Mosaic Trial for Stem Cell Transplant Recipients
NCT06960993
Blood Protein Disorders, Bone Marrow Diseases
Washington D.C., District of Columbia, United States
View Trial DetailsNCT Number: NCT03449953
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.
This study is active but is not currently recruiting participants.
16 year and older
All sexes
Observational
Foothills Hospital, Calgary, Alberta, Canada
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1 year
1 year survival in enrolled patients
Time frame: 1 year
ICU survival in enrolled patients
Time frame: 6 months
6MWT will be performed to assess exercise capacity at 6 months
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.
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
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.
Time frame: 6 months
FACT-BMT: A 47-item, valid and reliable measure of five dimensions of quality of life.
Time frame: 1 year
6MWT will be performed to assess exercise capacity at 6 months
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.
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
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.
Time frame: 1 year
FACT-BMT: A 47-item, valid and reliable measure of five dimensions of quality of life.
Mount Sinai Hospital, Canada
Other
Critical Care Outcomes of Patients With Hematologic Malignancy and Hematopoietic Cell Transplantation
Acronym: COHO
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.
Published trials that share one or more normalized conditions with this study.
NCT06960993
Blood Protein Disorders, Bone Marrow Diseases
Washington D.C., District of Columbia, United States
View Trial DetailsNCT03890614
Hematologic Diseases, Hematologic Malignancy
Winston-Salem, North Carolina, United States
View Trial DetailsNCT02041416
Cancer, Hematologic Diseases
Duarte, California, United States
View Trial DetailsNCT03431090
Anemia, Anemia, Refractory
Columbus, Ohio, United States
View Trial Details