasks will be based on the expected functionalities of the proposed information tool. 
Phase 2 will elicit some of the requirements and functionalities of the proposed 
information tool.  
Phase 4 is designed to be accomplished in two stages: 
Stage 1 will assess the information tool’s usability. It will be for participants who were 
involved in the study during the focus group or semi-structured interviews (phase 2). 
Participants will be asked to complete predefined tasks using the information tool. 
Participants will then provide feedback to inform the tool modification. There will be 
options to accomplish the tasks from the residence of participants through web links 
to the information tool and an online feedback form. Feedback is in the form of a 
questionnaire and open-ended questions.  
Data from stage 1 is primarily for refining the information tool’s functionality and 
usability in preparation for stage 2. 
The average duration for stage 1 test is 30 minutes.  
Stage 2 will evaluate the effectiveness of the proposed information tool in the SDM 
process. It is targeted at real-life consultations between clinicians and patients who 
are starting consultations about their treatment. These patients and relatives will be 
recruited for this stage. Evaluation at this stage involves the effectiveness of the 
decision-making process and decision quality (Sepucha et al. 2013) of the 
information tool.  
Effectiveness of the decision-making process is the extent to which the information 
tool helps the participants in the SDM process. However, decision quality or quality of 
choice measures the extent to which patients are fully informed and receive the 
treatments consistent with their preferences (Sepucha et al. 2013). 
A variety of instruments have been proposed for measuring the effectiveness of SDM 
process (Scholl et al. 2011) and the effectiveness of decision aids (Sepucha et al. 
2013). The Decision Conflict Scale (DCS) (O'Connor 1995) will be adopted for this 
purpose because it has been validated in many studies, it has more than one version 
to suit different participants (Légaré et al. 2012), and it is freely available. 
After each consultation involving SDM with the information tool, all participating 
parties (clinician, patient, relative) will fill out the appropriate DCS form. The form is to 
be completed and returned within 4 weeks after consultation. This is to enable the 
participants to give a reliable evaluation of their experience during the consultation. 
The instruments can be returned at the hospital, by email, or post (stamped 
addressed envelopes will be provided). 
Electronic versions of the DCS will be developed and interested participants can 
choose to provide feedback through this option. 
The duration for filling the DCS form is approximately 10 minutes.  
To assess the decision quality associated with the information tool, Sepucha et al. 
(2013) noted that more than half of the tools reported in the literature were original 
products designed to meet the requirements of each study. Consequently, the 
development of a customised instrument to assess the quality of the decision 
associated with the proposed information tool may be explored. As in the case of 
breast cancer decision quality measurement (Sepucha et al. 2007; Lee et al. 2010), 
the major contents of the decision quality instrument for APC treatment will be 

 
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disease-specific knowledge and value items or goals of the treatment for people with 
APC. 
The content of the proposed instrument will require about 10 minutes to complete. 
 
3.2 
Study Primary and secondary outcome measures 
The second phase of the study is a qualitative study that includes interviews and 
focus groups. Factors that influence the decision-making process during choice of 
PC treatment, and information needs of these groups of people will be explored.  
For the test/evaluation phase of the study, the primary outcome measures are the 
decisional conflict and system usability score. These will be measured with the DCS 
and (adaptions of) the System Usability Scale (SUS) (Brooke 1996), respectively. 
 
3.3 
Definition of end of study 
There are two recruitment stages for this research study. For the first stage, end of 
study is when the participants have completed and returned the usability evaluation 
forms for the web-based information tool. 
For the second stage, end of study is when participants have successfully completed 
and returned the SDM evaluation forms. 
 
3.4 
Data collection 
Data will be extracted from relevant literature for phase 1 of this research with the 
use of excel sheets specially designed for this purpose. This will enable synthesis of 
information regarding the comparative benefits, harms and uncertainties surrounding 
treatment options for APC. 
Data collection for participants will be through recordings during interviews, and focus 
groups, and through completion of survey (paper-based or online). The interview and 
focus groups recordings will be used to identify themes that will broaden the 
knowledge on information needs, expectations and challenges of treatment choices 
for people with APC. 
Web analytic tools like Google Analytics 3 will be included in the information tool to 
collect data on User Behaviour Flow. 
The researcher will be responsible for data collection, transcription and analysis. 
 
