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Critical Care Outcomes of Hematologic Oncology Patients (COHO)

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.
 
ClinicalTrials.gov Identifier: NCT03449953
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Mount Sinai Hospital, Canada

Brief Summary:
Hematologic malignancy patients are admitted to ICU in increasing numbers. Successful ICU intervention has led to an increasing number of ICU survivors; however, there is a lack of information available about these patients' long term survival and quality of life. There is little Canadian data regarding ICU survival and regarding 1-year survival and functional outcomes in this group of patients. Over 500 patients are admitted annually to Canadian ICUs with an underlying hematologic malignancy or stem cell transplant, yet there is a paucity of up to date long-term outcome data. This information will facilitate a better understanding who would best benefit from critical care interventions and the impact of critical illness on their level of function at 1 year as well as survival.

Condition or disease
Hematologic Malignancy Stem Cell Transplant

Detailed Description:

At the time of ICU admission, the investigators will collect clinical data from the medical chart on a daily basis including demographics, pre-existing disease(s), treatment and reason for ICU admission.

At the time of ICU discharge, the investigators will measure exercise tolerance and quality of life at 3 time intervals (Phase 2).

For Phase 2, patients will be seen at day 7 following ICU discharge, 6 months following ICU discharge and 12 months after ICU discharge during their routine oncology follow up visits. During these visits, they will undergo a functional assessment (6 minute walk test) and questionnaires to determine their quality of life following ICU (validated outcome measures).

All patients will complete outcome measures 1 to 5 below; Outcome measures 1 to 3 will be administered at 7 days and 1 to 5 at 6 months and 12 months after ICU discharge.

Validated Outcomes Measures:

  1. Functional Independence Measure (FIM): a patient-centered measure of functional disability that captures burden of care on a daily basis and involves motor (FIM-motor) and cognitive function (FIM-cognition). FIM predicts disability outcome and rehabilitation needs in diverse patient populations.
  2. Six Minute Walk Test (6MWT) with continuous oximetry to measure the oxygen saturation of arterial blood will be performed to assess exercise capacity. It is simple to execute, inexpensive, standardized and gives a tangible measure of functional exercise capacity because it uses an exercise mode that is relevant to everyday activities.
  3. Clinical Frailty Scale (CFS): CFS is a 9-category tool ranging from 1 (Very fit) to 9 (Terminally ill). It provides predictive information about death or need for an institution. It is easy to administer in less than 5 minutes.
  4. Medical Outcomes Study Short Form - 36 Questionnaire (SF-36): SF-36 evaluates 8 health concepts: physical functioning, role functioning-physical, bodily pain, general health, vitality, social functioning, role functioning- emotional, mental health and reported health transition. It has been validated in diverse patient populations and is a responsive and reproducible instrument; and can be completed in less than 15 minutes.
  5. FACT-BMT: A 47-item, valid and reliable measure of five dimensions of quality of life.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Critical Care Outcomes of Patients With Hematologic Malignancy and Hematopoietic Cell Transplantation
Actual Study Start Date : February 26, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Critical Care




Primary Outcome Measures :
  1. 1 year survival [ Time Frame: 1 year ]
    1 year survival in enrolled patients


Secondary Outcome Measures :
  1. Intensive Care Unit survival [ Time Frame: 1 year ]
    ICU survival in enrolled patients

  2. 6 month functional outcome measured by the 6 minute walk test (6MWT) [ Time Frame: 6 months ]
    6MWT will be performed to assess exercise capacity at 6 months

  3. 6 month Functional Independent Measure questionnaire (FIM) [ Time Frame: 6 months ]
    FIM: Captures burden of care on a daily basis and involves motor and cognitive function. FIM predicts disability outcome and rehabilitation needs.

  4. 6 month Clinical Frailty Scale (CFS) [ Time Frame: 6 months ]
    CFS: Is a 9-category tool ranging from 1 (Very fit) to 9 (Terminally ill). It provides predictive information about death or need for an institution

  5. 6 month Short Form 36 Health Questionnaire (SF 36) [ Time Frame: 6 months ]
    SF-36: Evaluates 8 health concepts: physical functioning, role functioning-physical, bodily pain, general health, vitality, social functioning, role functioning- emotional, mental health and reported health transition.

  6. 6 month Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT BMT) [ Time Frame: 6 months ]
    FACT-BMT: A 47-item, valid and reliable measure of five dimensions of quality of life.

  7. 1 year functional outcome measured by the 6 minute walk test (6MWT) [ Time Frame: 1 year ]
    6MWT will be performed to assess exercise capacity at 6 months

  8. 1 year Functional Independent Measure questionnaire (FIM) [ Time Frame: 1 year ]
    FIM: Captures burden of care on a daily basis and involves motor and cognitive function. FIM predicts disability outcome and rehabilitation needs.

  9. 1 year Clinical Frailty Scale (CFS) [ Time Frame: 1 year ]
    CFS: Is a 9-category tool ranging from 1 (Very fit) to 9 (Terminally ill). It provides predictive information about death or need for an institution

  10. 1 year Short Form 36 Health Questionnaire (SF 36) [ Time Frame: 1 year ]
    SF-36: Evaluates 8 health concepts: physical functioning, role functioning-physical, bodily pain, general health, vitality, social functioning, role functioning- emotional, mental health and reported health transition.

