'ThinkCancer!' A trial to see if educational and behavioural workshops can help your general practice team to pick up symptoms and signs of possible cancers as quickly as possible, by referring on to a specialist

ISRCTN	ISRCTN43757325
DOI	https://doi.org/10.1186/ISRCTN43757325
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	316593
Protocol serial number	IRAS 316593
Sponsor	Bangor University
Funders	Cancer Research Wales, North West Cancer Research

Submission date: 27/01/2023
Registration date: 16/02/2023
Last edited: 06/03/2025

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Cancer diagnosis can be delayed in primary care. Our goal is to help general practices recognise possible cancers earlier which will lead to better outcomes for patients.
We have developed a unique educational and behavioural package called ‘ThinkCancer!’. This involves three workshops for all staff in a practice team. We have tested ‘ThinkCancer!’ in a small pilot study in Wales, which showed that it can work well in primary care. We learnt important lessons about how the workshops should be delivered, and the best ways to collect information from practices.
Our aim now is to undertake a larger trial with 76 practices to test how well ThinkCancer! works and whether it is cost effective for the NHS. We will assess the effect of ThinkCancer! by measuring the time between a patient first contacting their general practice with a potential cancer symptom and their referral to hospital. A reduction in this time is known to be linked with earlier stage of cancer at diagnosis, needing less treatment, and costing the NHS less overall.
We have worked closely with patients throughout the development of ThinkCancer! and will form a Patient Advisory Group of four to six patients who will help ensure that patient views are fully represented as we interpret the results.

Who can participate?
General practices will primarily be recruited from Wales, topped up with practices from North West of England. We will recruit 8-10 practices from each of the seven Health Boards in Wales, and 8-10 from North West England.

What does the study involve?
Half of the practices will be randomly allocated to receive the intervention.
ThinkCancer! is a whole practice-based behavioural change complex intervention that aims to raise awareness and increase knowledge around current cancer diagnosis guidance. The intervention is delivered remotely as an educational and quality improvement workshop, via three distinct workshops. The first two workshops are educational sessions, one for all clinical staff (the ‘early diagnosis’ session) and one for non-clinical but patient-facing staff (the ‘cancer aware’ session), allowing exposure to the intervention for all members of practice staff who interact with patients or their carers/advocates in any way. The third session (the ‘safety netting session’) involves the final components of the intervention, the co-production of a bespoke Cancer Safety Netting Plan (CSNP) and the appointment of a Cancer Safety Netting Champion (CSNC).

What are the possible benefits and risks of participating?
In terms of the benefits of the 'ThinkCancer!' intervention at the practice level, better safety netting systems for general practices may result in fewer errors in early cancer diagnosis, and better knowledge and appropriate referral thresholds for GPs may result in more timely and accurate urgent suspected cancer referrals. The whole practice approach to recognising symptoms and signs of cancer includes the GP administrative staff, some of who, might feel uncomfortable with this role. Due to the sensitive nature of the topic, there is a chance that the patient/carer may experience distress during the interview.

Where is the study run from?
Bangor University (UK)

When is the study starting and how long is it expected to run for?
January 2023 to August 2026

Who is funding the study?
Cancer Research Wales and North West Cancer Research (UK)

Who is the main contact?
thinkcancer@bangor.ac.uk

Contact information

Prof Clare Wilkinson
Principal investigator

North Wales Centre for Primary Care Research
Bangor University
Cambrian 2
Wrexham Technology Park
Wrexham
LL13 7YP
United Kingdom

