- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04184557
Effectiveness of a Mindfulness Smartphone App to Reduce Emotional Distress in People With Cancer Waiting for Surgery
Effectiveness of a Mindfulness Smartphone App ("Staying Calm in the OR") to Reduce Distress in People With Cancer Waiting for Surgery: A Randomized Controlled Trial
Lung cancer and colorectal cancer accounted for the highest number of cancer deceases in 2016. Incidence is around 3.500 cases per year and patients are more commonly men (56%) aged around 69. This study focuses on people with a recent diagnosis of cancer who have been scheduled for surgery.
Evidence suggests that around 11% of people with cancer suffer from anxiety or adjustment disorders and 6,5% hold a diagnosis of major depressive disorder. Moreover, the perioperative period is the most distressing phase of the illness. However, a high number of patients do not have access to mental health services due to either limited resources and geographical limitations or the fear of being stigmatized. The aim is to explore the effectiveness of a mindfulness-based intervention for smartphones designed to reduce pre-surgical distress. It was conceived as a medical tool of prevention), with the purpose of diminishing emotional suffering and clinical complications after surgery. In 2020 Internet will be the most developed technology and almost everyone will have a smartphone; hence, an app for stress reduction will fit in this growing field.
Mindfulness is defined as the ability to pay attention to the present moment with a curious, non-judgmental attitude. Its training consists of both formal meditation practices and informal daily exercises. Mindfulness-based interventions are growing in our National Health System and rigorous researches are being conducted exhibiting good results regarding its effectiveness. However, the fact that Mindfulness instructors must be highly qualified makes these kinds of interventions exceedingly costly to implement. This team is experienced with mindfulness and has developed the app "En Calma en el Quirófano" ("Staying Calm in the OR") to reduce distress before surgery. It consists of a free, accessible, on-demand, short training through a series of guided meditation practices.
In this randomized controlled trial, participants are assigned either to the experimental ("Staying Calm in the OR") or the control arm (treatment as usual). The investigators expect anxiety and depression to be lower in the experimental arm; in addition, the researchers expect that "Staying Calm in the OR" participants will show higher levels of post-surgery recovery.
Descripción general del estudio
Descripción detallada
Lung cancer and colorectal cancer accounted for the highest number of cancer deceases in 2016. Incidence is around 3.500 cases per year and patients are more commonly men (56%) aged around 69. This study focuses on people with a recent diagnosis of cancer who have been scheduled for surgery.
Evidence suggests that around 11% of people with cancer suffer from anxiety or adjustment disorders and 6,5% hold a diagnosis of major depressive disorder. Moreover, the perioperative period is the most distressing phase of the illness. However, a high number of patients do not have access to mental health services due to either limited resources and geographical limitations or the fear of being stigmatized. The aim is to explore the effectiveness of a mindfulness-based intervention for smartphones designed to reduce pre-surgical distress. It was conceived as a medical tool of prevention), with the purpose of diminishing emotional suffering and clinical complications after surgery. In 2020 Internet will be the most developed technology and almost everyone will have a smartphone; hence, an app for stress reduction will fit in this growing field.
Mindfulness is defined as the ability to pay attention to the present moment with a curious, non-judgmental attitude. Its training consists of both formal meditation practices and informal daily exercises. Mindfulness-based interventions are growing in our National Health System and rigorous researches are being conducted exhibiting good results regarding its effectiveness. However, the fact that Mindfulness instructors must be highly qualified makes these kinds of interventions exceedingly costly to implement. This team is experienced with mindfulness and has developed the app "En Calma en el Quirófano" ("Staying Calm in the OR") to reduce distress before surgery. It consists of a free, accessible, on-demand, short training through a series of guided meditation practices.
In this randomized controlled trial, participants are assigned either to the experimental ("Staying Calm in the OR") or the control arm (treatment as usual). The investigators expect anxiety and depression to be lower in the experimental arm; in addition, the researchers expect that EnCalma participants will show higher levels of post-surgery recovery.
Main hypothesis. Anxiety and depression symptoms will be significantly lower in the experimental arm after Staying Calm in the OR" training.
Secondary hypotheses. Recovery after surgery will be higher amongst participants in the experimental arm, who will exhibit fewer post-surgical complications, lower rates of hospitalizations, lower levels of analgesia, shorter hospitalizations and a better quality of life.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Madrid, España, 28045
- La Paz University Hospital
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Madrid, España, 28041
- 12 Octubre University Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 18 - 100 years old
- Diagnosis of cancer
- Being in waitlist for surgery for less than 14 days
- Signed informed consent
Exclusion Criteria:
- Acute severe mental disorder according to DSM-5 diagnostic criteria
- Not having a smartphone
- Not being able to download and use the smartphone app "Calm before Surgery"
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: App "Staying Calm in the OR"
"Staying Calm in the OR" is a mindfulness-based stress-reduction smartphone tailored for people who are waiting for surgery.
