Critical Care Outcomes of Hematologic Oncology Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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. 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. 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. 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. FACT-BMT: A 47-item, valid and reliable measure of five dimensions of quality of life.

Official Title
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Critical Care Outcomes of Patients With Hematologic Malignancy and Hematopoietic Cell Transplantation

Conditions
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Hematologic Malignancy, Stem Cell Transplant

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 year survival | 1 year survival in enrolled patients | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensive Care Unit survival | ICU survival in enrolled patients | 1 year | 
| 6 month functional outcome measured by the 6 minute walk test (6MWT) | 6MWT will be performed to assess exercise capacity at 6 months | 6 months | 
| 6 month Functional Independent Measure questionnaire (FIM) | FIM: Captures burden of care on a daily basis and involves motor and cognitive function. FIM predicts disability outcome and rehabilitation needs. | 6 months | 
| 6 month 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 | 6 months | 
| 6 month Short Form 36 Health 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. | 6 months | 
| 6 month Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT BMT) | FACT-BMT: A 47-item, valid and reliable measure of five dimensions of quality of life. | 6 months | 
| 1 year functional outcome measured by the 6 minute walk test (6MWT) | 6MWT will be performed to assess exercise capacity at 6 months | 1 year | 
| 1 year Functional Independent Measure questionnaire (FIM) | FIM: Captures burden of care on a daily basis and involves motor and cognitive function. FIM predicts disability outcome and rehabilitation needs. | 1 year | 
| 1 year 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 | 1 year | 
| 1 year Short Form 36 Health 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. | 1 year | 
| 1 year Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT BMT) | FACT-BMT: A 47-item, valid and reliable measure of five dimensions of quality of life. | 1 year |