Remote Mindfulness Breathing Training for Patients Undergoing Chemotherapy
Effects of Remote Mindfulness Breathing Training on Symptom Distress, Fatigue and Psychological Well-Being in Patients Undergoing Chemotherapy
This randomized controlled trial will evaluate the effects of a mobile-delivered remote mindfulness breathing training program on symptom distress, fatigue, anxiety, and depression in adults with cancer who are receiving chemotherapy.
A total of 80 participants will be randomly assigned in a 1:1 ratio to either an intervention group or a control group. The intervention group will complete 5 to 10 minutes of guided mindfulness breathing practice each day for 3 weeks using a mobile-accessible video. The control group will receive usual care and one approximately 5-minute mindfulness breathing instruction session. Outcomes will be assessed at baseline and at the end of the 3-week intervention.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study is a prospective, two-arm, assessor-blinded randomized controlled trial involving adults with any type of cancer who are receiving chemotherapy in inpatient units or at the Tri-Service General Hospital breast surgery outpatient clinic.
After providing written informed consent and completing the baseline assessment, eligible participants will be randomly allocated by computer in a 1:1 ratio to the intervention group or the control group. The intervention group will receive a mobile-delivered remote mindfulness breathing training program and will be instructed to practice with a guided video for approximately 5 to 10 minutes daily for 3 weeks. The control group will receive usual care and one approximately 5-minute mindfulness breathing stress-reduction instruction session.
Study assessments will be conducted before the intervention and at the end of week 3. Symptom distress will be assessed using the National Comprehensive Cancer Network Distress Thermometer, fatigue using the Brief Fatigue Inventory, anxiety using the Generalized Anxiety Disorder-7, and depression using the Patient Health Questionnaire-9. To reduce measurement bias, the post-intervention assessment will be conducted by a research assistant who is unaware of the participants' group assignments.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Lei-Yu Chen
- Número de teléfono: 671419 +886-2-2764-2151
- Correo electrónico: leiyu841125@gmail.com
Ubicaciones de estudio
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Taipei City
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Taipei, Taipei City, Taiwán, 105
- Tri-Service General Hospital Songshan Branch
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Contacto:
- Lei-Yu Chen
- Número de teléfono: 671419 +886-2-2764-2151
- Correo electrónico: leiyu841125@gmail.com
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Taipei, Taipei City, Taiwán, 114
- Tri-Service General Hospital
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Contacto:
- Lei-Yu Chen
- Número de teléfono: 671419 +886-2-2764-2151
- Correo electrónico: leiyu841125@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Adults aged 20 years or older with full legal capacity. Diagnosed with any type of cancer and currently receiving chemotherapy as an inpatient or at the Tri-Service General Hospital breast surgery outpatient clinic.
Able to understand Chinese or Taiwanese and able to read and operate a smartphone or tablet.
Willing to participate in the study and accept random assignment. Have access to a personal mobile device capable of accessing the study materials.
Exclusion Criteria:
Severe psychiatric disorders, such as schizophrenia or bipolar disorder, or neurodegenerative diseases, such as moderate or severe dementia.
Clinical deterioration or poor prognosis requiring a change in treatment or transition to palliative or hospice care.
Concurrent participation in another psychological intervention study that may affect emotional outcomes.
Deemed unsuitable for breathing training or receiving prolonged sedation.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Mobile Remote Mindfulness Breathing Training
Participants will complete 5 to 10 minutes of guided mobile-delivered remote mindfulness breathing practice daily for 3 weeks, in addition to usual care.
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Participants will use a mobile-accessible guided video to practice mindfulness awareness combined with slow diaphragmatic breathing for approximately 5 to 10 minutes daily for 3 weeks during chemotherapy, in addition to usual care.
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Comparador activo: Brief Mindfulness Breathing Instruction
Participants will receive usual care and one approximately 5-minute mindfulness breathing stress-reduction instruction session.
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Participants will receive one approximately 5-minute mindfulness breathing stress-reduction instruction session in addition to usual care.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Distress Level Assessed by the NCCN Distress Thermometer
Periodo de tiempo: Baseline and Week 3
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The NCCN Distress Thermometer is a single-item self-report scale ranging from 0 (no distress) to 10 (extreme distress).
Higher scores indicate greater distress.
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Baseline and Week 3
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Change in Fatigue Assessed by the Brief Fatigue Inventory
Periodo de tiempo: Baseline and Week 3
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The Brief Fatigue Inventory contains 9 items rated from 0 to 10.
The global fatigue score is calculated as the mean of the completed items, with higher scores indicating greater fatigue severity and interference.
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Baseline and Week 3
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Change in Anxiety Assessed by the Generalized Anxiety Disorder-7
Periodo de tiempo: Baseline and Week 3
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The Generalized Anxiety Disorder-7 contains 7 items rated from 0 to 3, producing a total score ranging from 0 to 21.
Higher scores indicate greater anxiety severity.
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Baseline and Week 3
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Change in Depression Assessed by the Patient Health Questionnaire-9
Periodo de tiempo: Baseline and Week 3
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The Patient Health Questionnaire-9 contains 9 items rated from 0 to 3, producing a total score ranging from 0 to 27.
Higher scores indicate greater depressive symptom severity.
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Baseline and Week 3
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lei-Yu Chen, Tri-Service General Hospital (TSGH)
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
Otros números de identificación del estudio
- MB-2026-01
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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