Prospective observational multicenter study of allogeneic Hematopoietic Stem Cell Transplantation (HCT) in recipients 60 years and older to assess important determinants of health status to be combined into a composite health risk model to improve risk assessment of non-relapse mortality (NRM).
At baseline, standardized Geriatric Assessment (GA) tools incorporating subject reported data and bedside testing will be collected. HCT-Comorbidity Index (CI) scores will be assigned and C-reactive protein (CRP) and albumin will be measured locally. Serial measures at 3, 6, and 12 months for frailty, skilled facility admission, and quality of life (QOL) using PROMIS measures for physical function, depression and anxiety will be determined. Graft Versus Host Disease (GVHD) through one year, serious toxicities through day 100, cognitive status at day 100 and causes of death will be captured.
Study Type
OBSERVATIONAL
Enrollment
1,229
questionnaires, geriatric assessments
One Year Non-Relapse Mortality
To determine the set of assessments and biomarkers that could together constitute a robust and valid composite health risk model for accurate personalized estimation of NRM by analyzing data collected from all measures pre and post transplant.
Time frame: 1 year
Overall survival
Overall survival
Time frame: 1 year
Cumulative Incidence of Frailty
Cumulative Incidence of Frailty determined by score determined through the Hopkins Frailty Phenotype assessment on a scale of 0-5 where a score of 3 or more is considered 'frail'.
Time frame: 1 Year
Cumulative incidence of disability
Cumulative incidence of disability measured through Lawton instrumental activities of daily living (IADL) assessment. Disability is defined as any assistance needed for a specific IADL domain, and measured by a worsening of disability score by one or more IADL within one year.
Time frame: 1 Year
Cumulative incidence of admission to a skilled nursing facility
Cumulative incidence of admission to a skilled nursing facility
Time frame: 1 Year
HRQOL using PROMIS domains
Health Related Quality of Life as measured using the PROMIS Global Health Physical Function, Anxiety, and Depression domains on scales from 0-100 where 50 is the mean score in a healthy reference population. A higher score indicates 'more' of that domain - for this study that would be more physical function, more anxiety, or more depression than the reference population.
Time frame: 1 Year
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Cumulative incidence of serious organ toxicity by day 100
Cumulative incidence of serious organ toxicity by day 100
Time frame: 100 Days
Cumulative incidence of acute grade 2-4 GVHD
Cumulative incidence of acute grade 2-4 GVHD at 100 days, 6 months and 1 year and chronic GVHD requiring treatment with systemic immune-suppression at 6 months and 1 year
Time frame: 100 days
Cumulative incidence of acute grade 2-4 GVHD
Cumulative incidence of acute grade 2-4 GVHD at 100 days, 6 months and 1 year and chronic GVHD requiring treatment with systemic immune-suppression at 6 months and 1 year
Time frame: 6 months
Cumulative incidence of acute grade 2-4 GVHD
Cumulative incidence of acute grade 2-4 GVHD at 100 days, 6 months and 1 year and chronic GVHD requiring treatment with systemic immune-suppression at 6 months and 1 year
Time frame: 1 year
Chronic GVHD requiring treatment with systemic immune-suppression
Cumulative incidence of acute grade 2-4 GVHD at 100 days, 6 months and 1 year and chronic GVHD requiring treatment with systemic immune-suppression at 6 months and 1 year
Time frame: 6 months
Chronic GVHD requiring treatment with systemic immune-suppression
Cumulative incidence of acute grade 2-4 GVHD at 100 days, 6 months and 1 year and chronic GVHD requiring treatment with systemic immune-suppression at 6 months and 1 year
Time frame: 1 year
Survival after development of acute grade 2-4 GVHD
Survival after development of acute grade 2-4 GVHD
Time frame: 1 year
Cognitive decline at day 100
Cognitive decline at day 100 as measured using the Montreal Cognitive Assessment (MoCA) as a rapid screening instrument for mild genitive dysfunction. MoCA uses a scale of 0-30 where 26-30 indicates the normal range in healthy populations. Cognitive decline will be defined as a 2 point or greater decline from baseline on total score.
Time frame: Day 100