It consists of a free, accessible, on-demand, short training through a series of guided meditation practices.
They are based on widely studied mindfulness-based programs, such as Mindfulness-Based Stress Reduction (MBSR) or Mindfulness Self Compassion (MSC).
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"Staying Calm in the OR" is a mindfulness-based stress-reduction smartphone tailored for people who are waiting for surgery.
It consists of a free, accessible, on-demand, short training through a series of guided meditation practices.
They are based on widely studied mindfulness-based programs, such as Mindfulness-Based Stress Reduction (MBSR) ir Mindfulness Self Compassion (MSC).
Otros nombres:
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Sin intervención: Treatment as Usual (TAU)
Participants assigned to Treatment As Usual (TAU) arm will not download the app until the study is completed.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in anxiety and depression
Periodo de tiempo: From baseline (15 days before surgery) to hospital discharge (around 7 days after surgery)
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Change in Hospital Anxiety and Depression Scale (HADS).
Anxiety and depressive symptoms are measured with this self-reported instrument.
The scores of the 15 items range from 0 to 4. The final score is the summatory of these items and range from 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
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From baseline (15 days before surgery) to hospital discharge (around 7 days after surgery)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in quality of life
Periodo de tiempo: From baseline (15 days before surgery) to hospital discharge (around 7 days after surgery)
|
Change in World Health Organization Quality of Life Brief Scale (WHOQOL-BREF).
This is a self-reported instrument that how much the person is satisfied with many aspects of his or her live, and general domains of the quality of life construct.
There are 26 items and each one is scored from 0 to 5. Higher scores suggest better quality of life in direct items and poorer quality of life in reverse items.
The final score range from 0 to 130, and the higher the score the better the perceived quality of life.
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From baseline (15 days before surgery) to hospital discharge (around 7 days after surgery)
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Change in pain experience
Periodo de tiempo: From baseline (15 days before surgery) to hospital discharge (around 7 days after surgery)
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Change in Visual Analog Scale (VAS) for pain.
In this visual scale, the evaluator needs to rate how much pain is he or she experiencing in the present moment.
Scores range from 0 (no pain at all) to 10 (extreme pain).
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From baseline (15 days before surgery) to hospital discharge (around 7 days after surgery)
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Presence of post-surgery complications
Periodo de tiempo: Clavien-Dindo Scale score at hospital discharge (around 7 days after surgery)
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Clavien-Dindo Scale score. This scale measures complications in surgery. They evaluator has to choose among the following categories: Grade I. Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. This grade also includes wound infections opened at the bedside. Grade II. Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition also included. Grade III. Requiring surgical, endoscopic or radiological intervention
Grade IV. Life-threatening complication (including CNS complications) requiring IC/ICU-management
Grade V Death of a patient |
Clavien-Dindo Scale score at hospital discharge (around 7 days after surgery)
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Change in blood pressure
Periodo de tiempo: From surgery to hospital discharge (around 7 days after surgery)
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Change in blood pressure, as registered by nursers during the hospitalization period
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From surgery to hospital discharge (around 7 days after surgery)
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Change in oxygen saturation
Periodo de tiempo: From surgery to hospital discharge (around 7 days after surgery)
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Change in oxygen saturation, as registered by nursers during the hospitalization period
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From surgery to hospital discharge (around 7 days after surgery)
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Change in temperature
Periodo de tiempo: From surgery to hospital discharge (around 7 days after surgery)
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Change in temperature, as registered by nursers during the hospitalization period
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From surgery to hospital discharge (around 7 days after surgery)
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Change in analgesia
Periodo de tiempo: From surgery to hospital discharge (around 7 days after surgery)
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Change in analgesia, as registered by nursers during the hospitalization period
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From surgery to hospital discharge (around 7 days after surgery)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Level of satisfaction with "Calm Before Surgery"
Periodo de tiempo: Hospital discharge (around 7 days after surgery)
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Level of satisfaction with smartphone app "Calm Before Surgery" measured by Client Satisfaction Questionnaire (CSQ-8).
This 8-item instrument explores how much a person is satisfied with different domains of healthcare services.
A final score between 8 and 32 is provided, with higher values indicating higher levels of satisfaction.
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Hospital discharge (around 7 days after surgery)
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Colaboradores e Investigadores
Investigadores
- Investigador principal: Beatriz Rodríguez-Vega, PhD, La Paz University Hospital; Madrid Autonomous University
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- EC-CS
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- RSC
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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