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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

03 Dec 2020-medRxiv (Cold Spring Harbor Laboratory Press)-

TL;DR: 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 and inform the future design of a full-scale definitive phase III trial.

AbstractBackground Relative 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. Methods The ThinkCancer! study is a randomised, multisite feasibility trial, with an embedded process evaluation and feasibility economic analysis. Twenty-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), Two Week Wait (2WW) referral rates, conversion rates and detection rates at baseline and six months post-randomisation. Participant feedback, researcher reflections and economic costings will be collected following each workshop. A process evaluation will assess implementation using an adapted Normalisation Measure Development (NoMAD) questionnaire and qualitative interviews. An economic feasibility analysis will inform a future economic evaluation. 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 registratio intended registry: clinicaltrials.gov

Topics: Referral (51%)

Summary (8 min read)

Background

  • Cancer survival in the UK lags behind other western countries [1].
  • Referral rates and adherence to guidelines 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 relatively low 1-year survival, which could be due to later diagnosis [5].
  • The timely diagnosis of cancer has become even more relevant as the authors enter a period in which primary care and cancer management have changed dramatically due to the ongoing COVID-19 pandemic [11–13].
  • 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].

Rationale and previous work

  • This study comprises work package 4 of the Wales Interventions for Cancer Knowledge and Early Diagnosis 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.
  • Behaviour change at PCP level can be achieved through various mechanisms, including feedback, electronic prompts and training [22–24].
  • This risk is especially high if the patient presents with vague symptoms [30].
  • The workshop will be led by an educational facilitator who will guide the development of a bespoke safety netting plan for each practice.

1) To assess the feasibility of a future definitive RCT by monitoring recruitment 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 measure for a definitive RCT and producing means and confidence intervals for calculating effect sizes for the design of a definitive trial.
  • 4) To describe current contextual differences, and similarities, between general medical practices and their usual safety netting practices.

Study design

  • This feasibility study incorporates a pragmatic, multisite, two-armed, superiority, pilot RCT.
  • There is an embedded process evaluation and feasibility economic analysis.
  • The unit of randomisation is the general medical practice, and the primary clinical outcome is collected at the practice level.
  • The process evaluation, which will be based on a mixed-methods approach, will follow the MRC guidance for process evaluations of complex interventions [38].
  • This study protocol was developed in line with the Standard Protocol Items: Recommendations for Interventional Trials guidelines [39]; the checklist and the schedule of procedures can be seen in Table 1.

Study setting

  • The setting for this study is primary care.
  • The intervention will be delivered in-practice or online to individual general medical practices and incorporates a wholepractice 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 third session (the ‘safety netting session’) involves the two final components of the intervention, the co-production of a bespoke Cancer Safety Netting Plan (CSNP) and appointment of a Cancer Safety Netting Champion (CSNC).
  • Members of the research team will deliver the intervention; the GP Educator (AS) will oversee the workshop, supported by up to two researchers.

Outcome measures

  • The outcomes that will be reported in this feasibility study are as follows: Recruitment will be assessed quantitatively by capturing the numbers of practices ▪.
  • The feasibility of using potential clinical primary outcomes, 2WW referral rate, PCI, conversion rates, and detection rates will be assessed quantitatively by determining: ▪ Ability to collect/capture data from the practices, based on completion rates of data collection forms ▪.
  • The number of practices that actively nominate a safety netting champion ▪.
  • For the health economics component, the authors will do the following: ▪ Determine the feasibility of collecting data relating to the costing of the intervention via costings forms ▪.
  • Review relevant literature on the cost-effectiveness of online and mixed-methods Continuing Professional Development (CPD) programmes for health professionals in a community setting ▪ Consult the DIRUM database [44] to identify the most appropriate way of capturing the costs of the ThinkCancer!.

Progression criteria

  • The outcome measures relating to recruitment, retention and adherence/fidelity will be assessed using RAG criteria, as defined below: 1. Confirmation of adequate recruitment for a definitive trial at practice level.
  • Confirmation of adequate retention for the definitive trial at practice level.
  • At least 50% of the clinical staff should attend the workshops; b. Progression criteria relating to obtaining data regarding completion of outcome measures will be assessed using the following progression criteria: 1. Routine data.
  • Go: data from 70% or more of individuals of each practice obtained; Review: data from < 70% of individuals from each practice obtained.

Sample size

  • The authors aim to recruit 23–30 general medical practices.
  • The maximum that was considered possible to recruit is 30 practices.
  • Practices will be randomised using a randomisation allocation ratio of 2:1 of intervention versus control.
  • This is discussed further under statistical analyses.

