Clinical trial NCT03260647: Risk Stratified Multidisciplinary Ambulatory Management of Malignant Bowel Obstruction in Gynecological Cancers
Official title: Risk Stratified Multidisciplinary Ambulatory Management of Malignant Bowel Obstruction (MAMBO) Program for Women With Advanced Gynecological Cancers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gynecologic Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with gynecological cancer and at risk or presently having Malignant bowel obstruction (MBO)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Optimization of multidisciplinary care
timeFrame: 2 years
Secondary outcomes:
measure: Evaluation of treatment outcomes
timeFrame: 2 years
measure: Evaluation of impact of MBO management on hospital visits
timeFrame: 2 years
measure: Evaluation of impact of MBO management on patient reported outcomes
timeFrame: 2 years
measure: To evaluate nutritional status of patients with MBO
timeFrame: 2 years
measure: Evaluation of clinico-pathological factors
timeFrame: 2 years
measure: Improve patient understanding and awareness of MBO
timeFrame: 2 years
measure: Determine percentage number of patient microbiome sample analyses completed
timeFrame: 1.5 years
measure: Record changes in the sum and types of gut microbiome from baseline to study end
timeFrame: 1.5 years
measure: Evaluate cannabis use in patient population
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Stephanie Lheureux
role: PRINCIPAL_INVESTIGATOR
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