Risk Stratified Multidisciplinary Ambulatory Management of Malignant Bowel Obstruction in Gynecological Cancers
- Conditions
- Gynecologic Cancer
- Registration Number
- NCT03260647
- Lead Sponsor
- University Health Network, Toronto
- Brief Summary
Management of Malignant Bowel Obstruction (MBO) in Patients with Advanced Gynecological Cancers
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 150
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.
There are no specified exclusion criteria for this study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Optimization of multidisciplinary care 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
- Secondary Outcome Measures
Name Time Method Improve patient understanding and awareness of MBO 2 years To improve patients' understanding and awareness of MBO with patient education material.
Evaluation of impact of MBO management on patient reported outcomes 2 years To evaluate the impact of ambulatory MBO management on patient reported outcomes using the Distress Assessment \& Response Tool (DART)
To evaluate nutritional status of patients with MBO 2 years To evaluate the nutritional status of patients with MBO
• Measured by monthly albumin and weightEvaluation of clinico-pathological factors 2 years To evaluate the clinico-pathological factors that may predict benefit from palliative surgery, chemotherapy and total parenteral nutrition (TPN)
Record changes in the sum and types of gut microbiome from baseline to study end 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
Determine percentage number of patient microbiome sample analyses completed 1.5 years To record the percentage of patients who agree to, and for whom sample collection and analysis is completed
Evaluate cannabis use in patient population 1.5 years Assess for any relationship between cannabis use and MBO
Evaluation of treatment outcomes 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 systemEvaluation of impact of MBO management on hospital visits 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
Trial Locations
- Locations (1)
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada