- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Bangor, Storbritannia
- Rekruttering
- Betsi Cadwaldr University Health Board
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Blaenau Gwent, Storbritannia
- Rekruttering
- Aneurin Bevan University Health Board
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Camarthenshire, Storbritannia
- Rekruttering
- Hywel Dda University Health Board
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Cardiff, Storbritannia
- Rekruttering
- Cardiff and Vale University Health Board
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Cwm Taf, Storbritannia
- Rekruttering
- Cwm Taf Morgannwg University Health board
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Powys, Storbritannia
- Rekruttering
- Powys Teaching Health Board
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Swansea, Storbritannia
- Rekruttering
- Swansea Bay University Health Board
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Ingen inngripen: Vanlig praksis
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Feasibility of a future definitive trial
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Two Week Wait referral rate
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Clare Wilkinson, Bangor University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- UWalesBangor
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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Kliniske studier på ThinkCancer workshop
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University of SurreyFullført
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Shiraz University of Medical SciencesShiraz education development centerFullført
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LiquidGoldConceptJohns Hopkins University; University of Michigan; Michigan State UniversityFullførtAmming | PasientsimuleringForente stater
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McMaster UniversitySocial Sciences and Humanities Research Council of CanadaFullførtSosial isoleringCanada
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University of Erlangen-Nürnberg Medical SchoolGerman Federal Ministry of Education and Research; University of Erlangen-NürnbergUkjentRyggsmerte | KommunikasjonTyskland
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University of California, San FranciscoUniversity of California, Berkeley; National Institute of Environmental... og andre samarbeidspartnereRekrutteringRisikoreduksjon | Bare barn | MiljøeksponeringForente stater
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University of HoustonFullførtPsykiske lidelser | Traume | Posttraumatisk stresslidelse | Tankefullhet | BrannmennForente stater
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University of AlbertaAlberta Innovates Health SolutionsFullført
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Tel-Aviv Sourasky Medical CenterDuke UniversityUkjentFortvilelse blant kreftpasienter og onkologerForente stater, Israel
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Fundació Institut de Recerca de l'Hospital de la...FullførtAldersrelaterte hukommelsesforstyrrelser | MinnetapSpania