Critical Care Outcomes of Hematologic Oncology Patients

NCT ID: NCT03449953

Last Updated: 2024-11-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 415 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-26
• Study Completion Date: 2026-12-31

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.

Conditions

Hematologic Malignancy; Stem Cell Transplant

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mount Sinai Hospital, Canada

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Laveena Munshi, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

Foothills Hospital

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

University of Manitoba

Winnipeg, Manitoba, Canada

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Juravinski Hospital

Hamilton, Ontario, Canada

Kingston General Hospital

Kingston, Ontario, Canada

Ottawa Hospital

Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

Royal Victoria Hospital

Montreal, Quebec, Canada

Countries

Canada

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Other Identifiers

COHO vOct2017

Identifier Type: -

Identifier Source: org_study_id