Standard Medical Care or Urgent Chest X-ray in Diagnosing Lung Cancer in Smokers With Chest Symptoms Who Are Older Than 60 Years
23 de agosto de 2013 actualizado por: Wales Cancer Trials Unit
A Pilot Clinical Trial Looking at the Effect on Lung Cancer Diagnosis of Giving a CXR to Smokers Aged Over 60 With Chest Symptoms
RATIONALE: Diagnostic procedures, such as an urgent chest x-ray, may help in planning cancer treatment. It is not yet known whether standard medical care is more effective than an urgent x-ray in diagnosing lung cancer in smokers with chest symptoms who are older than 60 years.
PURPOSE: This randomized clinical trial is studying standard medical care to see how well it works compared with an urgent chest x-ray in diagnosing lung cancer in smokers with chest symptoms who are older than 60 years.
Descripción general del estudio
Estado
Estado
Desconocido
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
Primary
- To determine the prevalence of extra-NICE symptoms in patients consulting in UK general practice.
- To determine the proportion of patients who agree to participate in the trial.
- To determine the proportion of patients who are diagnosed with lung cancer and the best sources of routine data for capturing lung cancers.
Secondary
- To determine the best way to train general practitioners to identify and recruit eligible patients into the trial.
- To determine the most effective method of presenting the trial (and randomization) to patients.
- To determine the barriers to recruitment and how to overcome those barriers.
- To determine the best tools to use to measure anxiety/depression that may be caused by unnecessary chest-x-rays or no chest x-rays.
- To determine the best measures of resource use to facilitate health economic analysis of the cost-effectiveness of 'extra-NICE'.
- To determine the stage at diagnosis, performance status, and the proportion of patients receiving radical treatments in those diagnosed with lung cancer.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm A: Patients are managed as per the National Institute for Health and Clinical Excellence (NICE) guidelines.
- Arm B: Patients are referred for an urgent chest x-ray according to extra-NICE guidelines.
General practitioners from South East Wales are surveyed to assess their level of interest in the proposed full trial. For the feasibility study, 20 South East Wales general practices and 6 South Yorkshire general practices are selected. General practitioners are trained to recruit all patients who fulfill the extra-NICE criteria as well as those who do not.
Patients complete questionnaires (HADS, EQ-5D, and ICECAP[O]) at baseline and at 2 months to measure quality of life and health economic analysis of the cost-effectiveness of extra-NICE guidelines.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Tipo de estudio
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
Inscripción
386
Fase
Fase
- No aplica
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
60 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
DISEASE CHARACTERISTICS:
- Patients over 60 seeing a participating General Practitioner
Currently smokes 10 or more pack years, meeting at least one of the following criteria:
- New or altered cough of any duration reported to primary care
- Increased breathlessness or wheezing (with or without purulent sputum)
Do not qualify for an urgent referral for a chest x-ray under the National Institute for Health and Clinical Excellence (NICE) guidelines (i.e., hemoptysis or unexplained or persistent [lasting > 3 weeks] signs or symptoms), including having any of the following:
- Cough
- Chest/shoulder pain
- Dyspnea
- Weight loss
- Chest signs
- Hoarseness
- Finger clubbing
- Features suggestive of metastasis from a lung cancer (e.g., in the brain, bone, liver, or skin)
- Cervical/supraclavicular lymphadenopathy
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- No chest x-ray within in past 3 months
- No need for a chest x-ray within the next 3 weeks for reasons other than those listed under Disease Characteristics
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Enmascaramiento: Ninguno (etiqueta abierta)
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
|---|
|
Prevalence of extra-NICE symptoms in patients consulting in UK general practice
|
|
Proportion of patients who agree to participate in the trial
|
|
Proportion of patients who are diagnosed with lung cancer and the best sources of routine data for capturing lung cancers
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
|---|
|
Best way to train general practitioners to identify and recruit eligible patients into the trial
|
|
Most effective method of presenting the trial (and randomization) to patients
|
|
Barriers to recruitment and how to overcome those barriers
|
|
Best tools to use to measure anxiety/depression that may be caused by unnecessary chest-x-rays or no chest x-rays
|
|
Best measures of resource use to facilitate health economic analysis of the cost-effectiveness of 'extra-NICE'
|
|
Stage at diagnosis, performance status, and the proportion of patients receiving radical treatments in those diagnosed with lung cancer
|
|
False-positive and false-negative rates for chest x-rays
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Richard Neal, MD, North Wales Clinical School
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Prout H, Tod A, Neal R, Nelson A. Maximising recruitment of research participants into a general practice based randomised controlled trial concerning lung diagnosis-staff insights from an embedded qualitative study. Trials. 2022 Mar 21;23(1):225. doi: 10.1186/s13063-022-06125-y.
- Prout HC, Barham A, Bongard E, Tudor-Edwards R, Griffiths G, Hamilton W, Harrop E, Hood K, Hurt CN, Nelson R, Porter C, Roberts K, Rogers T, Thomas-Jones E, Tod A, Yeo ST, Neal RD, Nelson A. Patient understanding and acceptability of an early lung cancer diagnosis trial: a qualitative study. Trials. 2018 Aug 4;19(1):419. doi: 10.1186/s13063-018-2803-4.
- Neal RD, Barham A, Bongard E, Edwards RT, Fitzgibbon J, Griffiths G, Hamilton W, Hood K, Nelson A, Parker D, Porter C, Prout H, Roberts K, Rogers T, Thomas-Jones E, Tod A, Yeo ST, Hurt CN. Immediate chest X-ray for patients at risk of lung cancer presenting in primary care: randomised controlled feasibility trial. Br J Cancer. 2017 Jan;116(3):293-302. doi: 10.1038/bjc.2016.414. Epub 2017 Jan 10.
- Hurt CN, Roberts K, Rogers TK, Griffiths GO, Hood K, Prout H, Nelson A, Fitzgibbon J, Barham A, Thomas-Jones E, Edwards RT, Yeo ST, Hamilton W, Tod A, Neal RD. A feasibility study examining the effect on lung cancer diagnosis of offering a chest X-ray to higher-risk patients with chest symptoms: protocol for a randomized controlled trial. Trials. 2013 Nov 26;14:405. doi: 10.1186/1745-6215-14-405.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
Inicio del estudio
1 de junio de 2011
Finalización primaria (Anticipado)
Finalización primaria
1 de junio de 2013
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
27 de abril de 2011
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
27 de abril de 2011
Publicado por primera vez (Estimar)
Publicado por primera vez
28 de abril de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización publicada
26 de agosto de 2013
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
23 de agosto de 2013
Última verificación
Última verificación
1 de abril de 2011
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- CDR0000699222
- WCTU-EL-CID
- EU-21112
- CRUK-C8350/A12199
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