STUD Y PRO T O C O L Open Access
Protocol for a feasibility study incorporating
a randomised pilot trial with an embedded
process evaluation and feasibility economic
analysis of ThinkCancer!: a primary care
intervention to expedite cancer diagnosis
in Wales
Stefanie Disbeschl
1*
, Alun Surgey
1
, Jessica L. Roberts
1
, Annie Hendry
1
, Ruth Lewis
1
, Nia Goulden
2
, Zoe Hoare
2
,
Nefyn Williams
3
, Bethany Fern Anthony
4
, Rhiannon Tudor Edwards
4
, Rebecca-Jane Law
1
, Julia Hiscock
1
,
Andrew Carson-Stevens
5
, Richard D. Neal
6
and Clare Wilkinson
1
Abstract
Background: Compared to the rest of Europe, the UK has relatively poor cancer outcomes, with late diagnosis and
a slow referral process being major contributors. General practitioners (GPs) are often faced with patients presenting
with a multitude of non-specific symptoms that could be cancer. Safety netting can be used to manage diagnostic
uncertainty by ensuring patients with vague symptoms are appropriately monitored, which is now even more
crucial due to the ongoing COVID-19 pandemic and its major impact on cancer referrals. The ThinkCancer!
workshop is an educational behaviour change intervention aimed at the whole general practice team, designed to
improve primary care approaches to ensure timely diagnosis of cancer. The workshop will consist of teaching and
awareness sessions, the appointment of a Safety Netting Champion and the development of a bespoke Safety
Netting Plan and has been adapted so it can be delivered remotely. This study aims to assess the feasibility of the
ThinkCancer! intervention for a future definitive randomised controlled trial.
(Continued on next page)
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* Correspondence: stefanie.disbeschl@ bangor.ac.uk
1
North Wales Centre for Primary Care Research (NWCPCR), Bangor University,
Cambrian 2, Wrexham Technology Park, Wrexham LL13 7YP, UK
Full list of author information is available at the end of the article
Disbeschl et al. Pilot and Feasibility Studies (2021) 7:100
https://doi.org/10.1186/s40814-021-00834-y
(Continued from previous page)
Methods: The ThinkCancer! study is a randomised, multisite feasibility trial, with an embedded process evaluation and
feasibility economic analysis. Twen ty-three to 30 general practices will be recruited across Wales, randomised in a ratio of 2:1
of intervention versus control who will follow usual care. The workshop will be delivered by a GP educator and will be
adapted iteratively throughout the trial period. Baseline practice characteristics will be collected via questionnaire. We will
also collect primary care intervals (PCI), 2-week wait (2WW) ref erral rates, conve rsion rates and detection rates at baseline and
6 months post-randomisation. Participant feedback, researcher reflections and economic costings will be collected following
each workshop. A process evaluation will assess implementa tion us ing an adapted Normalisation Measure Development
(NoMAD) qu estionnaire and qualitative interviews. An economic feasibil ity analysis will inform a future economic evaluati on.
Discussion: This study will allow us to test and further develop a novel evidenced-based complex intervention aimed at
general practice teams to expedite the diagnosis of cancer in primary care. The results from this study will inform the future
design of a full-scale definitive phase III trial.
Trial registration: ClinicalTrials.gov NCT04823559.
Keywords: Early cancer diagnosis, Feasibility, Primary care, General practitioners, Safety netting, Health economics, Process
evaluation
Introduction
Background
Cancer survival in the UK lags behind other western
countries [1]. Referral rates and adherence to guide-
lines are lower [2, 3], primary care providers (PCPs)
are less likely to take action on potential cancer
symptoms [4] and cancer tends to be diagnosed at a
later stage, often only after patients have presented
to acute or emergency secondary care services [3 ].
Compared with the rest of Europe, the UK has rela-
tively low 1-year survival, which could be due to later
diagnosis [5].
Timely diagnosis is key to improving cancer outcomes
[6] and cancer survival [7]. Earlier diagnosis could also
reduce the proportion of cancer patients diagnosed
through emergency care [7]. Early diagnosis is a rising
priority in cancer policy [6, 8], because it is cost-effective
[1] and the incidence of cancer is increasing [9]. Polic ies
in Wales emphasise the importance of early diagnosis
and recognise that increasing demand and a slow referral
process are significant barriers to a quick cancer diagno-
sis [3]. Following the implementation of these policies,
progress has been slow, with late stage diagnosis con-
tinuing to be an issue [10].
The timely diagnosis of cancer has become even more
relevant as we enter a period in which primary care and
cancer management have changed dramatically due to
the ongoing COVID-19 pandemic [11–13]. Early figures
have shown a 76% decrease in urgent cancer refer rals
across the UK and predict a 20% increase in excess
deaths for patients with newly diagnosed cancers [14].
The increased use of remote consultation as a result of
the pandemic will have implications for the early diagno-
sis of cancer, as important consultation techniques such
as the use of visual cues and physical examination [15]
may be impacted.
Primary care providers (PCPs) play a vital role in the
early diagnosis of cancer [16]. A key diagnostic stage is
the Primary care interval (PCI), whic h is the time from
first presentation to a GP with a symptom that could be
cancer, to the subsequent referral to a specialist in sec-
ondary care [17]. However, with an ever expanding role,
PCPs are presented with a plethora of non-specific
symptoms, of which only a small proportion are caused
by cancer, and many overlap with other diseases [6].
Furthermore, with certain cancers, patients may not
present with any alarm symptoms [6, 16] which often re-
sults in a delayed cancer diagnosis [2]. In addition,
guidelines to expedite early cancer diagnosis are often
unclear, with great variation in strategies between differ-
ent GPs [18].
Rationale and previous work
This study comprises work package 4 of the Wales In-
terventions for Cancer Knowledge and Early Diagnosis
(WICKED) programme. Work package 1 consisted of a
review of reviews and a realist review, Work Package 2
comprised qualitative interviews with 20 GPs, four focus
groups with primary care practice staff, and a combined
quantitative survey and Discrete Choice Experiment
(DCE), sent to GPs in Wales. The data garnered from
work package s 1 and 2 fed into the development of the
intervention (work package 3) via the Behaviour Change
Wheel (BCW) [19]. A target behaviour was identified—
GPs thinking of and acting on clinical presentations that
could be cancer—and through application of the BCW,
education and training, enablement and restructuring of
the environment were selected as intervention functions.
The findings of the earlier work packages and the devel-
opment of the intervention are described in more detail
elsewhere [20].
Disbeschl et al. Pilot and Feasibility Studies (2021) 7:100 Page 2 of 17
Clinical behaviour change interventions targeting PCPs
have the potential to address barriers to suspected can-
cer identification and referral and could expedite the
diagnosis of ca ncer and improve cancer outcomes over-
all [21]. Behaviour change at PCP level can be achieved
through various mechanisms, including feedback, elec-
tronic prompts and training [22–24]. Financial incen-
tives have also been found to be effective, but once
withdrawn may lead to a drop in the quality of care [25].
There is some evidence that educational interventions
targeted at PCPs could reduce the PCI, providing they
encompass a multidimensional, interactive and tailored
approach [21, 26, 27]. A recent systematic review of pri-
mary care interven tions suggested that a whole-practice
approach providing opportunities for peer review and
feedback could have a positive effect on referral
practices, in addition to existing guideline s being revis-
ited through training and reinforcement [28]. This was
also confirmed by the findings of the qualitative work in
the previous WICKED work packages, where GPs
highlighted positive practice culture and a whole-
practice approach as important themes [20].
While the timely diagnosis of cancer is crucial, urgent
referral can lead to over-diagnosis and over-investigation
which can be harmful to the patient [7, 29]. This risk is
especially high if the patient presents with vague symp-
toms [30]. Safety netting, a tool used to manage diagnos-
tic uncertainty [31], can address these issues by ensuring
that patients with non-specific symptoms are not ig-
nored [29, 32]. Instead of immediate referral, patients
are monitored according to a set step-wise investiga-
tional plan, while ensuring they are referred in a timely
manner as and when required [29, 32]. Although safety
netting is currently recommended by national guidelines
[33], there are no clear recommendations on how to do
it [18, 29, 31, 32].
In summary, it is relevant and befitting to develop and
test interventions aimed at improving the quality and
consistency of primary care approaches to ensure timely
diagnosis of cancer in the UK. This will require multi-
component and complex behavioural change interven-
tions, which utilise a multidimensional, interactive,
tailored, whole-practice approach.
The ThinkCancer! interventio n is a complex behaviour
change intervention aimed at general medical practice
teams. It consists of a multi-component workshop that
includes educational early diagnosis and awareness ses-
sions, evaluation of current practice-based safety netting
systems and the appointment of a safety netting cham-
pion. The workshop will be led by an educational facili-
tator who will guide the development of a bespoke safety
netting plan for each practice.
The aim of this study is to assess the feasibility of de-
livering the ThinkCancer! intervention and conducting a
future, definitive randomised UK-wide controlled trial
(RCT) to assess effectiveness and cost-effectiveness, in
order to establish whether the intervention can be rolled
out in practice.
Study objectives
The objectives of this study are as follows:
1) To assess the feasibility of a future definitive RCT
by monitoring recruitm ent and retention, outcome
measure completion and reasons for decline.
2) To assess the acceptability, feasibility, and utility of
the ThinkCancer! intervention as a whole and of
each of its individual components, and refining the
intervention as necessary.
3) To determine the most feasible and appropriate
primary outcome measur e for a definitive RCT and
producing means and confidence intervals for
calculating effect sizes for the design of a definiti ve
trial.
4) To describe current contextual differences, and
similarities, between general medical practices and
their usual safety netting practices.
5) To identify and test the methods and outcome
measures for a process evaluation of a future
definitive RCT.
6) To undertake a feasibility ana lysis of the most
appropriate approach for an economic evaluation
alongside a future definitive trial.
Methods
Study design
This feasibility study incorporates a pragmatic, multisite,
two-armed, superiority, pilot RCT. There is an embed-
ded process evaluation and feasibility economic analysis.
The unit of random isation is the general medical prac-
tice, and the primary clinical outco me is collected at the
practice level.
The term ‘feasibility’ is used in accordance with the
conceptual framework developed by Eldridge and col-
leagues [34], where it is described as an umbrella term
within which pilot trials are a component. Furthermore,
the study has been designed in accordance with the
MRC Framework for evaluating complex interventions
[35]. The trial will be conducted according to NIHR
guidance [36] and recommendations for good practice in
pilot studies [37].
The process evaluation, which will be based on a
mixed-methods approach, will follow the MRC guidance
for process evaluations of complex interventions [38].
During the initial piloting or feasibility testing stage of
an intervention, process evaluation has a vital role in
understanding and planning the future potential
Disbeschl et al. Pilot and Feasibility Studies (2021) 7:100 Page 3 of 17
implementation of the intervention and optimising its
design and evaluation [38].
The feasibility economic analysis will explore the ap-
propriate future perspective of analysis, most appropriate
methods of gathering costs, and range and value of out-
come measures and undertake a feasibility budget im-
pact analysis of the ThinkCancer! intervention developed
through a range of blended methods that it is delivered
online (either in a live format or pre-recorded) or face-
to-face in general practices across north Wales.
This study protocol was developed in line with the
Standard Protocol Items: Recommendations for Inter-
ventional Trials (SPIRIT) guidelines [39]; the SPIRIT
checklist (Appendix 1) and the schedule of procedures
can be seen in Table 1. The SPIRIT checklist has been
adapted in accordance with the CONSORT extension to
pilot and feasibility trials [40].
Study setting
The setting for this stud y is primary care. The interven-
tion will be delivered in-prac tice or online to individual
general medical practices and incorporates a whole-
practice approach. The trial will be conducted across
Wales and practices will be recruited from all seven
Welsh health boards.