3.5 
Source data 
Data sources are from the relevant literature (phase 1), and from participants 
responses during interviews, focus groups (phase2), and completed forms from 
phase 3 and phase 4. For monitoring and audit purposes, the recordings will kept for 
the duration of the permitted duration allowed by data protection act to facilitate 
comparison with corresponding transcriptions of interviews and focus groups. 
 
4 
Participant selection 
Participants shall be clinicians, patients with APC, and their relatives. They are 
defined in section 4.1. 
 
4.1 
Definition of participant groups 
Clinician: a trained medical professional who has had experience in discussing 
outcomes or treatment choices with patients about PC. A clinician can either be an 
oncologist or a clinical nurse specialist. 
Patient: an adult who has been diagnosed with APC and who has discussed 
treatment choices or prognostic outcomes with a clinician. 
                                               
3 https://www.google.com/analytics/analytics/#?modal_active=none 

 
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Relative: an adult who is involved in providing support for the patient during the 
period of treatment. They will normally be nominated by the patient. 
 
4.2 
Recruitment 
Potential clinicians and patients will be recruited from NHS Trust sites in England, 
and through a charity, Pancreatic Cancer UK (PCUK). PCUK have been approached 
regarding their support for the research. 
4.2.1 NHS recruitment 
A member of the site’s clinical care team will identify potential participants for the 
study either through medical records or during hospital appointments, and seek their 
permission to be contacted by the recruiter (researcher or onsite research nurse) 
regarding the research. This initial identification will include collection of the 
Participant Information Sheet (PIS) by the potential participants. There will be a 
minimum of 24 hours to expect a reply to the invitation. 
The recruiter will contact interested persons (either during subsequent appointments, 
or by phone, or email, or through other agreed communication channels) and explain 
the study in more detail. If there are questions, these will be answered by the 
recruiter. 
The potential participant will then be invited to sign the informed consent form to 
indicate acceptance of inclusion in the study. 
For focus groups or face-to-face semi-structured interviews, the informed consent 
form can be signed the same day as the interview (prior to data collection). For 
interviews by phone or Skype (or other teleconferencing software), informed consent 
forms will be signed and returned by post, or email. 
Relatives of patients will be invited through the patients who have agreed to join the 
study. The patients will be asked to give a copy of the PIS to their nominated relative 
with an invitation to take part in the study. The recruiter will then contact the relatives 
who have shown interest in the study. The most appropriate means and period of 
contact will be agreed by the recruiter and the patient who made the nomination. 
The recruiter will receive informed consent from the relatives if they accept to take 
part in the study. 
. 
The recruitment of clinicians will be either by presentations during periodic meetings, 
or through other suitable channels at the Trust sites. 
 
4.2.2 PCUK recruitment 
For recruitment through PCUK, the project (including the PIS) will be advertised 
through PCUK online notice boards, and interested persons will be invited to contact 
the researcher through the BU Clinical Research Unit Patient and Public Involvement 
(BUCRU PPI). If the potential participants meet the inclusion criteria, written informed 
consent will be obtained (via post or email or through face to face contact, whichever 
is convenient). 
 
4.2.3 Recruitment style 
Recruitment will be by stratified sampling which is a subset of purposive sampling 
(Robinson 2014). Stratified sampling is a technique based on defining categories or 
groups of interest, splitting the sample according to these categories, and including 
suitable participants into these categories (Robinson 2014). The theoretical 
foundation for these categories (clinicians, patients, relatives) is explained in the 
shared model of decision making (Charles et al. 1999). 
 

 
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4.2.4 
Stages of recruitment 
Figure 2 and Figure 3 describe the envisaged flow of activity for the two main stages 
of recruitment of participants described in section 3.3. 
 
