Virtual Environments in Patients Receiving Treatment for Cancer (VE)
17 de julio de 2020 actualizado por: Dr. Andreas Charalambous, Cyprus University of Technology
The Effectiveness of Virtual Environment on the Adverse Psychological Effects in Patients Receiving Treatment for Cancer
The mood disturbances that lung cancer patients experience during and after chemotherapy have a debilitating effect on their quality of life.
The goal of the proposed project is to develop and test an intervention that relies on the use of immersive Virtual Reality (VR) to combat the adverse psychological/emotional consequences of receiving treatment for cancer.
Although VR has been used with success to treat various psychological conditions (e.g., phobias, PTSD), its potential in helping cancer patients experience an improved mood and hence better quality of life has not yet been tested.
In this project the investigators will first develop the virtual content (e.g., natural scenes) that patients will experience within a Head-Mounted-Display, simulating movement by manipulating a gesture controller.
The investigators will then carry out a randomized, double blind, crossover trial with 50 hospitalized cancer patients to test whether they can benefit psychologically and emotionally from their interaction with an immersive environment compared to those who will experience a guided imagery intervention.
A positive result will open the route for the future development of affordable self-administered VR solutions for treating the psychological side-effects of cancer treatment.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Although VR has been used with success to treat various psychological conditions (e.g., phobias, PTSD), its potential in helping cancer patients experience an improved mood and hence better quality of life has not yet been tested.
In this project the investigators will first develop the virtual content (e.g., natural scenes) that patients will experience within a Head-Mounted-Display, simulating movement by manipulating a gesture controller.
The investigators will then carry out a randomized, double blind, crossover trial with 50 hospitalized cancer patients to test whether they can benefit psychologically and emotionally from their interaction with an immersive environment compared to those who will experience a guided imagery intervention.
A positive result will open the route for the future development of affordable self-administered VR solutions for treating the psychological side-effects of cancer treatment.
Tipo de estudio
Intervencionista
Inscripción (Actual)
50
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
-
Nicosia, Chipre, 2047
- American Medical Centre
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-
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
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Patients will be included if they had a histopathological diagnosis of cancer (different types are allowed)
- were 18 years or older, on active treatment and were receiving care at the hospital as inpatients
- Eligible participants will need to be able to speak and understand Greek and they had given written informed consent
- Participants should also have a score of >60 on the POMS total mood disturbance scale, a >50 on the Karnofsky Performance Scale Index
- a mean of >50 on the Attentional Function Index (AFI)
Exclusion Criteria:
- Patients were excluded if they were receiving palliative care
- they had an impaired cognitive ability or
- they had an impaired visual ability
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: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervention VE
Session of Immersive Virtual Reality (VR) and Session of Guided Imagery
|
Patients in this group will experience the virtual content (e.g., natural scenes) through a Head-Mounted-Display, simulating movement by manipulating a gesture controller.
Following a resting period the patients will then experience the guided imagery session (e.g.
visual images of pleasant scenery)
Patients in this group will experience the guided imagery (e.g.
visual images of pleasant scenery).
Following a resting period the patients will then experience the virtual content (e.g., natural scenes) through a Head-Mounted-Display, simulating movement by manipulating a gesture controller
|
|
Comparador activo: Intervention GI
Session of Immersive Virtual Reality (VR) and Session of Guided Imagery
|
Patients in this group will experience the virtual content (e.g., natural scenes) through a Head-Mounted-Display, simulating movement by manipulating a gesture controller.
Following a resting period the patients will then experience the guided imagery session (e.g.
visual images of pleasant scenery)
Patients in this group will experience the guided imagery (e.g.
visual images of pleasant scenery).
Following a resting period the patients will then experience the virtual content (e.g., natural scenes) through a Head-Mounted-Display, simulating movement by manipulating a gesture controller
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes in Mood Disturbances as measured by the POMS
Periodo de tiempo: Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days
|
The POMS total mood disturbance comprises subscales that evaluate anxiety, depression, anger, vigor, fatigue, and confusion.
The possible range of scores for the TMDS is -40 through 192 with higher scores indicating greater mood.
Lower scores indicate an improvement in mood
|
Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes in Quality of Life as measured by FACT-G
Periodo de tiempo: Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days
|
FACT-G, is a self-report instrument consisting of 27-items
|
Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days
|
|
Changes in Blood Pressure
Periodo de tiempo: Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days
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Measurement of Blood Pressure
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Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days
|
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Changes in Heart Rate
Periodo de tiempo: Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days
|
Measurement of Heart Rate
|
Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Andreas Charalambous, andreas.charalambous@cut.ac.cy
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.
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 (Actual)
5 de febrero de 2018
Finalización primaria (Actual)
1 de enero de 2020
Finalización del estudio (Actual)
20 de enero de 2020
Fechas de registro del estudio
Enviado por primera vez
6 de marzo de 2015
Primero enviado que cumplió con los criterios de control de calidad
13 de marzo de 2015
Publicado por primera vez (Estimar)
19 de marzo de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de julio de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
17 de julio de 2020
Última verificación
1 de julio de 2020
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- AC-VES-91
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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