Risk Stratified Multidisciplinary Ambulatory Management of Malignant Bowel Obstruction in Gynecological Cancers (MAMBO)

June 17, 2025 updated by: University Health Network, Toronto

Risk Stratified Multidisciplinary Ambulatory Management of Malignant Bowel Obstruction (MAMBO) Program for Women With Advanced Gynecological Cancers

Management of Malignant Bowel Obstruction (MBO) in Patients with Advanced Gynecological Cancers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Guidelines for the management of patients with Malignant Bowel Obstruction(MBO) are not available and as such, there remains an urgent need for a collaborative approach to streamline patient care and optimize use of hospital resources. This study will focus on management of MBO in advanced gynecological cancers.If patients with MBO can be effectively managed in an ambulatory setting, this may improve quality and consistency of patient care, and help reduce volume and duration of bed occupancy.

Study Type

Observational

Enrollment (Actual)

96

Contacts and Locations

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

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Princess Margaret Cancer Centre

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 to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with gynecological cancer and at risk or presently having Malignant bowel obstruction (MBO)

Description

Inclusion Criteria:

Histologically and /or cytologically confirmed gynecological cancer, including ovarian, fallopian tube, endometrial, cervical or primary peritoneal cancer Deemed to be at risk of developing or have a clinical diagnosis of MBO as defined using the following criteria: clinical evidence of bowel obstruction (history/physical/radiological examination; and bowel obstruction beyond the ligament of Treitz.

Exclusion Criteria:

There are no specified exclusion criteria for this study

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optimization of multidisciplinary care
Time Frame: 2 years

To optimize the multidisciplinary care management of MBO in patients with advanced gynecological cancer treated at University Health Network (UHN) which include in-patient and ambulatory management algorithm for MBO

• Measured by a ratio of days alive and out of hospital compare to days in hospital within the first 60 days after diagnosis of MBO
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of treatment outcomes
Time Frame: 2 years

To evaluate the treatment outcomes of patients with MBO

  • Measured by resolution of MBO and overall survival
  • Measured by transition through specific bowel management colour code system
2 years
Evaluation of impact of MBO management on hospital visits
Time Frame: 2 years
To evaluate the impact of MBO management on number of emergency room visits, hospital admission and number of days alive and outside of hospital within the first 168 days (6 months) after the diagnosis of MBO
2 years
Evaluation of impact of MBO management on patient reported outcomes
Time Frame: 2 years
To evaluate the impact of ambulatory MBO management on patient reported outcomes using the Distress Assessment & Response Tool (DART)
2 years
To evaluate nutritional status of patients with MBO
Time Frame: 2 years

To evaluate the nutritional status of patients with MBO

• Measured by monthly albumin and weight
2 years
Evaluation of clinico-pathological factors
Time Frame: 2 years
To evaluate the clinico-pathological factors that may predict benefit from palliative surgery, chemotherapy and total parenteral nutrition (TPN)
2 years
Improve patient understanding and awareness of MBO
Time Frame: 2 years
To improve patients' understanding and awareness of MBO with patient education material.
2 years
Determine percentage number of patient microbiome sample analyses completed
Time Frame: 1.5 years
To record the percentage of patients who agree to, and for whom sample collection and analysis is completed
1.5 years
Record changes in the sum and types of gut microbiome from baseline to study end
Time Frame: 1.5 years
Changes in the sum as well as types of microbiomes as recorded at baseline, initiation of total parenteral nutrition, incidence of an MBO and end of study are to be recorded
1.5 years
Evaluate cannabis use in patient population
Time Frame: 1.5 years
Assess for any relationship between cannabis use and MBO
1.5 years

Collaborators and Investigators

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

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Stephanie Lheureux, University Health Network, Toronto

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

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 (Actual)

August 4, 2017

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

August 21, 2017

First Submitted That Met QC Criteria

August 21, 2017

First Posted (Actual)

August 24, 2017

Study Record Updates

Last Update Posted (Actual)

June 22, 2025

Last Update Submitted That Met QC Criteria

June 17, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAMBO

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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