 
 
Recruit participant
Is Participant = patient, 
doctor, relative?
yes
No
Is particpant = 
clinical nurse 
specialist
start
Conduct interview 
with participant
yes
no
Do we have sufficient 
numbers for focus groups 
(after 1 month)?
no
yes
Is the focus group schedule 
suitable to particpant?
no
yes
Conduct focus with 
participant (4-8 persons 
per group)
Include in evaluation of  
information tool (first 
stage)
end
 
Figure 2: First Stage Recruitment 
 
 
 

 
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start
Recruit participant 
(doctor, nurse, patient, 
relative)
Was participant part of the 
first stage?
yes
no
Include in evaluation 
(second stage)
Is participant = 
doctor, nurse?
no
yes
end
 
Figure 3: Second Stage Recruitment 
4.3 
Pre-registration or randomisation evaluations 
There are no additional screening procedures involved after potential participants 
have been identified by a member of the clinical team. There are no randomisation 
evaluation for this research study. 
 
4.4 
Inclusion Criteria and exclusion criteria 
 
 
Table 1 outlines the inclusion and exclusion criteria for participants of this research. 
 
Table 1: 
Participant inclusion and exclusion criteria 
 
Participant 
Inclusion criteria 
Exclusion criteria 
1. 
Clinician 
(doctors, 
clinical nurse 
specialists) 
Clinicians must have had 
experience of a minimum of one 
consultation with a patient with 
cancer leading to the 
administration of chemotherapy 
Clinicians who have no 
prior experience in 
consultation with 
candidates for 
chemotherapy 
2. 
Patient 
Diagnosed with advanced PC, 
able to speak and understand 
written English, 
18 years or older 
Patients with operable PC, 
Non-English speakers, 
Patients too weak to speak 
or give written informed 
consent, 
Patients lacking mental 
capacity to consent 
 

 
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Participant 
Inclusion criteria 
Exclusion criteria 
3. 
Relative (or 
carer) 
must be involved in, or aware of, 
the decision of the patients in 
choice of treatment, 
should be responsible for the 
provision of support to the 
patient, 
Must 18 years or older, 
Must be able to speak and 
understand written English 
Relative who is not 
involved in the decision-
making process leading to 
treatment selection for the 
patient, 
Relative lacking mental 
capacity to consent 
 
 
4.5 
Withdrawal criteria 
If a participant loses the capacity to consent through severe ill health or other 
reasons, they will be withdrawn from the study. This will be verified by the referring 
oncologist, or other persons acting on behalf of the participants.  Before the 
commencement of each phase of the study, the capacity of participants to consent 
will be assessed by verbally reminding them of the purpose of the research and their 
responsibility, including their ability to leave the study at any time. 
If a participant indicates interest to voluntarily withdraw, they will be withdrawn from 
the study. 
 
5 
Treatment or therapy plan  
5.1 
Description of Treatment or Therapy 
The intervention is a web-based interactive information tool that will be designed to 
provide the relevant information required to guide users in shared-decision-making 
about treatment options available for APC. 
The intervention is not invasive and it will not affect care of participants. 
 
5.2 
Treatment Arms 
This is a single arm study. 
 
6 
Assessment and follow-up 
6.1 
Duration of Treatment or Therapy 
There are no treatments involved this study. 
 
6.2 
Duration of Follow-up 
Not applicable for this study. 
 
6.3 
Subject compliance or Criteria for Removal from Study 
Compliance will be identified by completed and returned forms (whether by post or 
online). Follow-ups will mainly consist of phone calls and/or email reminders which 
will be agreed with participants for non-compliance.  
 
7 
Assessment of safety 
7.1 
Definition  
It is expected that this will be of minimal risk to the participants. However, the 
following issues have been considered. 
 

 
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7.2 
Risks 
Emotional distress is identified as a potential risk when patients and relatives are 
asked to discuss their experiences with respect to APC treatment. To manage this, 
the participants will be made aware of the nature of questions to expect before the 
start of the interviews through a pre-interview briefing with the researcher. They will 
be informed that they are free to pause or suspend their participation if and when 
they feel uncomfortable. Furthermore, contacts of professional counselling support at 
the hospital will be made available to the participants.  
 
7.3 
Burdens 
The burdens for the participants shall be in the form of time spent in the focus groups 
and semi-structured interviews, completing questionnaires, and information tool 
testing. Efforts shall be made to ensure that a maximum of 1 hour is spent in the 
focus groups and the interviews. The filling of questionnaires and information tool 
testing will not exceed 20 minutes and 30 minutes, respectively. Different participants 
(patients and relatives) will be recruited for the Stage 2 of the Test phase (Phase 4). 
The venue of the focus groups shall be the hospitals. Interviews shall be conducted 
at the hospital in the first instance, or by phone, via Skype (or other teleconferencing 
application), or at the residence of participants (patients or relatives), if the other 
options do not meet the desired number of participants. 
 
7.4 
Reporting procedures for Adverse Events 
Not applicable. 
 
8 
Statistics and data analysis 
8.1 
Description of statistical methods  
Following transcription, qualitative data shall be subjected to a thematic data analysis 
approach (Silverman 2014, p.213; Nowell et al. 2017). Nvivo4 software is proposed to 
be used. Nvivo is a software designed for qualitative data analysis. Emerging themes 
shall be elicited from the transcripts of the focus groups and interviews, and these will 
be used to inform understanding of preferences of patients and relatives about 
quality-of-life issues, information needs, and attitudes about the use of a web-based 
information tool. Data from the clinicians will be analysed to provide information on 
the consultation process in APC, the challenges and potential solutions in the 
decision-making phase of APC treatment, and perception about the use of web-
based information tools. 
This phase of data analysis will inform some of the design requirements for the 
proposed information tool. 
Quantitative data is in two forms: (1) network meta-analysis (NMA) of randomized 
controlled trials (RCTs) of phase III chemotherapy regimens in APC from Phase 1, 
and (2) survey questionnaires from Phase 4.  
The choice of software for the NMA is currently being considered. However, there are 
5 major options, namely: R5, Comprehensive Meta-analysis6 (CMA), STATA7, 
Review Manager8, and SPSS9, in the order of decreasing priority. CMA and STATA 
have associated licence fees, but they are the most appropriate tools based on a 
                                               
4 http://www.qsrinternational.com/nvivo/nvivo-products 
5 https://www.r-project.org/ 
6 https://www.meta-analysis.com/pages/why_use.php?cart=BFWF880984 
7 https://www.stata.com/ 
8 http://community.cochrane.org/tools/review-production-tools/revman-5 
9 https://www.ibm.com/analytics/data-science/predictive-analytics/spss-statistical-software 

 
Version 1.0/22 June 2018 
 
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cursory inspection of latest works on NMA. R is also used for NMA and it is freely 
available. 
Quantitative data from Phase 4 can be analysed using either SPSS or R. The 
outcome will be descriptive statistics of the different components of the SDM 
process. Details of the this can be found in the DCS user manual (O'Connor 
1993[updated 2010]) 
 
8.2 
Number of participants 
In sample size determination, it is important to note that, given the resources, 
duration of research study, and participant population, it may be necessary to adopt a 
pragmatic approach, rather than an exhaustive approach.  
In a survey of over 500 PhD projects, Mason (2010) showed that a sample size of  
between 10 to 40 was common for qualitative interviews. For this study, it is 
anticipated that, starting with the minimum recommended size of 10 (per participant 
group) and potentially increasing it to twice that size will be sufficient. In all these 
decisions, ethical principles and the access considerations to participants with 
relevant data are the guiding philosophies (Holloway and Galvin 2016, p.144). 
Proposed sample size for each phase is 
Phase 2 (focus groups, interviews): 
For clinicians, 10-20 participants  
For patients, 10-20 participants  
For relatives, 5-15 participants  
 
Phase 4 (test/evaluation): 
For stage 1, there will be a minimum of 15 tests in total 
(5 clinicians, 5 patients, and 5 relatives) recruited from the participants in Phase 2. If 
the required numbers are not achieved, then new participants will be recruited. 
 
