Clinical trial NCT01725022: A Controlled Study of Stem Cell Transplantation Medical Home Care Compared to Standard Hospital Care
Official title: A Controlled Study of Stem Cell Transplantation Medical Home Care Compared to Standard Hospital Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematologic Malignancies
Keywords: stem cell transplant
bowel microbiota
home care
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2012-11-12
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bowel Microbiota
timeFrame: 100 days
Secondary outcomes:
measure: Nutritional status using the PG-SGA assessment tool
timeFrame: 100 days
measure: Incidence of acute Graft Versus Host Disease (GVHD)
timeFrame: 100 days
measure: Treatment related morbidities and mortalities
timeFrame: 100 Days
measure: Quality Of Life Assessment (QOL)
timeFrame: 100 Days
measure: Costs of care
timeFrame: 100 Days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Nelson Chao, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: