AI-Assisted Remote Monitoring for Patients With or at Risk of Malignant Bowel Obstruction

November 6, 2026 updated by: Hospital Universitario 12 de Octubre

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
    • Madrid
      • Majadahonda, Madrid, Spain, 28041
        • Hospital Universitario Puerta del Hierro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Device: 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. Patient responses generate predefined alerts that can be reviewed by healthcare professionals to support clinical management.
Other: Standard Care

Routine clinical management and follow-up
Other: Standard of Care

Participants will receive routine clinical management and follow-up according to local standard-of-care practices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MBO-related hospital admissions
Time Frame: Within 90 days after randomization

Proportion of participants experiencing at least one hospital admission due to malignant bowel obstruction (MBO)
Within 90 days after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Up to 12 months after randomization

Overall survival measured from active MBO development to death from any cause
Up to 12 months after randomization
Change in quality of life
Time Frame: Baseline and Day 90 (±14 days)

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)
Emergency department assessments due to MBO
Time Frame: Within 90 days after randomization

Number of emergency department assessments related to MBO
Within 90 days after randomization
Time to first MBO-related hospital admission
Time Frame: Within 90 days after randomization

Time from randomization to first hospital admission due to MBO
Within 90 days after randomization
Length of hospital stay due to MBO
Time Frame: Within 90 days after randomization

Duration of hospital stays related to MBO in days
Within 90 days after randomization
Days alive and out of hospital
Time Frame: Within 90 days after randomization

Ratio of days alive and out of hospital to days spent in hospital
Within 90 days after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario 12 de Octubre

Investigators

  • Principal Investigator: Ainhoa Madariaga Urrutia, Hospital Universitario 12 de Octubre
  • Principal Investigator: Constanza Maximiano, Dra, Puerta de Hierro University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

November 1, 2029

Study Registration Dates

First Submitted

November 6, 2026

First Submitted That Met QC Criteria

November 6, 2026

First Posted (Actual)

November 12, 2026

Study Record Updates

Last Update Posted (Actual)

November 12, 2026

Last Update Submitted That Met QC Criteria

November 6, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMART-MBO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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