Composite Health Assessment Risk Model (CHARM) for Older Adults (BMT CTN 1704)
- Conditions
- Hematologic Malignancy
- Registration Number
- NCT03992352
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1229
- Subject is > 60.0 years old at time of enrollment.
- Hematological malignancy as an indication for allogeneic transplantation.
- Eligible for allogeneic transplantation based on institutional standards
- First allogeneic transplant planned. Any conditioning regimen and allogeneic donor is acceptable.
- Able to speak and read English. Spanish, and Mandarin will be acceptable when sites have ability to perform healthcare provider tests in those languages.
- Written informed consent
- Prior allogeneic HCT
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method One Year Non-Relapse Mortality 1 year 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.
- Secondary Outcome Measures
Name Time Method Cumulative Incidence of Frailty 1 Year 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'.
HRQOL using PROMIS domains 1 Year 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.
Cumulative incidence of serious organ toxicity by day 100 100 Days Cumulative incidence of serious organ toxicity by day 100
Cumulative incidence of admission to a skilled nursing facility 1 Year Cumulative incidence of admission to a skilled nursing facility
Overall survival 1 year Overall survival
Cumulative incidence of disability 1 Year 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.
Cognitive decline at day 100 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.
Cumulative incidence of acute grade 2-4 GVHD 1 year 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
Chronic GVHD requiring treatment with systemic immune-suppression 1 year 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
Survival after development of acute grade 2-4 GVHD 1 year Survival after development of acute grade 2-4 GVHD
Trial Locations
- Locations (50)
Mayo Clinic Arizona and Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Stanford University
🇺🇸Stanford, California, United States
University of Florida
🇺🇸Gainesville, Florida, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Memorial Cancer Institute
🇺🇸Pembroke Pines, Florida, United States
H. Lee Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Northside Hospital
🇺🇸Atlanta, Georgia, United States
Scroll for more (40 remaining)Mayo Clinic Arizona and Phoenix Children's Hospital🇺🇸Phoenix, Arizona, United States