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Active, Not Recruiting

NCT Number: NCT03449953

Critical Care Outcomes of Hematologic Oncology Patients

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Foothills Hospital, Calgary, Alberta, Canada

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About this study

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:

  • 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.
  • 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.
  • 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.
  • 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.
  • FACT-BMT: A 47-item, valid and reliable measure of five dimensions of quality of life.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 1 year survival

    Time frame: 1 year

    1 year survival in enrolled patients

Secondary outcomes

  1. Intensive Care Unit survival

    Time frame: 1 year

    ICU survival in enrolled patients

  2. 6 month functional outcome measured by the 6 minute walk test (6MWT)

    Time frame: 6 months

    6MWT will be performed to assess exercise capacity at 6 months

  3. 6 month Functional Independent Measure questionnaire (FIM)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 1 year

    6MWT will be performed to assess exercise capacity at 6 months

  8. 1 year Functional Independent Measure questionnaire (FIM)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 1 year

    FACT-BMT: A 47-item, valid and reliable measure of five dimensions of quality of life.

Sponsors and collaborators

Lead sponsor

Mount Sinai Hospital, Canada

Other

Registry information

Official study title

Critical Care Outcomes of Patients With Hematologic Malignancy and Hematopoietic Cell Transplantation

Acronym: COHO

Important dates

Study start
2018
Primary completion
2025
Study completion
2026
First posted
Feb 28, 2018
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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