A Controlled Study of Stem Cell Transplantation Medical Home Care Compared to Standard Hospital Care
Status: | Active, not recruiting |
---|---|
Conditions: | Blood Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 4/3/2019 |
Start Date: | February 2012 |
End Date: | June 2019 |
The primary goal with this study is to document whether patients can maintain their normal
bowel microbiota by staying at home compared to those who live at home but are treated in
clinic, and those who are treated in the hospital. In addition, the investigators would
predict that the quality of life will be higher for those patients treated at the medical
home compared to those that stay at the hospital. The investigators also predict that the
costs associated with this approach will be significantly lower compared to hospitalized
patients. Finally, the investigators propose that the treatment related morbidities and
mortality will not be different between the two groups.
bowel microbiota by staying at home compared to those who live at home but are treated in
clinic, and those who are treated in the hospital. In addition, the investigators would
predict that the quality of life will be higher for those patients treated at the medical
home compared to those that stay at the hospital. The investigators also predict that the
costs associated with this approach will be significantly lower compared to hospitalized
patients. Finally, the investigators propose that the treatment related morbidities and
mortality will not be different between the two groups.
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.
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.
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
Durham, North Carolina 27710
919-684-8111

Principal Investigator: Nelson Chao, MD, MBA
Phone: 919-684-7115
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
Click here to add this to my saved trials
