- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04823559
The ThinkCancer! Feasibility Study
The ThinkCancer! Intervention: Protocol for a Feasibility Study Incorporating a Randomised Pilot Trial With an Embedded Process and Economic Evaluation
Background Wales, like other UK countries, has relatively poor cancer outcomes. Late diagnosis and a slow referral process are major contributors. General practitioners (GPs) and other care providers working in primary care 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. The ThinkCancer! Workshop is an educational behaviour change intervention aimed at the whole general medical practice team, designed to improve primary care approaches to ensure timely diagnosis of cancer. The workshop will consist of teaching and awareness sessions, appointment of a Safety Netting Champion and the development of a bespoke Safety Netting Plan. This study aims to assess the feasibility of the ThinkCancer! Intervention for a future definitive randomised controlled trial, in terms of recruitment, randomisation, retention, acceptability, adherence and barriers to the intervention.
Methods The ThinkCancer! study is a randomised, multisite feasibility trial, with an embedded process evaluation and economic evaluation. Twenty-three to 30 general medical 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 Interval (PCI), Two Week Wait (2WW) referral rate, conversion rate and detection rate at baseline and six months post-randomisation. Participant feedback, researcher reflective notes 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 feasibility study will inform the future design of a full-scale definitive phase III trial.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jessica L Roberts, BSc, PhD
- Phone Number: 01248 383516
- Email: j.l.roberts@bangor.ac.uk
Study Contact Backup
- Name: Stefanie Disbeschl
- Phone Number: 01248 383507
- Email: stefanie.disbeschl@bangor.ac.uk
Study Locations
-
-
-
Bangor, United Kingdom
- Recruiting
- Betsi Cadwaldr University Health Board
-
Blaenau Gwent, United Kingdom
- Recruiting
- Aneurin Bevan University Health Board
-
Camarthenshire, United Kingdom
- Recruiting
- Hywel Dda University Health Board
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Cardiff, United Kingdom
- Recruiting
- Cardiff and Vale University Health Board
-
Cwm Taf, United Kingdom
- Recruiting
- Cwm Taf Morgannwg University Health Board
-
Powys, United Kingdom
- Recruiting
- Powys Teaching Health Board
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Swansea, United Kingdom
- Recruiting
- Swansea Bay University Health Board
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Any practices in Wales are eligible for inclusion.
Exclusion Criteria:
- As we intend to include a broad group of general medical practices, there are no formal exclusion criteria.
As determining feasibility is the main objective of this study, the eligibility criteria remain broad in order to allow for inclusion of a range of practices, which will aid the intervention refinement and allow for a better understanding on what is feasible in all types of practices and why some practices may not take part.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual practice
|
|
Experimental: Intervention
Receives educational workshop
|
The proposed intervention, the ThinkCancer!
Workshop, is practice-based and consists of themed sessions for both clinical and non-clinical staff, the co-production of a Cancer Safety Netting Plan (CSNP) and the appointment of a Cancer Safety Netting Champion (CSNC).
The workshop aims to raise awareness and increase knowledge around current cancer diagnosis guidance and will be delivered over half a day during GP protected time in the form of face-to-face educational sessions.
Sessions will consist of a series of interactive activities exploring existing processes within practices and developing plans for change to implement each component.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of a future definitive trial
Time Frame: From date of initial expression of interest to participate to end of follow up period (13 months)
|
Number of practices approached, interested in participating, consented and randomised, retention of recruited practices, ability to collect data
|
From date of initial expression of interest to participate to end of follow up period (13 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Two Week Wait referral rate
Time Frame: Six months pre-randomisation and six months post-randomisation
|
Number of two week rate referrals made in a given time period, multiplied by 100000 and divided by the practice list size
|
Six months pre-randomisation and six months post-randomisation
|
Primary Care Interval
Time Frame: Six months pre-randomisation and six months post-randomisation
|
The time between the date of first presentation and the date of referral
|
Six months pre-randomisation and six months post-randomisation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Clare Wilkinson, Bangor University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UWalesBangor
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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