Patients' Expectations About the Survival Benefits of Cancer Drugs Approved Based on Progression-Free Survival
Patients' Expectations About the Survival Benefits of Cancer Drugs Approved Based on Progression-Free Survival: a Randomized Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
- Otro: FDA explanation for progression-free survival (control)
- Otro: FDA explanation for progression-free survival with overall survival data
- Otro: NCI explanation for progression-free survival
- Otro: NCI explanation for progression-free survival with overall survival data
- Otro: Plain-language explanation of progression-free survival
- Otro: Plain-language explanation of progression-free survival with overall survival data
Descripción detallada
Progression-free survival (PFS) (the time until a tumour grows, spreads, or the patient dies) is among the most common outcomes supporting the approval of new cancer drugs. Likely owing to similar terminology and the use of the word 'survival', patients often confuse PFS with overall survival, which may lead to treatment decisions that are not aligned with patients' individual preferences. Alternative descriptions of PFS that acknowledge the absence of a survival benefit may improve understanding.
This randomized controlled trial will evaluate whether communicating data on overall survival data in addition to information on progression-free improves the accuracy of cancer patients' expectations about the survival benefits of new cancer drugs, since patients may only understand the distinction between these outcomes when they are presented with data on both. Three alternative descriptions for PFS will be compared, including those used by the FDA, the National Cancer Institute, and a plain-language version that was developed drawing on prior work about communicating PFS. This study will also compare the additive effect of overall survival data for each alternative description of PFS.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Avi Cherla
- Número de teléfono: 020 7955 7975
- Correo electrónico: avi_cherla@hphci.harvard.edu
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Harvard Medical School and Harvard Pilgrim Health Care Institute
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Contacto:
- Avi Cherla
- Número de teléfono: 020 7852 3727
- Correo electrónico: avi_cherla@hphci.harvard.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- US adults with a current or former cancer diagnosis (excluding nonmelanoma skin cancer)
- US adults 18 years of age and older, fluent in English, and residing in the United States.
Exclusion Criteria:
- Adults who do not have a former cancer diagnosis or who were diagnosed with nonmelanoma skin cancer; adults who complete the survey in under 150 seconds, and who do not meet the other inclusion criteria.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador de placebos: FDA explanation for progression-free survival (control)
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Progression-free survival
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Experimental: FDA explanation for progression-free survival with overall survival data
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The description, 'progression-free survival', along with data on overall survival.
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Experimental: NCI explanation for progression-free survival
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The description, 'the length of time during and after treatment that a patient lived with the cancer but it did not get worse'.
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Experimental: NCI explanation for progression-free survival with overall survival data
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The description, 'the length of time during and after treatment that a patient lived with the cancer but it did not get worse', along with data on overall survival.
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Experimental: Plain-language explanation of progression-free survival
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The description, 'the length of time until a test showed the cancer grew, spread, or worsened'.
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Experimental: Plain-language explanation of progression-free survival with overall survival data
|
The description, 'the length of time until a test showed the cancer grew, spread, or worsened', along with data on overall survival.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Accuracy of expectations about the survival benefits of a new cancer drug approved based on progression-free survival
Periodo de tiempo: Assessed immediately after the intervention
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Compared to standard treatment, do patients with advanced kidney cancer live longer when treated with Velotrex? - Response options: definitely yes, probably yes, probably no, definitely no |
Assessed immediately after the intervention
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Perceptions of drug benefits and risks
Periodo de tiempo: Assessed immediately after the intervention
|
How would you describe the benefits of Velotrex? - Very large, large, moderate, small, very small to none Do you think the benefits of Velotrex outweigh the side effects? - Response options: definitely yes, probably yes, probably no, definitely no Which treatment would you recommend to a patient with kidney cancer - Response options: Velotrex, standard treatment |
Assessed immediately after the intervention
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias
- Administración de Servicios de Salud
- Calidad, acceso y evaluación de la atención médica
- Técnicas de investigación
- Métodos epidemiológicos
- Diagnóstico
- Mecanismos de evaluación de atención médica
- Calidad de la atención médica
- Salud pública
- Medio ambiente y salud pública
- Evaluación de resultados, atención médica
- Evaluación de resultados y procesos, atención médica
- Estadísticas como tema
- Pronóstico
- Resultado del Tratamiento
- Análisis de Supervivencia
- Supervivencia Libre de Progresión
Otros números de identificación del estudio
- 714377A
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.
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