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COHO: Critical Care Outcomes of Hematologic Oncology Patients

Sponsor
Mount Sinai Hospital, Canada (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03449953
Collaborator
(none)
415
Enrollment
13
Locations
58.1
Anticipated Duration (Months)
31.9
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    415 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Critical Care Outcomes of Patients With Hematologic Malignancy and Hematopoietic Cell Transplantation
    Actual Study Start Date :
    Feb 26, 2018
    Anticipated Primary Completion Date :
    Jun 30, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 1 year survival [1 year]

      1 year survival in enrolled patients

    Secondary Outcome Measures

    1. Intensive Care Unit survival [1 year]

      ICU survival in enrolled patients

    2. 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

    3. 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.

    4. 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

    5. 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.

    6. 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.

    7. 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

    8. 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.

    9. 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

    10. 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.

    11. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Foothills Hospital Calgary Alberta Canada T2N 2T9
    2 University of Alberta Edmonton Alberta Canada T6G 2R3
    3 Vancouver General Hospital Vancouver British Columbia Canada V5Z 1M9
    4 University of Manitoba Winnipeg Manitoba Canada R3T 2N2
    5 Queen Elizabeth II Health Sciences Centre Halifax Nova Scotia Canada B3H 2Y9
    6 Juravinski Hospital Hamilton Ontario Canada L8V 1C3
    7 Kingston General Hospital Kingston Ontario Canada K7L 2V7
    8 Ottawa Hospital Ottawa Ontario Canada K1H 8L6
    9 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5
    10 Mount Sinai Hospital Toronto Ontario Canada M5G 1X5
    11 University Health Network Toronto Ontario Canada M5G 2M9
    12 Royal Victoria Hospital Montreal Quebec Canada H4A 3J1
    13 Maisonneuve-Rosemont Hospital Montréal Quebec Canada H1T 2M4

    Sponsors and Collaborators

    • Mount Sinai Hospital, Canada

    Investigators

    • Principal Investigator: Dr. Laveena Munshi, MD, FRCPC, MOUNT SINAI HOSPITAL

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mount Sinai Hospital, Canada
    ClinicalTrials.gov Identifier:
    NCT03449953
    Other Study ID Numbers:
    • COHO vOct2017
    First Posted:
    Feb 28, 2018
    Last Update Posted:
    Sep 5, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms
    Hematologic Neoplasms

    Study Results

    No Results Posted as of Sep 5, 2021