AI-Assisted Remote Monitoring for Patients With or at Risk of Malignant Bowel Obstruction
A Pragmatic Phase II Randomized Clinical Trial of Remote Monitoring for Patients With or at Risk of Malignant Bowel Obstruction (MBO)
The goal of this clinical trial is to learn whether artificial intelligence (AI)-assisted remote symptom monitoring can reduce hospital admissions related to malignant bowel obstruction (MBO) in patients with advanced cancer who have MBO or are at risk of developing MBO.
The main questions it aims to answer are:
- Does AI-assisted remote symptom monitoring reduce the proportion of patients who experience at least one hospital admission due to MBO within 90 days?
- Does AI-assisted remote symptom monitoring improve patient-reported outcomes, quality of life, healthcare resource utilization, and survival outcomes compared with standard care? Researchers will compare AI-assisted remote symptom monitoring plus standard care with standard care alone to determine whether remote monitoring can reduce MBO-related hospital admissions and improve patient outcomes.
Participants will receive study-specific assessments and follow-up for at least 90 days. Participants in the monitoring group will receive regular automated symptom-monitoring calls, and optional stool samples may be collected for microbiome research
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a prospective, pragmatic, randomized phase II clinical trial evaluating AI-assisted remote symptom monitoring in patients with advanced cancer who have MBO managed in the outpatient setting or are at risk of developing MBO. All participants will receive standard clinical management according to local standard of care, as well as educational materials regarding MBO, symptoms requiring medical attention, symptom management recommendations, and dietary advice.
Eligible participants will be identified using the Princess Margaret Malignant Bowel Obstruction (PMMBO) risk stratification system. Patients classified as yellow (at risk of MBO) or orange (outpatient MBO) will be eligible for the study. Participants who meet the eligibility criteria will be randomized in a 1:1 ratio to either the AI-assisted remote monitoring arm or the standard-of-care arm. Randomization will be stratified by previous MBO-related hospital admission (yes/no), baseline PMMBO risk category (yellow/orange), and study site.
This study consists of two study arms:
- Standard-of-Care Arm: Participants randomized to this arm will receive routine clinical follow-up and management according to local institutional practice.
- AI-Assisted Remote Monitoring Arm: Participants randomized to this arm will receive standard care plus remote symptom monitoring through an AI-based conversational platform. The platform will perform structured symptom assessments through automated telephone calls using a predefined questionnaire focused on MBO-related symptoms. Monitoring will be performed at least once per week and may be increased according to patient symptoms and clinical needs. Participant responses will be assessed in real time and predefined alerts will be displayed through a nursing dashboard, allowing healthcare professionals to review symptoms and initiate clinical interventions when considered necessary.
A total of 140 participants will be enrolled and randomized, with 70 participants assigned to each study arm. Participants will undergo baseline and follow-up assessments according to the study schedule and will be followed for at least 90 days after randomization. Monitoring in the intervention arm may continue beyond Day 90, if clinically indicated, for a maximum duration of 12 months.
The estimated recruitment period is 24 months
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ainhoa Madariaga Urrutia
- Número de teléfono: +34645719358
- Correo electrónico: ainhoa.madariaga@salud.madrid.org
Copia de seguridad de contactos de estudio
- Nombre: Daniel Fernández Villa
- Número de teléfono: 454637 +34917792637
- Correo electrónico: danielfvilla.imas12@h12o.es
Ubicaciones de estudio
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Madrid, España, 28041
- Hospital Universitario 12 de Octubre
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Madrid
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Majadahonda, Madrid, España, 28041
- Hospital Universitario Puerta del Hierro
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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:
- Histologically and/or cytologically confirmed diagnosis of advanced malignancy.
- Considered to be at risk of developing MBO, defined as PMMBO yellow classification, or presenting a clinical diagnosis of MBO, characterized by clinical evidence of bowel obstruction (based on medical history, physical examination, and/or radiological assessment) distal to the ligament of Treitz, and deemed suitable for ambulatory management.
- Receiving active oncologic therapy at the time of enrollment.
- Able to understand and communicate effectively in Spanish.
Exclusion Criteria:
- Inability to understand and communicate in Spanish.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: AI- Assisted Remote Monitoring + Standard Care
AI-Assisted Remote Symptom Monitoring An artificial intelligence-based conversational platform used to remotely assess symptoms associated with malignant bowel obstruction through automated telephone calls |
An artificial intelligence-based conversational platform used to remotely assess symptoms associated with malignant bowel obstruction through automated telephone calls. Patient responses generate predefined alerts that can be reviewed by healthcare professionals to support clinical management. |
|
Otro: Standard Care
Routine clinical management and follow-up |
Participants will receive routine clinical management and follow-up according to local standard-of-care practices. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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MBO-related hospital admissions
Periodo de tiempo: Within 90 days after randomization
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Proportion of participants experiencing at least one hospital admission due to malignant bowel obstruction (MBO) |
Within 90 days after randomization
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall survival
Periodo de tiempo: Up to 12 months after randomization
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Overall survival measured from active MBO development to death from any cause |
Up to 12 months after randomization
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Change in quality of life
Periodo de tiempo: Baseline and Day 90 (±14 days)
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Change from baseline in quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) questionnaire and gastrointestinal symptom subscale. The EORTC QLQ-C30 is a validated questionnaire used to assess health-related quality of life in patients with cancer. Scores range from 0 to 100. Higher scores on functional and global health status scales indicate better functioning and quality of life, whereas higher scores on symptom scales indicate greater symptom burden. The gastrointestinal symptom subscale evaluates the severity and frequency of gastrointestinal symptoms associated with malignant bowel obstruction. Higher scores indicate greater symptom burden and worsening gastrointestinal symptoms. |
Baseline and Day 90 (±14 days)
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Emergency department assessments due to MBO
Periodo de tiempo: Within 90 days after randomization
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Number of emergency department assessments related to MBO |
Within 90 days after randomization
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Time to first MBO-related hospital admission
Periodo de tiempo: Within 90 days after randomization
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Time from randomization to first hospital admission due to MBO |
Within 90 days after randomization
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Length of hospital stay due to MBO
Periodo de tiempo: Within 90 days after randomization
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Duration of hospital stays related to MBO in days |
Within 90 days after randomization
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Days alive and out of hospital
Periodo de tiempo: Within 90 days after randomization
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Ratio of days alive and out of hospital to days spent in hospital |
Within 90 days after randomization
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ainhoa Madariaga Urrutia, Hospital Universitario 12 de Octubre
- Investigador principal: Constanza Maximiano, Dra, Puerta de Hierro University Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- Madariaga A, Tuñon I, Sánchez-Castro S, et al: Automated conversational artificial intelligence (AI) for outpatient malignant bowel obstruction (MBO) symptom monitoring. Journal of Clinical Oncology 43:1547-1547, 2025
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
- Enfermedades urogenitales
- Enfermedades Genitales
- Enfermedades del sistema endocrino
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades intestinales
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Enfermedades Genitales Femeninas
- Neoplasias de glándulas endocrinas
- Enfermedades Ováricas
- Enfermedades anexiales
- Neoplasias Genitales Femeninas
- Trastornos gonadales
- Neoplasias Ováricas
- Neoplasias Gastrointestinales
- Obstrucción intestinal
- Administración de Servicios de Salud
- Calidad, acceso y evaluación de la atención médica
- Calidad de la atención médica
- Indicadores de calidad, atención médica
- Estándar de cuidado
Otros números de identificación del estudio
- SMART-MBO
Plan de datos de participantes individuales (IPD)
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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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