A Controlled Study of Stem Cell Transplantation Medical Home Care Compared to Standard Hospital Care
Subjects enrolled in the medical home arm and those serving as concurrent controls will have
the following studies:
1. Stool collection for analysis at time 0 (prior to preparatory regimen) and then weekly
for the first four weeks, at day 60 and 100.
2. The PG-SGA, FACT-BMT and other patient-reported symptom instruments will be collected
weekly for the first 4 weeks, at day 60, 100 and patients will be required to complete
a daily food diary.
3. Other assessments for toxicities or GVHD will proceed as per current standard of care,
for a total blood draw amount of 100 mls from home care subjects and concurrent
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
The bowel microbiota before and during the first 100 days.
Nelson Chao, MD, MBA
United States: Institutional Review Board
|Duke University Medical Center||Durham, North Carolina 27710|