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.
Studie Overzicht
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Bangor, Verenigd Koninkrijk
- Werving
- Betsi Cadwaldr University Health Board
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Blaenau Gwent, Verenigd Koninkrijk
- Werving
- Aneurin Bevan University Health Board
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Camarthenshire, Verenigd Koninkrijk
- Werving
- Hywel Dda University Health Board
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Cardiff, Verenigd Koninkrijk
- Werving
- Cardiff and Vale University Health Board
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Cwm Taf, Verenigd Koninkrijk
- Werving
- Cwm Taf Morgannwg University Health Board
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Powys, Verenigd Koninkrijk
- Werving
- Powys Teaching Health Board
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Swansea, Verenigd Koninkrijk
- Werving
- Swansea Bay University Health Board
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Geen tussenkomst: Gebruikelijke praktijk
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Experimenteel: Intervention
Receives educational workshop
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Feasibility of a future definitive trial
Tijdsspanne: From date of initial expression of interest to participate to end of follow up period (13 months)
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Number of practices approached, interested in participating, consented and randomised, retention of recruited practices, ability to collect data
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From date of initial expression of interest to participate to end of follow up period (13 months)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Two Week Wait referral rate
Tijdsspanne: Six months pre-randomisation and six months post-randomisation
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Number of two week rate referrals made in a given time period, multiplied by 100000 and divided by the practice list size
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Six months pre-randomisation and six months post-randomisation
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Primary Care Interval
Tijdsspanne: Six months pre-randomisation and six months post-randomisation
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The time between the date of first presentation and the date of referral
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Six months pre-randomisation and six months post-randomisation
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Clare Wilkinson, Bangor University
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- UWalesBangor
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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