Critical Care Outcomes of Hematologic Oncology Patients
- Conditions
- Hematologic MalignancyStem Cell Transplant
- Registration Number
- NCT03449953
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 415
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 year survival 1 year 1 year survival in enrolled patients
- Secondary Outcome Measures
Name Time Method 6 month Clinical Frailty Scale (CFS) 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
6 month Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT BMT) 6 months FACT-BMT: A 47-item, valid and reliable measure of five dimensions of quality of life.
1 year functional outcome measured by the 6 minute walk test (6MWT) 1 year 6MWT will be performed to assess exercise capacity at 6 months
1 year Clinical Frailty Scale (CFS) 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
1 year Short Form 36 Health Questionnaire (SF 36) 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.
6 month Functional Independent Measure questionnaire (FIM) 6 months FIM: Captures burden of care on a daily basis and involves motor and cognitive function. FIM predicts disability outcome and rehabilitation needs.
1 year Functional Independent Measure questionnaire (FIM) 1 year FIM: Captures burden of care on a daily basis and involves motor and cognitive function. FIM predicts disability outcome and rehabilitation needs.
Intensive Care Unit survival 1 year ICU survival in enrolled patients
6 month functional outcome measured by the 6 minute walk test (6MWT) 6 months 6MWT will be performed to assess exercise capacity at 6 months
6 month Short Form 36 Health Questionnaire (SF 36) 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.
1 year Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT BMT) 1 year FACT-BMT: A 47-item, valid and reliable measure of five dimensions of quality of life.
Trial Locations
- Locations (13)
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
Foothills Hospital
🇨🇦Calgary, Alberta, Canada
University of Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
Juravinski Hospital
🇨🇦Hamilton, Ontario, Canada
University Health Network
🇨🇦Toronto, Ontario, Canada
Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
Maisonneuve-Rosemont Hospital
🇨🇦Montréal, Quebec, Canada
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Royal Victoria Hospital
🇨🇦Montreal, Quebec, Canada
Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada