An observational study in Hematologic Malignancy and Stem Cell Transplant, sponsored by Mount Sinai Hospital, Canada. Active, not recruiting at 13 sites in Canada. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by Mount Sinai Hospital, Canada · Observational
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.
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:
1,494 studies on the registry are indexed under Hematologic Neoplasms; 438 are open to participants now.
This study's enrollment of 415 is above the median of 200 across 331 observational studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Mount Sinai Hospital, Canada is the lead sponsor of 158 studies on the registry; 32 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1 year survival
1 year survival in enrolled patients
Time frame: 1 year
Intensive Care Unit survival
ICU survival in enrolled patients
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 1 year
Plan to share: No
This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Mount Sinai Hospital, Canada →