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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03260647
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : April 5, 2022
Information provided by (Responsible Party):
University Health Network, Toronto

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

Condition or disease Intervention/treatment
Gynecologic Cancer Other: Management algorithm for Malignant Bowel Obstruction

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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Risk Stratified Multidisciplinary Ambulatory Management of Malignant Bowel Obstruction (MAMBO) Program for Women With Advanced Gynecological Cancers
Actual Study Start Date : August 4, 2017
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Intervention Details:
  • 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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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. 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

  3. 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)

  4. 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

  5. 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)

  6. Improve patient understanding and awareness of MBO [ Time Frame: 2 years ]
    To improve patients' understanding and awareness of MBO with patient education material.

  7. 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

  8. 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

  9. Evaluate cannabis use in patient population [ Time Frame: 1.5 years ]
    Assess for any relationship between cannabis use and MBO

Biospecimen Retention:   Samples With DNA
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
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)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03260647

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Contact: Stephanie L'heureux 416-946-2818 ext 2818
Contact: Ruth Carey

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Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada
Contact: Amit Oza    416-946-2818   
Contact: Janany Sivalingam    416-946-4501 ext 2640   
Principal Investigator: Stephanie Lheureux, Dr         
Sponsors and Collaborators
University Health Network, Toronto
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Principal Investigator: Stephanie Lheureux University Health Network, Toronto
Martin-Lorente C, Mackay H, Lafromboise L, et al: Retrospective review of malignant bowel obstruction (MBO) outcomes in patients with epithelial ovarian carcinoma (EOC), International Journal of Gynecological Cancer, 2015, pp 1434-1435

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University Health Network, Toronto Identifier: NCT03260647    
Other Study ID Numbers: MAMBO
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: April 5, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases