Clinical trial NCT03449953: Critical Care Outcomes of Hematologic Oncology Patients
Official title: Critical Care Outcomes of Patients With Hematologic Malignancy and Hematopoietic Cell Transplantation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hematologic Malignancy
Stem Cell Transplant
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 415
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: 1 year survival
timeFrame: 1 year
Secondary outcomes:
measure: Intensive Care Unit survival
timeFrame: 1 year
measure: 6 month functional outcome measured by the 6 minute walk test (6MWT)
timeFrame: 6 months
measure: 6 month Functional Independent Measure questionnaire (FIM)
timeFrame: 6 months
measure: 6 month Clinical Frailty Scale (CFS)
timeFrame: 6 months
measure: 6 month Short Form 36 Health Questionnaire (SF 36)
timeFrame: 6 months
measure: 6 month Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT BMT)
timeFrame: 6 months
measure: 1 year functional outcome measured by the 6 minute walk test (6MWT)
timeFrame: 1 year
measure: 1 year Functional Independent Measure questionnaire (FIM)
timeFrame: 1 year
measure: 1 year Clinical Frailty Scale (CFS)
timeFrame: 1 year
measure: 1 year Short Form 36 Health Questionnaire (SF 36)
timeFrame: 1 year
measure: 1 year Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT BMT)
timeFrame: 1 year
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Juravinski Hospital
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Montréal
country: Canada
facility: Maisonneuve-Rosemont Hospital
state: Quebec
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Dr. Laveena Munshi, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
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