- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07820436
Interactive Robot-Guided Exercise Program for Cancer-Related Fatigue
Using an Interactive Kebbi Robot to Develop an Exercise Program for Cancer-Related Fatigue: Assessing Its Effectiveness
The goal of this study is to learn whether an exercise program guided by an interactive robot can help reduce tiredness in people with cancer. This kind of tiredness, called cancer-related fatigue, is common during cancer treatment and can make everyday activities harder.
People who take part in the exercise program will do sessions guided by the robot. Before and after each session, the study team checks things like heart rate, breathing rate, and blood pressure, and asks about tiredness and other symptoms.
Family members and nurses who help patients use the robot are also asked to share their views on how well the robot's teaching materials hold their attention and help them feel confident and satisfied.
Everyone who joins the exercise part of the study receives the same robot-guided program. There is no separate group that skips the robot program.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Cancer-related fatigue is one of the most common and distressing symptoms experienced by patients undergoing cancer treatment, often persisting despite rest and negatively affecting daily function and quality of life. Exercise is a recommended non-pharmacological strategy to help manage this symptom, but adherence to conventional exercise programs among cancer patients is often limited.
This study develops and evaluates an exercise teaching program delivered through an interactive robot (Kebbi) for cancer patients treated at Taipei Medical University-affiliated Wanfang Hospital. The robot guides participants through a structured exercise routine. Physiological parameters (heart rate, respiratory rate, systolic and diastolic blood pressure) are recorded immediately before and after exercise sessions, and patient-reported fatigue and symptom burden are assessed repeatedly over the course of the intervention period.
In addition to the patient cohort, family caregivers and nursing staff who interact with the robot-based teaching materials are invited to evaluate the instructional design of the materials, focusing on their ability to engage attention, demonstrate relevance, build confidence, and achieve satisfaction.
This is a single-group study; all enrolled patients receive the robot-guided exercise program, and outcomes are compared within participants before versus after the intervention. No randomization or control group is used.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Taipei, Taiwán
- Wanfang Hospital
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age 20 years or older
- Confirmed diagnosis of cancer, currently receiving anticancer treatment at Taipei Municipal Wanfang Hospital
- Presence of cancer-related fatigue (self-reported or clinically assessed)
- Sufficient cognitive and physical function to participate in a robot-guided, low-to-moderate intensity exercise program
- Willing and able to provide informed consent
Exclusion Criteria:
- Severe cognitive impairment or communication barriers preventing comprehension of study instructions
- Unstable cardiopulmonary or hemodynamic status contraindicating exercise
- Bedridden or physical performance status precluding participation in basic exercise movements
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Robot-Guided Exercise Group
Cancer patients receiving the interactive robot (Kebbi)-guided exercise program.
Vital signs, fatigue, and symptom burden are assessed before and after sessions.
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A structured exercise program delivered and guided by an interactive robot (Kebbi), designed to help manage cancer-related fatigue.
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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 Cancer-Related Fatigue Severity
Periodo de tiempo: Baseline (prior to intervention) through completion of the intervention (up to 5 days), assessed up to three times daily during the intervention period
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Fatigue severity assessed using the Brief Fatigue Inventory (BFI), a self-reported measure with items rated from 0 (no fatigue) to 10 (fatigue as bad as you can imagine).
Higher scores indicate greater fatigue severity.
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Baseline (prior to intervention) through completion of the intervention (up to 5 days), assessed up to three times daily during the intervention period
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Symptom Burden
Periodo de tiempo: Baseline (prior to intervention) and immediately after completion of the intervention (up to 5 days)
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Symptom burden assessed using the Edmonton Symptom Assessment Scale (ESAS), which rates the severity of multiple symptoms (e.g., pain, tiredness, drowsiness, nausea, appetite) on a 0-10 scale.
Higher scores indicate greater symptom severity.
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Baseline (prior to intervention) and immediately after completion of the intervention (up to 5 days)
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Change in Heart Rate
Periodo de tiempo: Immediately before and immediately after each exercise session, up to 4 sessions within the 5-day intervention period
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Heart rate (beats per minute) measured immediately before and immediately after each exercise session.
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Immediately before and immediately after each exercise session, up to 4 sessions within the 5-day intervention period
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Change in Respiratory Rate
Periodo de tiempo: Immediately before and immediately after each exercise session, up to 4 sessions within the 5-day intervention period
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Respiratory rate (breaths per minute) measured immediately before and immediately after each exercise session.
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Immediately before and immediately after each exercise session, up to 4 sessions within the 5-day intervention period
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Change in Systolic Blood Pressure
Periodo de tiempo: Immediately before and immediately after each exercise session, up to 4 sessions within the 5-day intervention period
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Systolic blood pressure (mmHg) measured immediately before and immediately after each exercise session.
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Immediately before and immediately after each exercise session, up to 4 sessions within the 5-day intervention period
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Change in Diastolic Blood Pressure
Periodo de tiempo: Immediately before and immediately after each exercise session, up to 4 sessions within the 5-day intervention period
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Diastolic blood pressure (mmHg) measured immediately before and immediately after each exercise session.
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Immediately before and immediately after each exercise session, up to 4 sessions within the 5-day intervention period
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Colaboradores e Investigadores
Patrocinador
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
- ROBOT_education_N202407020
- TMU-JIRB (Otro identificador: TMU-JIRB)
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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