An interventional study of AI-Assisted Remote Symptom Monitoring and Standard of Care in Malignant Bowel Obstruction and Intestinal Obstruction, sponsored by Hospital Universitario 12 de Octubre. Not yet recruiting at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Hospital Universitario 12 de Octubre · Not applicable, Interventional, and Supportive care
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:
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
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:
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
104 studies on the registry are indexed under Intestinal Obstruction; 15 are open to participants now.
This study's planned enrollment of 140 is above the median of 62 across 54 interventional studies indexed under Intestinal Obstruction.
Browse Intestinal Obstruction studies →Hospital Universitario 12 de Octubre is the lead sponsor of 34 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Routine clinical management and follow-up
Other: Standard of Care
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.
Participants will receive routine clinical management and follow-up according to local standard-of-care practices.
MBO-related hospital admissions
Proportion of participants experiencing at least one hospital admission due to malignant bowel obstruction (MBO)
Time frame: Within 90 days after randomization
Overall survival
Overall survival measured from active MBO development to death from any cause
Time frame: Up to 12 months after randomization
Change in quality of life
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.
Time frame: Baseline and Day 90 (±14 days)
Emergency department assessments due to MBO
Number of emergency department assessments related to MBO
Time frame: Within 90 days after randomization
Time to first MBO-related hospital admission
Time from randomization to first hospital admission due to MBO
Time frame: Within 90 days after randomization
Length of hospital stay due to MBO
Duration of hospital stays related to MBO in days
Time frame: Within 90 days after randomization
Days alive and out of hospital
Ratio of days alive and out of hospital to days spent in hospital
Time frame: Within 90 days after randomization
Plan to share: No
Start is estimated for Nov 2026; primary completion for Feb 2029, 27 months later.
Of 24 interventional studies with no phase under Intestinal Obstruction, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 59. This study's planned 27 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Hospital Universitario 12 de Octubre