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

Study Overview
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Brief Summary
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Management of Malignant Bowel Obstruction (MBO) in Patients with Advanced Gynecological Cancers

Detailed Description
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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.

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

Conditions
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Gynecologic Cancer

Intervention / Treatment
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* Other: Management algorithm for Malignant Bowel Obstruction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Management algorithm for Malignant Bowel Obstruction|a proposed management algorithm for MBO has been developed to provide a pathway that safeguards quality and continuity of care for patients under a multidisciplinary team. It will engage key-stakeholders and foster an inter-professional approach. It incorporates an in-patient management algorithm and a novel nursing-led ambulatory management algorithm to supplement patient's medical management|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimization of multidisciplinary care | 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 | 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 | 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 | 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 | To evaluate the nutritional status of patients with MBO • Measured by monthly albumin and weight | 2 years | 
| Evaluation of clinico-pathological factors | 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 | To improve patients' understanding and awareness of MBO with patient education material. | 2 years | 
| Determine percentage number of patient microbiome sample analyses completed | 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 | 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 | Assess for any relationship between cannabis use and MBO | 1.5 years |