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

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ClinicalTrials.gov Identifier: NCT03260647
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : March 26, 2021
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date August 21, 2017
First Posted Date August 24, 2017
Last Update Posted Date March 26, 2021
Actual Study Start Date August 4, 2017
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 21, 2017)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 26, 2019)
  • 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
  • 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
  • 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)
  • 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
  • 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)
  • Improve patient understanding and awareness of MBO [ Time Frame: 2 years ]
    To improve patients' understanding and awareness of MBO with patient education material.
  • 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
  • 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
Original Secondary Outcome Measures
 (submitted: August 21, 2017)
  • 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
  • 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
  • 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)
  • 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
  • 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)
  • Improve patient understanding and awareness of MBO [ Time Frame: 2 years ]
    To improve patients' understanding and awareness of MBO with patient education material.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Patients with MBO who undergo palliative procedures or surgical intervention will be offered optional consent for tissue collection for research. Fresh-frozen and formalin-fixed paraffin-embedded (FFPE) tumour tissue specimens, as well as ascites will be collected for translational studies. Stool samples will be collected for microbiome analysis
Sampling Method Non-Probability Sample
Study Population Patients with gynecological cancer and at risk or presently having Malignant bowel obstruction (MBO)
Condition Gynecologic Cancer
Intervention 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
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 21, 2017)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
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

Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Female
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Siddika Pardhan 416-946-4501 ext 4753 siddika.pardhan@uhn.ca
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03260647
Other Study ID Numbers MAMBO
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Health Network, Toronto
Study Sponsor University Health Network, Toronto
Collaborators Not Provided
Investigators
Principal Investigator: Stephanie Lheureux University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date March 2021