Recruitment

  • General practices will be identified through contact details publicly available via practice websites and through contact lists provided by the health boards across Wales.
  • Practices will be invited to participate using a standardised invitation via email addressed to the practice manager, along with information about the study.
  • They will also need to advise of their practice’s availability for potential workshop dates.
  • Staff members involved in the design and implementation of a new cancer safety netting plan can consider using this as the basis of a quality improvement project for revalidation and appraisal purposes.
  • The authors are aware that some challenges in the recruitment lay ahead, but they plan to work with the various research infrastructures in Wales to overcome this.

Eligibility to participate

  • As feasibility is the main objective of this study, all types of general medical practice will be eligible for inclusion.
  • This will aid intervention refinement and allow for a better understanding of what is feasible across a range of practices and also why some practices may not be able to take part.

Inclusion

  • Any general practice in Wales is eligible for inclusion.
  • The target audience for the intervention, based on a ‘whole team approach’, includes all practice staff members.
  • These may include, for example, GPs, nurse practitioners, nurses, health care support workers , practice managers, administrators, receptionists or any other practice staff, clinical and non-clinical.
  • Practices participating in other research are also eligible for inclusion; they will be asked to notify us of any cancer-related studies they may be participating in via the baseline questionnaire.

Pre-trial pilot

  • Pilot workshop prior to full rollout of the feasibility study.
  • The practice is an urban, large 12,000 patient training practice in a moderately deprived region of North East Wales.
  • Data will not be collected or recorded for trial purposes and feedback from those participating will only be used to refine the intervention prior to its delivery across recruited practices.

Randomisation and blinding

  • The general medical practice will be the unit of randomisation.
  • Randomisation will be achieved online, through the remote randomisation centre at the North Wales Organisation for Randomisation Trials in Health at Bangor University.
  • The randomisation system will use a dynamic adaptive allocation algorithm [45] to achieve randomisation, stratified for health board.
  • ThinkCancer! is an open trial where blinding of participants, researchers and the statistician is not possible due to the nature of the intervention and 2:1 ratio for randomisation.

Withdrawal criteria

  • Practices (and individuals within a practice) will be free to withdraw from the trial at any time, and their right to refuse participation will be respected throughout.
  • The authors will seek to understand their reasons where possible.

Data collection

  • The feasibility study will be used to rehearse data collection approaches and assess their ease of use.
  • All data collected in this study will be anonymised.
  • Two-week wait referral data and PCI data will be collected directly from participating practices via Case Report Forms containing full instructions on how to extract the data from practice IT systems.
  • The authors will work with the Practice Manager, CSNC or other delegated individuals to achieve this.

Practice questionnaires

  • The baseline and endline practice questionnaires will be available online to both intervention and control practices and are to be filled out by the practice manager or other designated person, ideally in collaboration with the practice team; SurveyMonkey™ will be the most likely platform.
  • The baseline data may be used to inform some workshop planning—i.e. workshop content and delivery may be tailored to some extent to suit individual practice needs and circumstances.
  • Baseline measures will include the following: ▪ Demographic information and practice characteristics (practice size, research-accredited status, number of clinical and non-clinical staff members, whether a teaching practice, etc.) ▪ Practice culture (e.g. team structure, diversity of team member roles, team decision-making processes) ▪.
  • Practice knowledge with regard to safety netting and cancer awareness ▪.
  • How widely they are used within the practice ○.

Feasibility and piloting data

  • Recruitment, retention and questionnaire completion numbers will be recorded throughout the trial.
  • Spreadsheet systems will be put in place to record practice responses and to track their progress in the trial (e.g. number of practices approached, whether they have responded to the initial invitation, whether they have agreed to be randomised, etc.).
  • The same research team members will deliver the intervention in all practices; their observations will be collected and will inform any refinements of the intervention.
  • Observations and reflections recorded by the research team may provide valuable data on the potential effects of contextual factors, site-by-site and componentby-component measures, and the appropriateness of individual questions included in the practice questionnaires.
  • They will also describe the cancer safety netting plan proposed by the practice and whether the SSNAP tool is used.

Health economics

  • Health economics data collection sheets will be completed by the researchers following each workshop, and costings specific to the practice will be recorded.
  • The authors will also use the feedback forms to determine staff roles within the practice for costing purposes.

NoMAD instrument

  • At least 2 months after the intervention, participants who consented to be contacted will be sent a link to complete an adapted Normalisation Measure Development instrument [48].
  • This will assess the implementation of the cancer safety netting plan using Normalization Process Theory (NPT) principles, which may or may not include the SSNAP tool depending on uptake.

Telephone interviews

  • Practice staff in both arms of the trial will be eligible to participate in the interviews as they will be invited to give feedback on all aspects of the trial process including the intervention where appropriate.
  • The interviews will allow participants to explain how they were able to utilise aspects of the trial and how they worked in practice.
  • Informed consent will be obtained and interviews recorded and transcribed verbatim.
  • Topics may include acceptability, safety netting, data collection, uptake of the intervention and SSNAP tool and implications.
  • These interviews will occur at least 2 months after the intervention has taken place; control practices will be invited two months postrandomisation.

Adverse events

  • A risk assessment has found this trial to be low risk.
  • Participating practices are encouraged to report any adverse events.
  • The Chief Investigator (CI) will determine whether they are Adverse Events (AEs) or Serious Adverse Events (SAEs).
  • They will be reported in line with current ICH-GCP Standard Operating Procedures [49].
  • The authors do not expect any related SAEs for this study.

Quantitative analysis

  • A fully documented statistical analysis plan will be prepared by NWORTH, a registered clinical trials unit, and agreed by the co-investigators and approved by the trial governance structure, which will be known as the Trial Steering Committee (TSC).
  • The statistical analysis plan will be approved prior to data collection being completed.
  • Feasibility and process evaluation data such as practice recruitment rate, implementation and uptake of and adherence to the intervention, and follow-up rates will be summarised and presented as percentages.
  • Exploratory analysis using ANCOVA for continuous outcomes and logistic regression for binary outcomes will consider adjustment for the stratification variables in assessment of the treatment effects.
  • As this is a feasibility study, there will be no imputation of missing data over and above any scoring rules established for the outcomes.

Economic analysis

  • Alongside the statistical analysis plan, a Health Economics Analysis Plan (HEAP) will be produced setting out the objectives and methods for data collection and analysis of the health economics findings [50].
  • The HEAP will be signed-off by the lead health economist and CI prior to any data being shared with the health economics researchers.
  • In micro-costing, each component of resource use is estimated and then a unit cost is derived using 2019 national reference costs (in Great British Pounds Sterling) where available [51–53].
  • In addition and separately, the costing of the development of the ThinkCancer!.
  • Intervention will be determined based on the following: ▪ Online delivery format—live seminars/webinars, staff time and materials, exploration of whether health professional time should be collected in a full trial to reflect the co-production nature of CPD in own time or reflecting the opportunity cost of CPD in terms of time not spent on direct patient care activities.

Qualitative analysis

  • The transcribed telephone interviews, the free text responses from the feedback forms and the observational data, in text form, will be analysed for the process evaluation using Framework Analysis [54].
  • Framework is a five-stage matrix-based system for analysing qualitative data which is highly appropriate for a feasibility study which is iterative in its development.
  • Initially, all transcripts and textual data will be read thoroughly by the same researcher who conducted the interviews to achieve data familiarisation and immersion.
  • An index of emergent themes will then be created and data coded according to the index.
  • The completed charts will then be used for final stage which is in-depth interpretation [54].

Trial management

  • The study will be supported by the North Wales Organisation for Randomised Trials in Health , which is a fully registered Clinical Trials Unit.
  • Therefore, the monitoring of data will have a more internal focus in the form of self-audits to ensure compliance with regulations.

Operational group

  • The operational working group will be responsible for the overall conduct, supervision and progress of the study.
  • They consist of the immediate research team, supported by a wider group of experts.

Trial management group

  • The trial management group (TMG) will meet once a month, consisting of the operational group and a wider team of experts, including a PPI member.
  • The group will be responsible for the overall management of the trial and ensuring the study adheres to the protocol.

Trial governance structure

  • A Trial Steering Committee (TSC) committee will provide independent oversight for the study, ensuring it is conducted according to the standards set out by the HRA Research Governance Framework [55].
  • As the study includes an element of ongoing intervention refinement and is deemed low risk with very minimal likelihood of stopping early due to patient safety, a Data Monitoring and Ethics Committee (DMEC) will not be required [56].
  • Meetings are expected to be biannual and the Sponsor and Funder will be updated following each meeting.
  • The TSC will have an independent chairperson (Aneez Esmail) and at least three independent members including Patient and Public Involvement (PPI) representation, trial co-applicants, a statistician (Rhian Gabe), a health economist (Laura Ternent) and other independent members.

Data management

  • A detailed data management plan will be written by NWORTH staff and approved as soon as possible following commencement of data collection, if not before.
  • This plan will include the definition of the data quality checks that will be performed on the data throughout the life course of the trial.
  • These will include source data validation, random data checks and timelines for data entry.

