A Controlled Study of Stem Cell Transplantation Medical Home Care Compared to Standard Hospital Care
18 Years
80 Years
Both
Hematologic Malignancies
Trial Information
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
controls.
Inclusion Criteria:
1. Scheduled to undergo a hematopoietic stem cell transplant for any cancer or
non-cancer illness from any autologous, related or unrelated donor source including
bone marrow, peripheral blood progenitor cell, or umbilical cord blood
2. Age 18-80 years of age
3. Karnofsky Performance Scale (KPS) > 80
4. A home that is deemed, upon inspection, in suitable condition to serve as a medical
home, within a 90-minute driving distance of Duke (home care group only)
Exclusion Criteria:
1. Lack of a caregiver
2. Pregnant women (It is standard of care to assess for pregnancy for all females of
child-bearing potential with a serum beta human chorionic gonadotropin (HCG) test
within 7 days of starting the preparative regimen prior to transplant. No additional
research pregnancy testing will occur.)
3. Patients with a documented active infection prior to starting their preparative
regimen. This includes grade 3 or higher viral, bacterial, or fungal infection.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Outcome Measure:
Bowel Microbiota
Outcome Description:
The bowel microbiota before and during the first 100 days.
Outcome Time Frame:
100 days
Safety Issue:
Yes
Principal Investigator
Nelson Chao, MD, MBA
Investigator Role:
Principal Investigator
Investigator Affiliation:
Duke University
Authority:
United States: Institutional Review Board
Study ID:
Pro00032263
NCT ID:
NCT01725022
Start Date:
February 2012
Completion Date:
June 2019
Related Keywords:
- Hematologic Malignancies
- stem cell transplant
- bowel microbiota
- home care
- Neoplasms
- Hematologic Neoplasms
Name | Location |
|---|---|
| Duke University Medical Center | Durham, North Carolina 27710 |