  11. 1 year Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT BMT) [ Time Frame: 1 year ]
    FACT-BMT: A 47-item, valid and reliable measure of five dimensions of quality of life.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with hematologic malignancy (HM) and hematopoietic cell transplantation (HCT) frequently develop life-threatening illness and require admission to an intensive care unit (ICU). In light of advancements in care and extension of treatments to much higher risk candidates, survival and functional outcome evaluation become crucial for informed development of practice guidelines to guide pre-ICU risk stratification, as well as ICU and post-ICU care. Robust and up to date long-term data on ICU morbidity and mortality outcomes are lacking.
Criteria

Inclusion Criteria:

  • Subjects >16 years with Hematologic Malignancy (HM) or post Stem Cell Transplant (HCT) who require ICU admission.
  • HM includes: acute myeloid leukemia, acute lymphocytic leukemia, chronic myeloid leukemia, chronic lymphocytic leukemia, myeloma, lymphoma, myelofibrosis, and other myeloproliferative disorders or myelodysplastic syndromes.
  • HCT is defined as the transplantation of multipotent hematopoietic stem cells from bone marrow, peripheral blood, or umbilical cord blood.

Exclusion Criteria:

  • Subjects with significant preexisting neurological or psychiatric disease will be excluded from Phase 2 (1-year follow-up) but will be included in Phase 1.

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 ClinicalTrials.gov identifier (NCT number): NCT03449953


Contacts
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Contact: Dr. Laveena Munshi, MD, FRCPC 416-586-4800 ext 6571 Laveena.Munshi@sinaihealthsystem.ca
Contact: Dr. Sangeeta Mehta, MD, FRCPC 416-586-4800 ext 4604 geeta.mehta@utoronto.ca

Locations
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Canada, Alberta
Foothills Hospital Not yet recruiting
Calgary, Alberta, Canada, T2N 2T9
Principal Investigator: Paul Boiteau, MD         
University of Alberta Not yet recruiting
Edmonton, Alberta, Canada, T6G 2R3
Contact: Nadia Baig         
Principal Investigator: Sean Bagshaw, MD         
Canada, British Columbia
Vancouver General Hospital Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Michelle Storms         
Principal Investigator: Donald Griesdale, MD         
Canada, Manitoba
University of Manitoba Not yet recruiting
Winnipeg, Manitoba, Canada, R3T 2N2
Contact: Nicole Marten         
Contact: Justin Lys         
Principal Investigator: Ryan Zarychanski, MD         
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Contact: Tamara Mitterer         
Principal Investigator: Robert Green, MD         
Canada, Ontario
Juravinski Hospital Recruiting
Hamilton, Ontario, Canada, L8V 1C3
Contact: Tina Millen, RRT         
Principal Investigator: Bram Rochwerg, MD         
Kingston General Hospital Not yet recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Miranda Hunt         
Contact: Ilinca Georgescu         
Principal Investigator: Paul Heffernan, MD         
Ottawa Hospital Not yet recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Irene Watpool         
Principal Investigator: Rakesh Patel, MD         
Sunnybrook Health Sciences Centre Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Nicole Marinoff         
Principal Investigator: Damon Scales, MD         
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Prakruti Palepu    4165864800      
Principal Investigator: Sangeeta Mehta, MD         
University Health Network Not yet recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Prakruthi Palepu         
Principal Investigator: Santhosh Thyagu, MD, DM         
Canada, Quebec
Royal Victoria Hospital Not yet recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Josie Campisi    514-934-1934 ext 65542    Josie.Campisi@MUHC.MCGILL.CA   
Principal Investigator: Sheldon Magder, MD         
Maisonneuve-Rosemont Hospital Not yet recruiting
Montréal, Quebec, Canada, H1T 2M4
Contact: Johanne Harvey         
Contact: Danae Tassy         
Principal Investigator: Han Ting Wang, MD         
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Investigators
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Principal Investigator: Dr. Laveena Munshi, MD, FRCPC MOUNT SINAI HOSPITAL
Publications:
Cuthbertson BH, Rajalingam Y, Harrison S, McKirdy F, On behalf of the Scottish Intensive Care Society. The outcome of haematological malignancy in Scottish intensive care units. JICS 2008; 9 (2)
Hampshire PA, Pugh R, Hajimichael P. Outcomes for critically ill patients with haematological malignancies in specialist and non-specialist centres in the United Kingdom. Journal of Cancer Therapeutics & Research 2014, http://www.hoajonline.com/journals/pdf/2049-7962-3-5.pdf
Bell C, Liu J, Debacker J, Tamberg E, Campbell V, Lee C, Mehta S. Noninvasive ventilation in patients with haematologic malignancy: a retrospective review. Critical Care 2016; 20 (Suppl 2): P234.
MacEachern KN, Kraguljac AP, Mehta S. Nutrition care of critically ill patients with leukemia: a retrospective review. Intensive Care Med 2014;40(1):S0286.
Ware JE J, Kosinski M, Gandek B. SF-36 Health Survey: manual and interpretation guide. Lincoln,R.I.: QualityMetric Inc.; 2002.

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Responsible Party: Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT03449953    
Other Study ID Numbers: COHO vOct2017
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
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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Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases