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

Gynecologic Cancer Clinical Trial

— MAMBO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03260647
• Other study ID #: MAMBO
• Status: Recruiting
• Start date: August 4, 2017
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: University Health Network, Toronto
• Contact: Stephanie L'heureux
• Phone: 416-946-2818
• Email: stephanie.lheureux[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Cancer
• Intestinal Obstruction

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

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (24)

Abu-Rustum NR, Barakat RR, Venkatraman E, Spriggs D. Chemotherapy and total parenteral nutrition for advanced ovarian cancer with bowel obstruction. Gynecol Oncol. 1997 Mar;64(3):493-5. doi: 10.1006/gyno.1996.4605. — View Citation

Anthony T, Baron T, Mercadante S, Green S, Chi D, Cunningham J, Herbst A, Smart E, Krouse RS. Report of the clinical protocol committee: development of randomized trials for malignant bowel obstruction. J Pain Symptom Manage. 2007 Jul;34(1 Suppl):S49-59. doi: 10.1016/j.jpainsymman.2007.04.011. Epub 2007 Jun 4. — View Citation

Brard L, Weitzen S, Strubel-Lagan SL, Swamy N, Gordinier ME, Moore RG, Granai CO. The effect of total parenteral nutrition on the survival of terminally ill ovarian cancer patients. Gynecol Oncol. 2006 Oct;103(1):176-80. doi: 10.1016/j.ygyno.2006.02.013. Epub 2006 Mar 27. — View Citation

Bryan DN, Radbod R, Berek JS. An analysis of surgical versus chemotherapeutic intervention for the management of intestinal obstruction in advanced ovarian cancer. Int J Gynecol Cancer. 2006 Jan-Feb;16(1):125-34. doi: 10.1111/j.1525-1438.2006.00283.x. — View Citation

Chouhan J, Gupta R, Ensor J, Raghav K, Fogelman D, Wolff RA, Fisch M, Overman MJ. Retrospective analysis of systemic chemotherapy and total parenteral nutrition for the treatment of malignant small bowel obstruction. Cancer Med. 2016 Feb;5(2):239-47. doi: 10.1002/cam4.587. Epub 2015 Dec 29. — View Citation

Cousins SE, Tempest E, Feuer DJ. Surgery for the resolution of symptoms in malignant bowel obstruction in advanced gynaecological and gastrointestinal cancer. Cochrane Database Syst Rev. 2016 Jan 4;2016(1):CD002764. doi: 10.1002/14651858.CD002764.pub2. — View Citation

Daniele A, Ferrero A, Fuso L, Mineccia M, Porcellana V, Vassallo D, Biglia N, Menato G. Palliative care in patients with ovarian cancer and bowel obstruction. Support Care Cancer. 2015 Nov;23(11):3157-63. doi: 10.1007/s00520-015-2694-9. Epub 2015 Mar 25. — View Citation

Diver E, O'Connor O, Garrett L, Boruta D, Goodman A, Del Carmen M, Schorge J, Mueller P, Growdon W. Modest benefit of total parenteral nutrition and chemotherapy after venting gastrostomy tube placement. Gynecol Oncol. 2013 May;129(2):332-5. doi: 10.1016/j.ygyno.2013.02.002. Epub 2013 Feb 8. — View Citation

Feuer DJ, Broadley KE, Shepherd JH, Barton DP. Surgery for the resolution of symptoms in malignant bowel obstruction in advanced gynaecological and gastrointestinal cancer. Cochrane Database Syst Rev. 2000;(4):CD002764. doi: 10.1002/14651858.CD002764. — View Citation

Furnes B, Svensen R, Helland H, Ovrebo K. Challenges and outcome of surgery for bowel obstruction in women with gynaecologic cancer. Int J Surg. 2016 Mar;27:158-164. doi: 10.1016/j.ijsu.2016.02.002. Epub 2016 Feb 4. — View Citation

Goto T, Takano M, Aoyama T, Miyamoto M, Watanabe A, Kato M, Sasaki N, Hirata J, Sasa H, Furuya K. Outcomes of palliative bowel surgery for malignant bowel obstruction in patients with gynecological malignancy. Oncol Lett. 2012 Nov;4(5):883-888. doi: 10.3892/ol.2012.835. Epub 2012 Jul 30. — View Citation

Jayson GC, Kohn EC, Kitchener HC, Ledermann JA. Ovarian cancer. Lancet. 2014 Oct 11;384(9951):1376-88. doi: 10.1016/S0140-6736(13)62146-7. Epub 2014 Apr 21. — View Citation

Kolomainen DF, Daponte A, Barton DP, Pennert K, Ind TE, Bridges JE, Shepherd JH, Gore ME, Kaye SB, Riley J. Outcomes of surgical management of bowel obstruction in relapsed epithelial ovarian cancer (EOC). Gynecol Oncol. 2012 Apr;125(1):31-6. doi: 10.1016/j.ygyno.2011.11.007. Epub 2011 Nov 12. — View Citation

Kucukmetin A, Naik R, Galaal K, Bryant A, Dickinson HO. Palliative surgery versus medical management for bowel obstruction in ovarian cancer. Cochrane Database Syst Rev. 2010 Jul 7;2010(7):CD007792. doi: 10.1002/14651858.CD007792.pub2. — View Citation

Levy M, Smith T, Alvarez-Perez A, Back A, Baker JN, Beck AC, Block S, Dalal S, Dans M, Fitch TR, Kapo J, Kutner JS, Kvale E, Misra S, Mitchell W, Portman DG, Sauer TM, Spiegel D, Sutton L, Szmuilowicz E, Taylor RM, Temel J, Tickoo R, Urba SG, Weinstein E, Zachariah F, Bergman MA, Scavone JL. Palliative Care Version 1.2016. J Natl Compr Canc Netw. 2016 Jan;14(1):82-113. doi: 10.6004/jnccn.2016.0009. — View Citation

Li M, Macedo A, Crawford S, Bagha S, Leung YW, Zimmermann C, Fitzgerald B, Wyatt M, Stuart-McEwan T, Rodin G. Easier Said Than Done: Keys to Successful Implementation of the Distress Assessment and Response Tool (DART) Program. J Oncol Pract. 2016 May;12(5):e513-26. doi: 10.1200/JOP.2015.010066. Epub 2016 Apr 5. — View Citation

Mangili G, Aletti G, Frigerio L, Franchi M, Panacci N, Vigano R, DE Marzi P, Zanetto F, Ferrari A. Palliative care for intestinal obstruction in recurrent ovarian cancer: a multivariate analysis. Int J Gynecol Cancer. 2005 Sep-Oct;15(5):830-5. doi: 10.1111/j.1525-1438.2005.00144.x. — View Citation

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

Mooney SJ, Winner M, Hershman DL, Wright JD, Feingold DL, Allendorf JD, Neugut AI. Bowel obstruction in elderly ovarian cancer patients: a population-based study. Gynecol Oncol. 2013 Apr;129(1):107-12. doi: 10.1016/j.ygyno.2012.12.028. Epub 2012 Dec 26. — View Citation

Ripamonti C, Twycross R, Baines M, Bozzetti F, Capri S, De Conno F, Gemlo B, Hunt TM, Krebs HB, Mercadante S, Schaerer R, Wilkinson P; Working Group of the European Association for Palliative Care. Clinical-practice recommendations for the management of bowel obstruction in patients with end-stage cancer. Support Care Cancer. 2001 Jun;9(4):223-33. doi: 10.1007/s005200000198. — View Citation

Ripamonti CI, Easson AM, Gerdes H. Management of malignant bowel obstruction. Eur J Cancer. 2008 May;44(8):1105-15. doi: 10.1016/j.ejca.2008.02.028. Epub 2008 Mar 21. — View Citation

Sartori E, Chiudinelli F, Pasinetti B, Maggino T. Bowel obstruction and survival in patients with advanced ovarian cancer: analysis of prognostic variables. Int J Gynecol Cancer. 2009 Jan;19(1):54-7. doi: 10.1111/IGC.0b013e318198ff4b. No abstract available. — View Citation

Tran E, Spiceland C, Sandhu NP, Jatoi A. Malignant Bowel Obstruction in Patients With Recurrent Ovarian Cancer. Am J Hosp Palliat Care. 2016 Apr;33(3):272-5. doi: 10.1177/1049909114566225. Epub 2014 Dec 31. — View Citation

Tuca A, Guell E, Martinez-Losada E, Codorniu N. Malignant bowel obstruction in advanced cancer patients: epidemiology, management, and factors influencing spontaneous resolution. Cancer Manag Res. 2012;4:159-69. doi: 10.2147/CMAR.S29297. Epub 2012 Jun 13. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Improve patient understanding and awareness of MBO	To improve patients' understanding and awareness of MBO with patient education material.	2 years
Secondary	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
Secondary	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
Secondary	Evaluate cannabis use in patient population	Assess for any relationship between cannabis use and MBO	1.5 years