Quality control

  • Quality control will be maintained through adherence to the study protocol, Betsi Cadwaladr University Health Board/Bangor University Standard Operating Procedures (SOPs), principles of Good Clinical Practice, research governance and clinical trial regulations.
  • All investigators, trial site and research staff will comply with the requirements and regulations of the EU General Data Protection Regulation 2018 (GDPR) regarding the collection, storage, processing and disclosure of personal information and will uphold the Regulation’s core principles.
  • All research staff involved will have up to date GCP training.
  • Research data will be retained as per the Sponsor’s research data management policy.

Data archiving

  • As per the Sponsor’s research data management policy, research data and records will be archived along with the data management policy of the Sponsor.
  • In line with legal requirements, trial documents will be archived centrally at a secure facility with appropriate environmental controls and adequate protection from fire, flood and unauthorized access.
  • Archived material will be stored in tamper-proof archive boxes that are clearly labelled.
  • Electronic archiving will be provided by the Sponsor for post-project deposit and retention of data.
  • Destruction of essential documents will require authorisation from the Sponsor.

Dissemination policy

  • On completion of the study a final report will be prepared for Cancer Research Wales.
  • Findings will be disseminated through various media, including open-access peer-reviewed publications, national and international conferences, the programme web pages, social media, and through an end-ofprogramme symposium for key stakeholders.
  • Findings will also be disseminated to participating practice teams via a newsletter.
  • Publications arising directly from the WICKED programme and authorship on the final trial report will adhere to the BMJ guidelines on authorship and contribution, based on the International Committee of Medical Journal Editors Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals 2013 [57].

Patient and public involvement

  • The study team recognises that the involvement of those with lived experiences will be vital in this research.
  • Furthermore, a lay perspective is essential in the development and undertaking of research for the promotion of equality, diversity and transparency.
  • Additionally, the trial PPI has been active in providing feedback on participantfacing documents.
  • Two more PPI representatives have been recruited to the TSC through the North Wales Cancer Forum and have directly relevant experience.
  • Their perspective as both a patient and a member of the public will inform the overall supervision of the trial.

Discussion

  • This study aims to test the feasibility of the ThinkCancer! intervention.
  • The authors acknowledge that interventions aiming to increase cancer referrals bring with them a risk of over-diagnosis and overinvestigation of patients.
  • Safety netting can minimise the risk of harm by ensuring referrals are appropriate [7, 29, 32].
  • To their knowledge, there are no interventions targeting primary care with a focus on safety netting.

Trial status

  • The trial is currently open for recruitment.
  • On sites that are not covered by the NHS Indemnity Scheme (e.g. GP surgeries in primary care), investigators/collaborators will need to ensure that their activity on the study is covered under their own professional indemnity.
  • SD drafted the manuscript integrating comments from JR, AS, AH, NG, CW, RN, NW, RTE, BFA, RL, RJL and ACS.
  • ZH was involved in the design of the study and contributed to the protocol via the statistical component and the outcome measures.
  • RJL was involved in the intervention development and the previous work packages leading up to the ThinkCancer trial.

Declarations

  • Ethics approval and consent to participate 2North Wales Organisation for Randomised Trials in Health , Bangor University, The Normal Site, Holyhead Road, Gwynedd LL57 2PZ, UK.
  • Round T. Primary care and cancer: facing the challenge of early diagnosis and survivorship.

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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)
© The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License,
which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give
appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if
changes were made. The images or other third party material in this article are included in the article's Creative Commons
licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons
licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain
permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the
data made available in this article, unless otherwise stated in a credit line to the data.
* 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 [1113]. 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 cancerand 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 [2224]. 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 toolthe
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 attendees 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

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TL;DR: The Medical Research Council's evaluation framework (2000) brought welcome clarity to the task and now the council has updated its guidance.
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Abstract: The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

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TL;DR: The systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 is described, a guideline for the minimum content of a clinical trial protocol.
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Related Papers (5)
Frequently Asked Questions (2)
Q1. What are the contributions in "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" ?

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. This study aims to assess the feasibility of the ThinkCancer ! ( Continued on next page ) © The Author ( s ). This article is licensed under a Creative Commons Attribution 4. 0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author ( s ) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article 's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article 's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. Org/licenses/by/4. 0/. The Creative Commons Public Domain Dedication waiver ( http: //creativecommons. org/publicdomain/zero/1. 0/ ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Ac. uk 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. 

One of the key strengths of this intervention is that it can be iteratively developed throughout the study period, which will ensure the future definitive trial will adopt an optimal approach. In addition, involving the entire practice is a relatively novel approach, with great potential benefit.