ORCID ID	0000-0003-0378-8078
Phone	+44 1248351151
Email	c.wilkinson@bangor.ac.uk

Study information

Primary study design	Interventional
Study design	Phase III multicentre pragmatic randomized controlled trial with embedded economic evaluation and process evaluation
Secondary study design	Cluster randomised trial
Participant information sheet	43125_PIS_control_V6_10Jan23.pdf
Scientific title	ThinkCancer!: A pragmatic randomised controlled phase III trial of a novel behavioural intervention for primary care teams to promote earlier cancer diagnosis with embedded process and economic evaluation
Study acronym	ThinkCancer!
Study objectives	The 'ThinkCancer!' general practice based workshop series enable earlier cancer diagnoses more effectively than usual care
Ethics approval(s)	1. Approved 15/03/2023, Healthcare Sciences (Post-reg) Ethics and Research Committee (College Road, Bangor, ll572dg, United Kingdom; 01248 383136; healthethics@bangor.ac.uk), ref: 2022-17267 2. Approved 23/08/2023, Health Research Authority IRAS application (Health Research Authority, 2 Redman Place, Stratford,, London, E20 1JQ, United Kingdom; 0207 104 8000; approvals@hra.nhs.uk), ref: IRAS project ID: 316593
Health condition(s) or problem(s) studied	Early diagnosis of cancer in primary care
Intervention	ThinkCancer! is a whole practice-based behavioural change complex intervention that aims to raise awareness and increase knowledge around current cancer diagnosis guidance. The intervention is delivered remotely as an educational and quality improvement workshop, via three distinct workshops. The first two workshops are educational sessions, one for all clinical staff (the ‘early diagnosis’ session) and one for non-clinical but patient-facing staff (the ‘cancer aware’ session), allowing exposure to the intervention for all members of practice staff who interact with patients or their carers/advocates in any way. The third session (the ‘safety netting session’) involves the 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).
Intervention type	Behavioural
Primary outcome measure(s)	1. Primary care interval (PCI - time between first presentation of potential cancer to primary care and referral to secondary care) data. Collected retrospectively by GP research staff or trained nurses, using a Case Report form, for the period 14 to 26 months post-randomisation. 2. Cost-effectiveness in terms of incremental cost per day reduction in PCI and budget impact, collected via health economics data collection sheets/diaries after each GP-educator training event and practice workshop
Key secondary outcome measure(s)	1. Conversion rate: Collected retrospectively via a Case Report Form sent to the practice, to be completed by the practice manager or allocated staff member for the following intervals: The 12 months prior to randomisation, 2 to 14 months post randomisation 2. USC/2WW referral rate: Collected retrospectively via a Case Report Form sent to the practice, to be completed by the practice manager or allocated staff member for the following intervals: The 12 months prior to randomisation, 2 to 14 months post randomisation 3. Detection rate: Collected retrospectively via a Case Report Form sent to the practice, to be completed by the practice manager or allocated staff member for the following intervals: The 12 months prior to randomisation, 14 to 26 months post-randomisation 4. Cancer stage at diagnosis: Collected retrospectively by GP research staff or trained nurses using a Case Report Form for the following intervals: 14 to 26 months post-randomisation 5. Adherence to NICE NG12 guidelines (NICE, 2015): Guideline interval – the time between patient first meeting any criterion within the NICE NG12 guidelines for referral to diagnosis (Price et al., 2021) collected retrospectively by GP research staff or trained nurses using a Case Report form for the period 14 to 26 months post-randomisation. 6. Factors that contribute to longer Primary Care Intervals for patients diagnosed with cancer: qualitative measures plus subgroup analysis, case note review data collected in summarised form by GP research staff or trained nurses for the period 14 to 26 months post-randomisation. 7. Patient and carer experiences of urgent referral: qualitative measures collected via qualitative interviews with patients and carers; stakeholder interviews will take place between 3 and 6 months, interviews with patients and carers will take place from month 10 8. Mechanisms and contextual factors that drive the implementation of the intervention: practice characteristics and demographics collected at baseline via the practice questionnaire and at 12 months 9. Reach – the proportion of staff members within the practice that attended any of the workshops or had the workshop materials disseminated to them, collected during and after the workshops via workshop registration lists, the NoMAD survey and feedback forms 10. Recruitment – number of practices randomised collected throughout the study period via trial recruitment log 11. Dose – defined as the number of workshop sessions delivered to each practice, collected throughout the workshop delivery period via workshop completion lists 12. The acceptability of the intervention among practice teams: adherence to practice safety netting plan collected through the NoMAD questionnaire, which will be sent to participating practices 2 months post-workshop 13. Acceptability: feedback forms completed by participating staff members immediately following the workshop sessions, nomination of a safety netting champion NoMAD and workshop notes 14. Whether the ThinkCancer intervention results in increased safety netting, evidenced by NoMAD questionnaire responses, which will be sent to participating practices 2 months post-workshop 15. Cancer-related DATIX information: practice manager to provide cancer-related DATIX information for 2 to 14 months post-randomisation period
Completion date	30/06/2027

Eligibility

Participant type(s)	Health professional
Age group	Adult
Sex	All
Target sample size at registration	76
Total final enrolment	99
Key inclusion criteria	General practices will primarily be recruited from Wales, topped up with practices from North West of England. We will recruit 8-10 practices from each of the seven Health Boards in Wales, and 8-10 from North West England; this conservative estimate is informed by feasibility study recruitment. Wales and North West England have similar regional demography; with higher deprivation and cancer rates compared with other UK areas (NWCR, 2021b, 2021a). If recruitment is challenging, we propose to extend the study into South West England. Networks and contacts established through the feasibility study will be maintained in order to maximise recruitment across Wales, and regional Clinical Research Network (CRN) teams will assist in recruiting the practices across all of the centres.
Key exclusion criteria	All practice types will be included
Date of first enrolment	01/12/2023
Date of final enrolment	17/09/2024

Locations

Countries of recruitment

United Kingdom
England
Wales

Study participating centre

Bangor University

Wales - North Wales Centre for Primary Care Research
Cambrian 2
Wrexham Technology Park
Wrexham
LL13 7YP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and /or analysed during the current study will be available on request from Dr Nia Goulden (n.goulden@bangor.ac.uk)

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Control version 6	10/01/2023	27/01/2023	No	Yes
Participant information sheet	Intervention version 4	10/01/2023	27/01/2023	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version 0.91		27/01/2023	No	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Additional files

43125_PROTOCOL_V0.91.pdf: Protocol file
43125_PIS_control_V6_10Jan23.pdf: Control
43125_PIS_intervention_V4_10Jan23.pdf: Intervention

Editorial Notes

06/03/2025: The following changes were made to the trial record:
1. The ethics approval was added.
2. The overall end date was changed from 31/08/2026 to 30/06/2027.
3. The study website was added.
4. The total final enrolment was added.
5. The recruitment start date was changed from 01/03/2023 to 01/12/2023.
6. The recruitment end date was changed from 01/02/2024 to 17/09/2024.
27/01/2023: Trial's existence confirmed by Cancer Research Wales.