Intervention
The proposed intervention, the ThinkCancer! workshop,
has four chief components. The first are two educational
sessions, one for all clinical staff (the ‘early diagnosis’
session) and one for non-clinical but patient-facing staff
(the ‘cancer aware’ session). The early diagnosis session
is delivered as a teaching seminar with learning out-
comes focussed on NICE NG12 Suspected Cancer: rec-
ognition and referral guidelines [27], hot topics
exploring the harder to recognise cancer presentations
and consultation-level safety netting. As a proposed aid
to support and formalise safety netting, a new tool—the
Shared Safety Net Action Plan (SSNAP) [41] will be in-
troduced. The SSNAP tool is a co-produced patient-
facing information leaflet that can be used by a clinician
to give specific safety netting advice to a patient about
when and how they should re-present for further med-
ical assessment [41]. This tool can be used in support of
patients who present with ‘low risk, but not no risk’
symptoms or in situations where it would be too soon to
trigger an urgent referral or diagnostic investigation.
Proposed benefits of the tool include increasing patient
empowerment to navigate primary care systems in gain-
ing follow-up appointments, and by keeping copies of
the tool within the patient record, better record advice
and guidance given. This session will also see the intro-
duction of the ThinkCancer! handbook, which will con-
tain all the resources used in the workshop as well as
external resources regarding early diagnosis and safety
netting, such as NICE guidance and online learning re-
sources. The cancer aware session is less formal with
more convenor-l ed discussion around cancer red flag
symptoms that non-clinical staff may encounter. The
secondary aim of this session is to gauge and explore is-
sues and norms around raising concerns within the
practice team. The third session (the ‘safety netting ses-
sion’) involves the two final components of the interven-
tion, the co-production of a bespoke Cancer Safety
Netting Plan (CSNP) and appointment of a Cancer
Safety Netting Champion (CSNC). This session is
attended by a combination of clinical and administrative
staff who will be involved in the design and implementa-
tion of a new plan. The CSNP will evolve from discus-
sions built on three components, learning from the
earlier educational parts of the workshop, evaluation of
the current practice safety nettin g systems reported in
the practice questionnaire and the attendee’s personal
reflections of cancer diagnosis and safety netting. Fol-
lowing this discussion, a summary document highlight-
ing potential new action points will be sent back to the
practice for them to take forward and develop. Success
in developing and implementing a new practice plan
may be increased by the appointment of a champion to
drive change and therefore the appointment of a CSNC
is explored during this part of the workshop.
Members of the research team will deliver the inter-
vention; the GP Educator (AS) will oversee the work-
shop, supported by up to two researchers. The
workshop was originally designed to be delivered face-
to-face in participating practices during practices’ allo-
cated protected time for educational and professional
development. However, due to the ongoing COVID-19
pandemic, the workshop has been adapted into a digital
format and can be delivered in one of three ways: (i)
fully remote and live via online conferencing platforms;
(ii) blended delivery, where practices are offered a com-
bination of pre-recorded versions and live remote deliv-
ery of the different sessions; and (iii) face-to-face in the
practice, as originally intended, if the situation allows.
Practices that opt for the blended delivery of the work-
shop can choose to receive pre-recorded videos of ses-
sions 1 and 2, presented by the GP Educator, allowing
participants to engage with the materials in their own
time. The final session, which focuses on the Cancer
Safety Nettin g Plan, will still need to be delivered as a
live session due to its intera ctive components. There will
be flexibility to work with the practice to allow the be-
spoke design of the workshop format to improve the
reach of the intervention. Practices receiving the inter-
vention in any of the remote forms will be sent all of the
workshop materials, including the handbook and SSNAP
tool, via post. If there is the possibility to deliver the
Disbeschl et al. Pilot and Feasibility Studies (2021) 7:100 Page 4 of 17
Table 1 SPIRIT protocol schedule of procedures for the ThinkCancer! study
Disbeschl et al. Pilot and Feasibility Studies (2021) 7:100 Page 5 of 17