For stage 2, Hertzog (2008) recommended a sample size of 20-25 for a single-group 
instrument efficacy demonstration. Therefore, a total of 30 tests is required to 
account for incomplete/missing data in returned questionnaires. 
The requirements for stage 2 are: the use of the information tool during actual 
clinician-patient consultation about APC treatment and the subsequent data 
collection after the consultation. 
The required participants for each phase of the study is summarised in Table 2. 
 
Table 2: 
Summary of required participants for the study 
 
Participant 
Study phase 
Proposed 
range 
Duration of 
activity 
1 
 
Clinician 
Phase 2 (Focus group or 
semi-structured interviews) 
 
10-20 
1 hour 
Phase 4 (stage 1) 
30 minutes 
Phase 4 (stage 2) 
20 minutes 
2 
 
Patient 
Phase 2 (Semi-structured 
interview) 
10-20 
1 hour 
Phase 4 (stage 1) 
30 minutes 
Phase 4 (stage 2) 
20-30 
20 minutes 
3 
 
Relative 
Phase 2 (Semi-structured 
interview) 
5-15 
1 hour 
Phase 4 (stage 1) 
30 minutes 
Phase 4 (stage 2) 
5-15 
20 minutes 
 
Due to the potential burden on the patients and relatives, and the possibility of health 
deterioration of the patients over the duration of the study, it is envisaged that 

 
Version 1.0/22 June 2018 
 
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participants not previously involved in the study will be recruited for the last stage of 
phase 4 (i.e. stage 2 evaluation). Therefore, about 20-30 participants will be recruited 
(patient-relative mix). However, the clinicians will be invited to participate in all 
stages, except for those that will opt out of any of the phases. In this case, they will 
be replaced with new participants (clinicians).  
 
8.3 
Criteria for termination of the study 
Since this study is low risk and does not interfere with participants’ usual care, 
premature termination of the study is not envisaged. However, in the event of poor 
(or zero) recruitment for some (or all) participant groups, there will be need to review 
the inclusion/exclusion criteria. This will be agreed with the supervisors of the study 
with approval from NHS REC where necessary. 
 
9 
Ethical, Regulatory, Administrative and Quality Assurance 
9.1 
Ethical considerations 
BU sponsorship has been approved for this study. NHS Research Ethics Committee 
(REC) approval will be required as well as BU ethical approval via the Science 
Technology & Health Research Ethics Panel. Data collection will commence after a 
favourable opinion is granted by REC and other approvals have been obtained from 
the participating sites. 
 
9.2 
Declaration of Helsinki 
The study will be conducted in accordance with the recommendations for physicians 
involved in research on human participants adopted by the 18th World Medical 
Assembly, Helsinki 1964 and later revisions 
 
9.3 
Research Governance 
This study will be conducted in compliance to the UK Policy Framework for Health 
and Social Care Research (2017), Good Clinical Practice guidelines, and Good 
Research Practice (MRC 2012). 
 
9.4 
Consent Process 
Informed consent of all participants shall be obtained in keeping with ethical 
guidelines. All prospective participants will be told that participation is voluntary and 
that their participation or otherwise will have no impact on the care that they normally 
receive. Participant Information sheets (PIS) for the research will be provided to the 
prospective participants. The research purpose and contents of the PIS will be 
explained to the prospective participants at the hospital, through email, or on the 
phone, and any queries will be resolved. Interested persons will be given sufficient 
time (a minimum of 24 hours) to decide on joining the study. The informed consent 
process will be concluded by obtaining a written informed consent to indicate 
acceptance in taking part in the study. Consent will be re-confirmed at every new 
phase of the study. 
 
