- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jessica L Roberts, BSc, PhD
- Número de teléfono: 01248 383516
- Correo electrónico: j.l.roberts@bangor.ac.uk
Copia de seguridad de contactos de estudio
- Nombre: Stefanie Disbeschl
- Número de teléfono: 01248 383507
- Correo electrónico: stefanie.disbeschl@bangor.ac.uk
Ubicaciones de estudio
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Bangor, Reino Unido
- Reclutamiento
- Betsi Cadwaldr University Health Board
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Blaenau Gwent, Reino Unido
- Reclutamiento
- Aneurin Bevan University Health Board
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Camarthenshire, Reino Unido
- Reclutamiento
- Hywel Dda University Health Board
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Cardiff, Reino Unido
- Reclutamiento
- Cardiff and Vale University Health Board
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Cwm Taf, Reino Unido
- Reclutamiento
- Cwm Taf Morgannwg University Health Board
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Powys, Reino Unido
- Reclutamiento
- Powys Teaching Health Board
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Swansea, Reino Unido
- Reclutamiento
- Swansea Bay University Health Board
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: Práctica habitual
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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Feasibility of a future definitive trial
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Two Week Wait referral rate
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Clare Wilkinson, Bangor University
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- UWalesBangor
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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