9.5 
Participant confidentiality 
The personal data of participants will not be included in data analysis. To further 
protect the identity of the participants, codes or pseudonyms will be allocated to 
participants and a codebook that associates the participants with the pseudonyms 
will be maintained. This codebook will be securely stored away from the data 
collected during the study.  
Audio recordings are strictly for transcription purposes, and transcriptions will be 
anonymised with the use of pseudonyms. During transcription, any personal data will 

 
Version 1.0/22 June 2018 
 
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be coded. Access to any personal data collected from this study will be restricted to 
the research student and members of the supervision team. All personal data will be 
destroyed after data collection. 
Data storage and protection shall be in line with General Data Protection Regulations 
(GDPR) and Data Protection Act 2018 which stipulates that personally identifiable 
records be securely stored to protect the identity of the owners, and usage of such 
records are clearly made known to their owners during collection. Because this is a 
PhD research, in addition to the Act, the University’s guideline on data storage for an 
academic project shall be adhered to. Only authorised persons (the researcher, 
research supervisors, and regulatory authorities) may have access to the records. 
Secure storage lockers and password-protected computer systems at the university 
will be used to store and manage the collected data. 
 
9.6 
Study Management 
The study will be managed by the PhD researcher. Since it is an educational 
research, it will be co-ordinated from BU. 
 
9.7 
Monitoring 
The research study is monitored by research supervisors who are academic 
members of staff at BU, and a consultant medical oncologist from Poole Hospital 
NHS Foundation Trust. The study may also be monitored by the Clinical Governance 
Advisor within the Research & Knowledge Exchange Office (R&KEO) at BU. 
 
9.8 
Audit and Inspection 
Audit and inspection for this research are both managed by the BU Research Ethics 
Committee and R&KEO. In addition, regulatory authorities may carry out inspections. 
 
10 
Data Handling and record keeping 
Data handling and record keeping will be the responsibility of the PhD researcher. 
Data will be managed in adherence to the GDPR and Data Protection Act 2018. 
The identity of participants will be protected by the use of participant codes in place 
of their names. Other identifying data will not be included in the data analysis. 
Personal data of participants will be stored separately from other data to prevent the 
possible identification of participant data in the study. 
 
10.1 
Archiving 
The study records will be stored for a period of 5 years on the university archive in 
line with Good Clinical Practice guidelines. The IT Services of BU should be 
consulted for authorising destruction of archived materials, in line with the BU Ethics 
Code of Practice: Policy and Procedure (version 2). 
 
11 
Finance, Indemnity and Insurance 
11.1 
Funding 
The research is match-funded PhD study between BU and Poole Hospital NHS 
Foundation Trust. There are no payments for participating in the research. There is 
no additional funding for recruiting centres.  
 
11.2 
Sponsor 
BU is the main sponsor for this study.  NHS Trust sites involved in this study will act 
as participating sites for recruitment, locations for interviews and focus groups, and 
evaluation centres for the web-based information tool. PCUK will act as a recruitment 
site. 

 
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11.3 
Indemnity 
BU Public Liability and Professional Indemnity insurance policies provide an 
indemnity to BU employees for their potential liability for harm to participants during 
the conduct of the research. 
 
This does not in any way affect an NHS Trust’s responsibility for any clinical 
negligence on the part of its staff (including the Trust’s responsibility for BU 
employees acting in connection with their NHS honorary appointments). 
 
BU holds Professional Indemnity insurance to cover the legal liability of the University 
as Research Sponsor and/or as the employer of staff engaged in the research, for 
harm to participants arising from the design of the research, where the research 
protocol was designed by the University. 
 
12 
Publication Policy and Intellectual Property 
Dissemination of results of the study shall be in the form of publications and a thesis 
write-up. Other anticipated forms of dissemination shall be through conference 
presentations and public engagement events related to PC, mixed methods, software 
development, or shared decision-making. Furthermore, there are plans for 
presentations at selected study sites, and the possibility of dissemination through 
PCUK online notice boards. Participants will be informed of this likelihood before they 
sign the informed consent form.  

 
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